Inova Diagnostics, Inc.
Medical device manufacturer in San Diego, CA.
136510(k) clearances
0PMA approvals
4recalls
Device types
- LLL Extractable Antinuclear Antibody, Antigen… 37
- MVM Autoantibodies, Endomysial(Tissue… 12
- MID System, Test, Anticardiolipin Immunological 9
- MOB Test System, Antineutrophil Cytoplasmic… 8
- MST Antibodies, Gliadin 8
- MSV System,Test,Antibodies,B2 - Glycoprotein I… 7
- DHN Antinuclear Antibody, Indirect… 4
- NHX Antibodies, Anti-Cyclic Citrullinated… 4
- DHR System, Test, Rheumatoid Factor 4
- LJM Antinuclear Antibody (Enzyme-Labeled)… 3
- LSR Reagent, Borrelia Serological Reagent 3
- NXO Calprotectin, Fecal 2
- OBE Anti-Ss-A 52 Autoantibodies 2
- NRI Autoantibodies, Nuclear Pore Glycoprotein… 2
- DBM Antimitochondrial Antibody, Indirect… 2
- JZO System, Test, Thyroid Autoantibody 2
- NBS Autoantibodies, Lkm-1 (Liver/Kidney… 2
- LYR Helicobacter Pylori 2
- LJB Enzyme Linked Immunoabsorbent Assay… 1
- LFZ Enzyme Linked Immunoabsorbent Assay… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243979 | Aptiva APS IgA ReagentMSV · Traditional | 02/06/2026SE |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM ReagentMID · Traditional | 12/17/2024SE |
| K213403 | Aptiva CTD Essential ReagentLLL · Traditional | 09/29/2023SE |
| K200230 | Aptiva Celiac Disease IgG ReagentMVM · Traditional | 08/26/2021SE |
| K193604 | Aptiva Celiac Disease IgA ReagentMVM · Traditional | 06/16/2021SE |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL · Traditional | 12/11/2020SE |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional | 04/17/2019SE |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | 10/16/2018SE |
| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | 06/25/2018SE |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash…NXO · Traditional | 12/22/2017SE |
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1…NBS · Traditional | 09/06/2017SE |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3)…DBM · Traditional | 09/05/2017SE |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitMOB · Traditional | 02/03/2017SE |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsLLL · Traditional | 06/01/2016SE |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsLSW · Traditional | 04/11/2016SE |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsLLL · Traditional | 02/12/2016SE |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar…MSV · Traditional | 12/21/2015SE |
| K153150 | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000PIV · Special | 11/24/2015SE |
| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3NHX · Traditional | 09/21/2015SE |
| K150155 | NOVA Lite DAPI ANA KitDHN · Traditional | 04/08/2015SE |
| K141655 | Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 ControlsOBE · Traditional | 03/05/2015SE |
| K141274 | Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar ANTI-¿2GPI DOMAIN1; Controls.MSV · Traditional | 02/13/2015SE |
| K141328 | Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 ControlsLLL · Traditional | 02/12/2015SE |
| K141210 | Quanta Flash Ss-B, Quanta Flash Ss-B Calibrators, and Quanta Flash Ss-B ControlsLLL · Traditional | 01/29/2015SE |
| K123880 | Quanta Flash CentromereLJM · Traditional | 02/07/2014SE |
| K122923 | Quanta Flash ENA7LLL · Traditional | 05/07/2013SE |
| K123593 | Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP…LKP · Traditional | 04/17/2013SE |
| K120817 | Quanta Flash Acl Lga, Quanta Flash B2GP1 IgaMID · Traditional | 02/26/2013SE |
| K113863 | Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta…MST · Traditional | 09/20/2012SE |
| K112545 | Quanta Flash PR3, Quanta Flash Mpo, Quanta Flash GBMMOB · Traditional | 07/31/2012SE |
| K111414 | Quanta Flash (TM) DGP ScreenMST · Traditional | 10/20/2011SE |
| K101644 | Quanta Flash H-Ttg IggMVM · Traditional | 03/23/2011SE |
| K094060 | Quanta Flash H-Ttg IgaMVM · Traditional | 10/13/2010SE |
| K090755 | Quanta Lite Aps/Pt Igg and Igm ElisaOPN · Traditional | 02/01/2010SE |
| K081248 | Quanta Lite Omp Plus ElisaOKM · Traditional | 10/27/2008SE |
| K072944 | Quanta Lite CCP3.1 Igg/Iga ElisaNHX · Traditional | 03/05/2008SE |
| K073145 | Quanta Lite H-Ttg ScreenMVM · Traditional | 02/12/2008SE |
| K072632 | Quanta Plex Celiac Igg ProfileMVM · Traditional | 02/11/2008SE |
| K072967 | Quanta Lite F-Actin Iga ElisaMVM · Traditional | 01/28/2008SE |
| K063818 | Quanta Plex Celiac Iga ProfileMVM · Traditional | 06/20/2007SE |
| K070066 | Quanta Lite RNA Pol III ElisaNYO · Traditional | 04/11/2007SE |
| K063565 | Quanta Lite Ss-A 52 ElisaOBE · Traditional | 04/04/2007SE |
| K070083 | Quanta Lite H-Ttg/Dgp ScreenMST · Traditional | 03/12/2007SE |
| K061841 | Quanta Lite Intrinsic Factor ElisaLIG · Traditional | 12/22/2006SE |
| K062708 | Quanta Lite Celiac DGP ScreenMST · Traditional | 12/13/2006SE |
| K061842 | Quanta Lite PBC Screen Igg/Iga ElisaNRI · Traditional | 10/18/2006SE |
| K052264 | Quanta Lite CCP3 Igg ElisaNHX · Traditional | 11/23/2005SE |
| K052262 | Quanta Lite M2 Ep (MIT3) ElisaDBM · Traditional | 10/27/2005SE |
| K052143 | Quanta Lite Gliadin Iga IIMST · Traditional | 10/04/2005SE |
| K052142 | Quanta Lite Gliadin Igg IIMST · Traditional | 10/04/2005SE |
| K050662 | Quanta Lite SP100 ElisaNUM · Traditional | 06/13/2005SE |
| K050715 | Quanta Plex Anca ProfileMOB · Traditional | 05/12/2005SE |
| K040885 | Quanta Lite GP210 ElisaNRI · Traditional | 06/25/2004SE |
| K040160 | Quanta Plex Sle Profile 8LLL · Traditional | 03/08/2004SE |
| K031450 | Quanta Plex Ena Profile 6LLL · Traditional | 06/25/2003SE |
| K030681 | Quanta Plex Ena Profile 5LLL · Traditional | 04/24/2003SE |
| K024334 | Quanta Lite H.Pylori Iga ElisaLYR · Traditional | 03/27/2003SE |
| K021648 | Quanta Lite Actin (Anti-Smooth Muscle) ElisaNJF · Traditional | 09/20/2002SE |
| K021482 | Quanta Lite Sla (Soluble Liver Antigen) ElisaNIY · Traditional | 07/30/2002SE |
| K020414 | Quanta Lite CCP ElisaNHX · Traditional | 04/29/2002SE |
| K011140 | Quanta Plex Ena Profile 4LLL · Traditional | 07/27/2001SE |
| K011570 | Quanta Lite H-Ttg (Human Tissue Transglutaminase) Igg ElisaMVM · Traditional | 07/09/2001SE |
| K011566 | Quanta Lite H-Ttg (Human Tissue Transglutaminase) Iga ElisaMVM · Traditional | 07/09/2001SE |
| K000733 | Quanta Lite Asca (S. Cerevisiae) Iga ElisaNBT · Traditional | 05/21/2001SE |
| K010558 | Quanta Lite Gpa (Gastric Parietal Cell Antibody) ElisaMLE · Traditional | 04/03/2001SE |
| K003959 | Quanta Lite Centromere (Cenp-A & Cenp-B) ElisaLJM · Traditional | 01/22/2001SE |
| K000535 | Quanta Lite LKM-1 ElisaNBS · Traditional | 06/07/2000SE |
| K994004 | Quanta Lite Lyme B. Burgdorferi Igg/Igm Elisa KitLSR · Traditional | 01/27/2000SE |
| K991657 | Quanta Lite Ana ElisaLLL · Traditional | 06/17/1999SE |
| K984234 | Quanta Lite Lyme Igm ElisaLSR · Traditional | 04/15/1999SE |
| K984222 | Quanta Lite Lyme Igg ElisaLSR · Traditional | 04/15/1999SE |
| K984336 | Quanta Lite GBM ElisaMVJ · Traditional | 02/08/1999SE |
| K984137 | Quanta Lite Celiac Screen (Tissue Transglutaminase/Gliadin) ElisaMVM · Traditional | 01/28/1999SE |
| K983084 | Quanta Lite RF Iga ElisaDHR · Traditional | 11/04/1998SE |
| K983083 | Quanta Lite RF Igg ElisaDHR · Traditional | 11/04/1998SE |
| K982790 | Quanta Lite H. Pylori Igg ElisaLYR · Traditional | 11/04/1998SE |
| K982603 | Quanta Lite Chromatin ElisaLLL · Traditional | 10/07/1998SE |
| K982023 | Pelicalss Human Igg Subclass Nephlometric Array KitDAS · Traditional | 09/04/1998SE |
| K982366 | Quanta Lite TTG (Tissue Transglutaminase) ElisaMVM · Traditional | 08/27/1998SE |
| K981857 | Quanta Lite Tpo ElisaLLL · Traditional | 07/29/1998SE |
| K981330 | Quanta Lite Mpo Igg (Myeloperoxidase) Test KitMOB · Traditional | 06/19/1998SE |
| K981328 | Quanta Lite PR3 Igg (Serine Protease) Test KitMOB · Traditional | 06/19/1998SE |
| K981237 | Quanta Lite Ribosome P ElisaMQA · Traditional | 06/05/1998SE |
| K980312 | Nova Lite EndomysialDBL · Traditional | 04/02/1998SE |
| K980230 | Quanta Lite B2 Gpi ScreenMSV · Traditional | 03/24/1998SE |
| K971304 | Quanta Lite Rebella IggLFX · Traditional | 01/02/1998SE |
| K971441 | Quanta Lite Toxoplasma IggLGD · Traditional | 12/02/1997SE |
| K971335 | Quanta Lite CMV Igg ElisaLFZ · Traditional | 12/01/1997SE |
| K973014 | Quanta Lite B2GPI IgmMSV · Traditional | 10/20/1997SE |
| K973006 | Quanta Lite B2 Gpi IgaMSV · Traditional | 10/20/1997SE |
| K971620 | Quanta Lite Rubeola (Measles) IggLJB · Traditional | 07/22/1997SE |
| K970551 | Quanta Lite B2GPI IggMSV · Traditional | 06/24/1997SE |
| K971614 | Quanta Lite RF IgmDHR · Traditional | 06/20/1997SE |
| K964986 | Quanta Lite Iga Gliadin ElisaMST · Traditional | 06/02/1997SE |
| K964985 | Quanta Lite Igg Gliadin ElisaMST · Traditional | 05/30/1997SE |
| K961913 | Quanta Lite Ena 6 ElisaLLL · Traditional | 07/10/1996SE |
| K961340 | Nova Lite AncaMOB · Traditional | 07/10/1996SE |
| K955022 | Quanta Lite MpoMOB · Traditional | 03/19/1996SE |
| K955021 | Quanta Lite PR3MOB · Traditional | 03/19/1996SE |
| K954380 | Quanta Lite SsdnaLJM · Traditional | 02/29/1996SE |
| K953366 | Quanta Lite Iga Aca (HRP)MID · Traditional | 09/01/1995SE |
| K953291 | Quanta Lite Aca Screen (HRP)MID · Traditional | 08/29/1995SE |
| K946385 | Quanta Lite Aca Igm (HRP)MID · Traditional | 07/18/1995SE |
| K946034 | Quanta Lite(Tm) Igg (HRP)MID · Traditional | 07/18/1995SE |
| K943076 | Quanta Lite Ena 5 Elisa KitLLL · Traditional | 10/25/1994SE |
| K934053 | Quanta Lite(Tm) Histone ElisaLLL · Traditional | 12/21/1993SE |
| K933180 | Quanta Lite Mitochondria M2 ElisaDGC · Traditional | 08/05/1993SE |
| K930485 | Quanta Lite(Tm) Thyroid M ElisaJZO · Traditional | 03/16/1993SE |
| K930486 | Quanta Lite(Tm) Thyroid T ElisaDDC · Traditional | 03/15/1993SE |
| K926562 | Quanta Lite(Tm) JO-1 Elisa KitLLL · Traditional | 03/04/1993SE |
| K924898 | Quanta Lite(Tm) SCL-70 ElisaLLL · Traditional | 12/15/1992SE |
| K922351 | Quanta Lite(Tm) Iga AcaMID · Traditional | 09/29/1992SE |
| K923320 | Quanta Lite Aca ScreenMID · Traditional | 09/28/1992SE |
| K922833 | Quanta Lite RNP ElisaLLL · Traditional | 09/18/1992SE |
| K922832 | Quanta Lite Ss-B ElisaLLL · Traditional | 09/18/1992SE |
| K922831 | Quanta Lite SM ElisaLLL · Traditional | 09/18/1992SE |
| K922830 | Quanta Lite Ss-A ElisaLLL · Traditional | 09/18/1992SE |
| K922829 | Quanta Lite Ena ElisaLLL · Traditional | 09/18/1992SE |
| K911680 | Quanta Lite(Tm) AcaMID · Traditional | 11/19/1991SE |
| K904224 | Nova Lite TM ThyroidJZO · Traditional | 10/15/1990SE |
| K903898 | Quanta Lite TM DsdnaLLL · Traditional | 09/05/1990SE |
| K901596 | Nova Lite(Tm) Ana KSLDHN · Traditional | 05/02/1990SE |
| K901595 | Nova Lite(Tm) Ana MKDHN · Traditional | 04/26/1990SE |
| K896462 | Nova Gel(Tm) T JO-1LLL · Traditional | 11/20/1989SE |
| K896461 | Nova Gel(Tm) T SCL-70LLL · Traditional | 11/20/1989SE |
| K896460 | Nova Gel(Tm) T Ss-A/Ss-BLLL · Traditional | 11/20/1989SE |
| K896459 | Nova Gel(Tm) T Sm/RnpLLL · Traditional | 11/20/1989SE |
| K892897 | Nova Gel(Tm) JO-1LLL · Traditional | 05/17/1989SE |
| K881341 | Nova Lite(Tm) SALLL · Traditional | 09/22/1988SE |
| K881340 | Nova Lite(Tm) Autoantibody ControlsLLL · Traditional | 06/08/1988SE |
| K881339 | Nova Lite(Tm) Ana PlusLLL · Traditional | 04/21/1988SE |
| K880897 | Nova Gel (TM) SCL-70LLL · Traditional | 04/21/1988SE |
| K881181 | Nova Gel(Tm) Sm/RnpLLL · Traditional | 04/06/1988SE |
| K880896 | Nova Gel(Tm) Ss-A/Ss-BLLL · Traditional | 03/25/1988SE |
| K880742 | Nova Lite(Tm) DsdnaDHN · Traditional | 03/25/1988SE |
| K880736 | Nova Lite(Tm) AnaLLL · Traditional | 03/25/1988SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1222-2018 Class II | QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated…The device power supply was not manufactured according to specification which can result in the loss of the… | 01/26/2018Terminated |
| Z-1221-2018 Class II | QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated…The device power supply was not manufactured according to specification which can result in the loss of the… | 01/26/2018Terminated |
| 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)… | 09/26/2011Terminated |
| Z-1942-2010 | Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#:…The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme… | 10/28/2009Terminated |