Accriva Diagnostics, Inc.
San Diego, CA, US
Accriva Diagnostics, Inc. appears in FDA device records in San Diego, CA. FDA records list 51 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 33 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Accriva Diagnostics, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Accriva Diagnostics Inc., dba ITC, dba Accumetricsenforcement report, recall
- International Technidyne Corporation510(k), enforcement report, recall
- ITC-Nexus Dxenforcement report, recall
510(k) clearance history
Showing 50 of 51FDA records hold 51 510(k) clearances for Accriva Diagnostics, Inc. between 1983 and 2023. The busiest year on record is 1991, with 8. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1985 | 1 |
| 1987 | 1 |
| 1988 | 3 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 8 |
| 1992 | 3 |
| 1993 | 4 |
| 1994 | 6 |
| 1995 | 3 |
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 2 |
| 2005 | 2 |
| 2013 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223352 | Tenderfoot | FMK | Substantially Equivalent | |
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 | JPA | Substantially Equivalent | |
| K193041 | Hemochron Signature Elite | JPA | Substantially Equivalent | |
| K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | GGN | Substantially Equivalent | |
| K050983 | IRMA TRUPOINT CREATININE CONTROL KIT | JJX | Substantially Equivalent | |
| K050016 | HEMOCHRON SIGNATURE ELITE | JPA | Substantially Equivalent | |
| K030818 | HEMOCHRON RESPONSE/SYSTEM | JPA | Substantially Equivalent | |
| K023561 | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM | GKR | Substantially Equivalent | |
| K020798 | HEMOCHRON JR. SIGNATURE + | JPA | Substantially Equivalent | |
| K010599 | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE | GJS | Substantially Equivalent | |
| K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | KFF | Substantially Equivalent | |
| K983475 | HEMOCHRON RESPONSE | KQG | Substantially Equivalent | |
| K990449 | HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE | JPA | Substantially Equivalent | |
| K972866 | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT | GJS | Substantially Equivalent | |
| K974799 | HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE | JPA | Substantially Equivalent | |
| K972831 | HEMOCHRON CITRATE APTT | GFO | Substantially Equivalent | |
| K961835 | PROTIME MICROCOAGULATION SYSTEM | GJS | Substantially Equivalent | |
| K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | JBP | Substantially Equivalent | |
| K951072 | PROTIME MICROCOAGULATION SYSTEM | GKP | Substantially Equivalent | |
| K945078 | HEMOCHRON HNPT/FACTOR VI PT+ | GJS | Substantially Equivalent | |
| K944691 | ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II | GGN | Substantially Equivalent | |
| K940957 | HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM | JPA | Substantially Equivalent | |
| K941007 | CATALOG NO. J-ACT+ & QC-ACT+ | JBP | Substantially Equivalent | |
| K941159 | DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G | JKA | Substantially Equivalent | |
| K940432 | MICROCOAGULATION PROTHROMBIN TIME TEST | GJS | Substantially Equivalent | |
| K940401 | JR. MICROCOAGULATION SYSTEM | JPA | Substantially Equivalent | |
| K935081 | DIRECTDRAW SUPERSERUM-MINI | JKA | Substantially Equivalent | |
| K924637 | HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT | GFO | Substantially Equivalent | |
| K923302 | TENDERLETT FINGER | FMK | Substantially Equivalent | |
| K923761 | ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM | JPA | Substantially Equivalent | |
| K924638 | HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT | GFO | Substantially Equivalent | |
| K923593 | HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS | KQJ | Substantially Equivalent | |
| K921778 | DIRECTDRAW SUPERSERUM | GIM | Substantially Equivalent | |
| K915344 | HEMOCHRON ONESTEP APTT TEST | GFO | Substantially Equivalent | |
| K913861 | HEMOCHRON(R) KACT | JBP | Substantially Equivalent | |
| K911997 | TENDERFOOT(R), MODIFICATION | FMK | Substantially Equivalent | |
| K911996 | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION | JCA | Substantially Equivalent | |
| K911995 | PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION | GJS | Substantially Equivalent | |
| K911994 | HEMOCHRON(R) APTT, MODIFICATION | GFO | Substantially Equivalent | |
| K910646 | SUPERSERUM REAGENT (SSR) | JKA | Substantially Equivalent | |
| K910181 | HITT BY HEMOCHRON(R) | KFF | Substantially Equivalent | |
| K910105 | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 | GFT | Substantially Equivalent | |
| K904454 | HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION | GJS | Substantially Equivalent | |
| K900126 | TT AND HNTT BY HEMOCHRON | GJA | Substantially Equivalent | |
| K893378 | PROTHROMBIN TIME (PT) BY HEMOCHRON | GJS | Substantially Equivalent | |
| K883968 | TENDERFOOT | FMK | Substantially Equivalent | |
| K882481 | HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II | GGN | Substantially Equivalent | |
| K882480 | HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II | GGN | Substantially Equivalent | |
| K870831 | PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA | JPA | Substantially Equivalent | |
| K850542 | SURGICUTT - BLEEDING TIME DEVICE | JCA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002721930 | 2250033 | Accriva Diagnostics, Inc. | 6260 Sequence Drive, San Diego, CA 92121 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GFOActivated Partial Thromboplastin
- JBPActivated Whole Blood Clotting Time
- KFFAssay, Heparin
- JCADevice, Bleeding Time
- FRLFiber, Medical, Absorbent
- KQGInstrument, Coagulation
- GKPInstrument, Coagulation, Automated
- DQAOximeter
- GGNPlasma, Coagulation Control
- GFTProtamine Sulphate
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- JOZSystem, Automated Platelet Aggregation
- KQJSystem, Fibrinogen Determination
- GKRSystem, Hemoglobin, Automated
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- GJATest, Thrombin Time
- GJSTest, Time, Prothrombin
- GIMTubes, Vacuum Sample, With Anticoagulant
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
Showing 25 of 33| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2460-2026 | directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2 | Assayed Whole blood control contains labeling with incorrect performance range. | Class II | Open, Classified | |
| Z-0880-2026 | Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System | Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling. | Class II | Open, Classified | |
| Z-0500-2026 | VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. | Due to an device without a premarket clearance being incorrectly package and distributed. | Class III | Open, Classified | |
| Z-0961-2025 | VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 | Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor. | Class II | Open, Classified | |
| Z-0279-2025 | AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter. | Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention. | Class II | Completed | |
| Z-1121-2022 | The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of activated platelets to bind fibrinogen. Fibrinogen-coated microparticles aggregate in whole blood in proportion to the number of expressed platelet GP IIb/IIIa receptors. Light transmittance increases as activated platelets bind and aggregate fibrinogen-coated beads. The instrument measures this change in optical signal and reports results in P2Y12 Reaction Units (PRU). The rate of microbead aggregation is more rapid and reproducible if platelets are activated; therefore, the reagent adenosine-5-diphosphate (ADP) is incorporated into the test channel to induce platelet activation. Prostaglandin E1 (PGE1) is included in the reagent mixture to increase the specificity of the PRU result to reflect P2Y12-mediated platelet aggregation. The reagents are formulated such to achieve reaction concentrations of 20 M ADP and 22 nM PGE1. In a like manner, two other activators, iso-TRAP (Thrombin Receptor Activating Peptide) with PAR4-AP (PAR4-Activating Peptide) and fibrinogen-coated microparticles are incorporated into a second channel of the test device. The instrument measures the change in transmittance in this channel, calculates the baseline platelet function for the sample, and reports the percent inhibition result for the sample. | Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition. | Class II | Terminated | |
| Z-1720-2016 | Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012. | Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result. | Class II | Terminated | |
| Z-2088-2014 | Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103. | Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples. | Class II | Terminated | |
| Z-0937-2014 | Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity. | ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals. | Class II | Terminated | |
| Z-0137-2014 | Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations. | ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose. | Class II | Terminated | |
| Z-0837-2013 | Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood. | Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results. | Class II | Terminated | |
| Z-2953-2011 | Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp (ITC)-Nexus Dx. A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time. | Certain lots of Hemochron Jr. PT Cuvettes (J201) demonstrate a higher bias than historically observed when compared to laboratory reference instruments. | Terminated | ||
| Z-2954-2011 | IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time. | Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than historically observed when compared to laboratory reference. instruments. | Terminated | ||
| Z-2218-2011 | AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use int he cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated. | An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments. | Terminated | ||
| Z-1854-2011 | HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility and is not intended for home use. | ITC has determined that results obtained using certain lots of Hgb Pro Professional Hemoglobin Test Strips may differ from results obtained using a reference hemoglobin testing system. | Terminated | ||
| Z-1093-2011 | Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care. | Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot. | Terminated | ||
| Z-2108-2010 | GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk. Manufactured for Instrumentation Laboratory Company, Lexington, MA 02421-3125. Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory. | Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published. | Terminated | ||
| Z-2107-2010 | GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061600. Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125. Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory. | Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published. | Terminated | ||
| Z-2200-2010 | International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic 15 vials For performance of Level 1 quality control ACT-LR test cuvettes on the Hemochron Microcoagulation Systems. | The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes | Terminated | ||
| Z-2110-2010 | RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. 20 vials Whole Blood - 2.0mL; dried 20 vials Diluent - 4.0 mL The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes. | An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may become less potent over time and result in excessive High LQC Failures. | Terminated | ||
| Z-1786-2010 | directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems. | Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect. | Terminated | ||
| Z-2438-2010 | Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854 | A tabulation error in the Integrated Data Management Systems (IDMS) data management software that results in incorrect Electronic Quality Control (EQC) Summary Reports: The Operator and the Device Performance Summary Reports. The IDMS software is not used for the clinical management of individual patients. | Terminated | ||
| Z-0893-2011 | Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. The system is intended to be used only with test cuvettes that are available from ITC. | There is a mismatch between the class of the laser barcode scanner and the labeling of the Hemochron Signature Elite: some of the devices were inadvertently equipped with class II laser barcode scanner instead of the intended class I barcode scanner. | Terminated | ||
| Z-1732-2009 | Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the HEMOCHROM Whole Blood Microagulation Systems; International Technidyne Corp., Edison, NJ 08820. The HEMOCHRON Jr. ACT-LR is a quantitative assay for monitoring heparin anticoagulation during various medical procedures. The ACT-LR demonstrated linear correlation to the anticoagulation effects of heparin up to 2.5 unit/ml of blood. It is intended for use in monitoring low to moderate heparin doses frequently associated with procedures such as cardiac catheterization, Extracorporeal Membrane Oxygenation (ECMO) Hemodialysis, and Percutaneous Transluminal Coronary Angioplasty. | One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria. | Terminated | ||
| Z-1239-2008 | International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220 | Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain