Inova Diagnostics, Inc.
San Diego, CA, US
INOVA DIAGNOSTICS, INC. appears in FDA device records in San Diego, CA. FDA records list 138 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Inova 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.
- Inova Diagnostics Incorporatedenforcement report, recall
510(k) clearance history
Showing 50 of 138FDA records hold 138 510(k) clearances for Inova Diagnostics, Inc. between 1988 and 2026. The busiest year on record is 1998, with 13. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 8 |
| 1989 | 5 |
| 1990 | 4 |
| 1991 | 1 |
| 1992 | 8 |
| 1993 | 5 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 5 |
| 1997 | 9 |
| 1998 | 13 |
| 1999 | 5 |
| 2000 | 3 |
| 2001 | 6 |
| 2002 | 3 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 6 |
| 2006 | 3 |
| 2007 | 4 |
| 2008 | 5 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 3 |
| 2014 | 1 |
| 2015 | 9 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243979 | Aptiva APS IgA Reagent | MSV | Substantially Equivalent | |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | MID | Substantially Equivalent | |
| K213403 | Aptiva CTD Essential Reagent | LLL | Substantially Equivalent | |
| K200230 | Aptiva Celiac Disease IgG Reagent | MVM | Substantially Equivalent | |
| K193604 | Aptiva Celiac Disease IgA Reagent | MVM | Substantially Equivalent | |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | KTL | Substantially Equivalent | |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | DHR | Substantially Equivalent | |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | NXO | Substantially Equivalent | |
| K180975 | QUANTA Flash HMGCR Reagents | LLL | Substantially Equivalent | |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | NXO | Substantially Equivalent | |
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | NBS | Substantially Equivalent | |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | DBM | Substantially Equivalent | |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | MOB | Substantially Equivalent | |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls | LLL | Substantially Equivalent | |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | LSW | Substantially Equivalent | |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols | LLL | Substantially Equivalent | |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls | MSV | Substantially Equivalent | |
| K153150 | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 | PIV | Substantially Equivalent | |
| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | NHX | Substantially Equivalent | |
| DEN140039 | NOVA View Automated Fluorescense Microscope | PIV | Unknown | |
| K150155 | NOVA Lite DAPI ANA Kit | DHN | Substantially Equivalent | |
| K141655 | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS | OBE | Substantially Equivalent | |
| K141274 | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. | MSV | Substantially Equivalent | |
| K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS | LLL | Substantially Equivalent | |
| K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS | LLL | Substantially Equivalent | |
| K123880 | QUANTA FLASH CENTROMERE | LJM | Substantially Equivalent | |
| K122923 | QUANTA FLASH ENA7 | LLL | Substantially Equivalent | |
| K123593 | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, | LKP | Substantially Equivalent | |
| K120817 | QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA | MID | Substantially Equivalent | |
| K113863 | QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS | MST | Substantially Equivalent | |
| K112545 | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM | MOB | Substantially Equivalent | |
| K111414 | QUANTA FLASH (TM) DGP SCREEN | MST | Substantially Equivalent | |
| K101644 | QUANTA FLASH H-TTG IGG | MVM | Substantially Equivalent | |
| K094060 | QUANTA FLASH H-TTG IGA | MVM | Substantially Equivalent | |
| K090755 | QUANTA LITE APS/PT IGG AND IGM ELISA | OPN | Substantially Equivalent | |
| K081248 | QUANTA LITE OMP PLUS ELISA | OKM | Substantially Equivalent | |
| K072944 | QUANTA LITE CCP3.1 IGG/IGA ELISA | NHX | Substantially Equivalent | |
| K073145 | QUANTA LITE H-TTG SCREEN | MVM | Substantially Equivalent | |
| K072632 | QUANTA PLEX CELIAC IGG PROFILE | MVM | Substantially Equivalent | |
| K072967 | QUANTA LITE F-ACTIN IGA ELISA | MVM | Substantially Equivalent | |
| K063818 | QUANTA PLEX CELIAC IGA PROFILE | MVM | Substantially Equivalent | |
| K070066 | QUANTA LITE RNA POL III ELISA | NYO | Substantially Equivalent | |
| K063565 | QUANTA LITE SS-A 52 ELISA | OBE | Substantially Equivalent | |
| K070083 | QUANTA LITE H-TTG/DGP SCREEN | MST | Substantially Equivalent | |
| K061841 | QUANTA LITE INTRINSIC FACTOR ELISA | LIG | Substantially Equivalent | |
| K062708 | QUANTA LITE CELIAC DGP SCREEN | MST | Substantially Equivalent | |
| K061842 | QUANTA LITE PBC SCREEN IGG/IGA ELISA | NRI | Substantially Equivalent | |
| K052264 | QUANTA LITE CCP3 IGG ELISA | NHX | Substantially Equivalent | |
| K052262 | QUANTA LITE M2 EP (MIT3) ELISA | DBM | Substantially Equivalent | |
| K052143 | QUANTA LITE GLIADIN IGA II | MST | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2026994 | 2026994 | INOVA DIAGNOSTICS, INC. | 9900 Old Grove Rd, SAN DIEGO, CA 92131 US | 2026 | and 36 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- LSWAnti-Dna Antibody, Antigen And Control
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase
- MQAAnti-Ribosomal P Antibodies
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- OBEAnti-Ss-A 52 Autoantibodies
- NJFAntibodies, Anti-Actin, Anti-Smooth Muscle
- NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
- MSTAntibodies, Gliadin
- OKMAntibodies, Outer-Membrane Proteins
- NBTAntibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- OPNAuto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
- NYOAutoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
- NIYAutoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
- MVMAutoantibodies, Endomysial(Tissue Transglutaminase)
- NBSAutoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
- NUMAutoantibodies, Nuclear Body Protein, Sp100
- NRIAutoantibodies, Nuclear Pore Glycoprotein Gp210
- PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- NXOCalprotectin, Fecal
- DAKComplement C1q, Antigen, Antiserum, Control
- MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
- MLEEnzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LLLExtractable Antinuclear Antibody, Antigen And Control
- PPMGeneral Purpose Reagent
- LYRHelicobacter Pylori
- DGCIge, Antigen, Antiserum, Control
- DASIgg (Fc Fragment Specific), Antigen, Antiserum, Control
- NSUInstrumentation For Clinical Multiplex Test Systems
- OHQMulti-Analyte Controls Unassayed
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- LIGRadioassay, Intrinsic Factor Blocking Antibody
- LSRReagent, Borrelia Serological Reagent
- MVUReagents, Specific, Analyte
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- MIDSystem, Test, Anticardiolipin Immunological
- DHRSystem, Test, Rheumatoid Factor
- JZOSystem, Test, Thyroid Autoantibody
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
- DDCThyroglobulin, Antigen, Antiserum, Control
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1222-2018 | QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates. | The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument. | Class II | Terminated | |
| Z-1221-2018 | QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates. | The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument. | Class II | Terminated | |
| Z-0280-2012 | Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic. | The NOVA Lite ANA KSL kit label has the wrong fill volume for the IFA System Negative Control (P/N 508186) with 1mL. The component in the kit is correctly labeled and filled with the 0.5mL fill volume. | Terminated | ||
| Z-1942-2010 | Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021 | The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as "tissue Transglutaminase Coated Wells" instead of "C1q Coated Wells". | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain