Microgenics Corporation
Fremont, CA, US
Microgenics Corporation appears in FDA device records in Fremont, CA. FDA records list 128 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 14 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 128FDA records hold 128 510(k) clearances for Microgenics Corporation between 1985 and 2024. The busiest year on record is 1994, with 28. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 5 |
| 1991 | 5 |
| 1992 | 5 |
| 1993 | 2 |
| 1994 | 28 |
| 1995 | 13 |
| 1996 | 2 |
| 2000 | 2 |
| 2001 | 4 |
| 2002 | 1 |
| 2003 | 6 |
| 2004 | 5 |
| 2005 | 2 |
| 2006 | 2 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 11 |
| 2012 | 2 |
| 2013 | 4 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent Kit | JXM | Substantially Equivalent | |
| K240670 | DRI Ecstasy Plus Assay | DKZ | Substantially Equivalent | |
| K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | LFH | Substantially Equivalent | |
| K231007 | CEDIA Heroin Metabolite (6-AM) Assay | DJG | Substantially Equivalent | |
| K213875 | DRI TM Tricyclics Serum Tox Assay | LFH | Substantially Equivalent | |
| K211973 | DRI Cocaine Metabolite Assay | DIO | Substantially Equivalent | |
| K192943 | CEDIA Heroin Metabolite (6-AM) assay | DJG | Substantially Equivalent | |
| K190968 | CEDIA Benzodiazepine Assay | JXM | Substantially Equivalent | |
| DEN180030 | QMS Plazomicin Immunoassay | QDR | Unknown | |
| K181499 | DRI Cocaine Metabolite Assay | DIO | Substantially Equivalent | |
| K173963 | DRI Benzodiazepine Assay | JXM | Substantially Equivalent | |
| K173195 | DRI Hydrocodone Assay | DJG | Substantially Equivalent | |
| K173183 | CEDIA Heroin Metabolite (6-AM) Assay | DJG | Substantially Equivalent | |
| K163101 | CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set | DJG | Substantially Equivalent | |
| K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls | DJG | Substantially Equivalent | |
| K122766 | THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY | OUF | Substantially Equivalent | |
| K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | MLM | Substantially Equivalent | |
| K123518 | ABBOTT CARBAMAZEPINE ASSAY | KLT | Substantially Equivalent | |
| K123271 | ABBOTT PHENOBARBITAL ASSAY | DLZ | Substantially Equivalent | |
| K120936 | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS | DKB | Substantially Equivalent | |
| K122291 | THERMO SCIENTIFIC MAS OMNI-CARDIO | JJY | Substantially Equivalent | |
| K110738 | THERMO SCIENTIFIC MAS OMNI-CORE | JJY | Substantially Equivalent | |
| K110616 | THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO | JJY | Substantially Equivalent | |
| K101754 | THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY | DJG | Substantially Equivalent | |
| K101753 | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY | LAF | Substantially Equivalent | |
| K101752 | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | DKB | Substantially Equivalent | |
| K101746 | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY | LCM | Substantially Equivalent | |
| K101745 | THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY | DKZ | Substantially Equivalent | |
| K101744 | THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY | LDJ | Substantially Equivalent | |
| K101742 | THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY | DIO | Substantially Equivalent | |
| K103656 | THERMO SCIENTIFIC MAS R DOA TOTAL | DIF | Substantially Equivalent | |
| K100144 | THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS | OUF | Substantially Equivalent | |
| K093114 | THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY | DKZ | Substantially Equivalent | |
| K092749 | MAS AND MINI-TROL PTH CONTROL | JJX | Substantially Equivalent | |
| K092051 | THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 | JJY | Substantially Equivalent | |
| K090810 | THERMO SCIENTIFIC CYTO-CAL COUNT TUBES | GKZ | Substantially Equivalent | |
| K061196 | CARDIOIMMUNE XL CARDIAC MARKER CONTROL | JJY | Substantially Equivalent | |
| K053411 | DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS | LCP | Substantially Equivalent | |
| K051074 | MAS IMMUNOSUPPRESSANT CONTROLS | LAS | Substantially Equivalent | |
| K050206 | CEDIA TACROLIMUS ASSAY | MLM | Substantially Equivalent | |
| DEN040008 | CEDIA SIROLIMUS ASSAY | NRP | Unknown | |
| K040316 | CEDIA BUPRENORPHINE ASSAY | DJG | Substantially Equivalent | |
| K040758 | MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT | DIF | Substantially Equivalent | |
| K040411 | DRI OXYCODONE ASSAY | LAS | Substantially Equivalent | |
| K041073 | DOCUMENT SALICYLATE CAL VER | JJY | Substantially Equivalent | |
| K032811 | CEDIA VANCOMYCIN ASSAY | LEH | Substantially Equivalent | |
| K032842 | MICROGENICS CYCLOSPORINE CONTROL KIT | LAS | Substantially Equivalent | |
| K023617 | DRI METHADONE METABOLITE ENZYME IMMUNOASSAY | DJR | Substantially Equivalent | |
| K030649 | DRI COTININE EIA ASSAY | MRS | Substantially Equivalent | |
| K030616 | CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 | LAS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010939897 | 3010939897 | Microgenics Corporation | 46500 Kato Road, Fremont, CA 94538 US | 2026 | and 57 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- DKCAlcohol Control Materials
- LCPAssay, Glycosylated Hemoglobin
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DKBCalibrators, Drug Mixture
- DLJCalibrators, Drug Specific
- DNNCalibrators, Ethyl Alcohol
- LDPColorimetry, Acetaminophen
- GKZCounter, Differential Cell
- DIFDrug Mixture Control Materials
- LASDrug Specific Control Materials
- DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- KLTEnzyme Immunoassay, Carbamazepine
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- LFMEnzyme Immunoassay, Digitoxin
- KXTEnzyme Immunoassay, Digoxin
- DIPEnzyme Immunoassay, Diphenylhydantoin
- LCDEnzyme Immunoassay, Gentamicin
- KLREnzyme Immunoassay, Lidocaine
- DJREnzyme Immunoassay, Methadone
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- DLZEnzyme Immunoassay, Phenobarbital
- LAREnzyme Immunoassay, Procainamide
- JXNEnzyme Immunoassay, Propoxyphene
- LBZEnzyme Immunoassay, Quinidine
- KLSEnzyme Immunoassay, Theophylline
- LEGEnzyme Immunoassay, Valproic Acid
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- LERFluorescent Immunoassay, Theophylline
- LCRFluorescent Immunoassay, Tobramycin
- JFTFluorometric, Cortisol
- IGCFormalin-Saline
- LAFGas Chromatography, Methamphetamine
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JQYPh Meter
- JGJPhotometric Method, Magnesium
- KHQRadioassay, Triiodothyronine Uptake
- CDDRadioassay, Vitamin B12
- JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin
- KLQRadioimmunoassay, Amikacin
- CGRRadioimmunoassay, Cortisol
- DLBRadioimmunoassay, Lsd (125-I)
- KXSRadioimmunoassay, Methaqualone
- CDPRadioimmunoassay, Total Triiodothyronine
- LEHRadioimmunoassay, Vancomycin
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- IGDSolution, Formol Calcium
- IBGTrypsin
- LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs
- EIAUnit, Operative Dental
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0415-2026 | Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control | The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays. | Class II | Open, Classified | |
| Z-1284-2022 | QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3 | Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay. | Class II | Open, Classified | |
| Z-0008-2017 | Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country. | A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed. Bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% when comparing the QMS everolimus assay to an everolimus LC-MS reference method. Patient samples across the measuring range sub-therapeutic, therapeutic, and supra-therapeutic could be affected. | Class II | Terminated | |
| Z-2884-2016 | DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma. | Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL. | Class II | Terminated | |
| Z-0501-2015 | MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations. | MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32). | Class II | Terminated | |
| Z-1930-2014 | MAS Omni Immune PRO Controls | The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change. | Class III | Terminated | |
| Z-1929-2014 | MAS Omni Immune Controls | The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change. | Class III | Terminated | |
| Z-0513-2014 | Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma. | Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received. | Class II | Terminated | |
| Z-2267-2013 | DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result. | Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation. | Class II | Terminated | |
| Z-1563-2013 | Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. | It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability. | Class II | Terminated | |
| Z-0379-2013 | Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. . | In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability. | Class III | Terminated | |
| Z-0637-2012 | ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack; | Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges. | Terminated | ||
| Z-0773-2012 | Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538; Distributed by Abbott Diagnostics, 100 Abbott Park Road, Abbott Park, Illinois 60064. .Tobramycin is a commonly used antibiotic to treat bacterial infections, in particular gram negative infections. | Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range. | Terminated | ||
| Z-0297-2012 | Multigent Vancomycin Calibrators; Manufactured by Microgenics Corp, Fremont, CA. Distributed by: Abbott Diagnostics, Abbott Park, IL Product Usage: The Multigent Vancomycin calibrators are intended for use in the calibration of the multiagent vancomycin Vancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections. | Complaint from the sole distributor that the third party control material is recovering high, and outside the published range. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain