Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Inova Diagnostics, Inc. — Predicate Candidate Screening
138 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
275 days90th percentile
138clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | 2026-02-06 | 410 | 0 |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | 2024-12-17 | 809 | 0 |
| K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023-09-29 | 711 | 0 |
| K200230 | Aptiva Celiac Disease IgG Reagent | Inova Diagnostics, Inc. | 2021-08-26 | 574 | 0 |
| K193604 | Aptiva Celiac Disease IgA Reagent | Inova Diagnostics, Inc. | 2021-06-16 | 541 | 0 |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | Inova Diagnostics, Inc. | 2020-12-11 | 423 | 0 |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | Inova Diagnostics, Inc. | 2019-04-17 | 90 | 0 |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | Inova Diagnostics, Inc. | 2018-10-16 | 186 | 0 |
| K180975 | QUANTA Flash HMGCR Reagents | Inova Diagnostics, Inc. | 2018-06-25 | 73 | 0 |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotecti | Inova Diagnostics, Inc. | 2017-12-22 | 263 | 0 |
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrator | Inova Diagnostics, Inc. | 2017-09-06 | 264 | 0 |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, | Inova Diagnostics, Inc. | 2017-09-05 | 264 | 0 |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formali | Inova Diagnostics, Inc. | 2017-02-03 | 275 | 0 |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA | Inova Diagnostics, Inc. | 2016-06-01 | 260 | 0 |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANT | Inova Diagnostics, Inc. | 2016-04-11 | 265 | 0 |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA | Inova Diagnostics, Inc. | 2016-02-12 | 260 | 0 |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Contr | Inova Diagnostics, Inc. | 2015-12-21 | 82 | 0 |
| K153150 | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 | Inova Diagnostics, Inc. | 2015-11-24 | 22 | 0 |
| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA | Inova Diagnostics, Inc. | 2015-09-21 | 264 | 0 |
| DEN140039 | NOVA View Automated Fluorescense Microscope | Inova Diagnostics, Inc. | 2015-04-09 | 115 | 0 |
| K150155 | NOVA Lite DAPI ANA Kit | Inova Diagnostics, Inc. | 2015-04-08 | 75 | 0 |
| K141655 | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA | Inova Diagnostics, Inc. | 2015-03-05 | 258 | 0 |
| K141274 | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿ | Inova Diagnostics, Inc. | 2015-02-13 | 273 | 0 |
| K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLA | Inova Diagnostics, Inc. | 2015-02-12 | 267 | 0 |
| K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA | Inova Diagnostics, Inc. | 2015-01-29 | 265 | 0 |
| K123880 | QUANTA FLASH CENTROMERE | Inova Diagnostics, Inc. | 2014-02-07 | 417 | 0 |
| K122923 | QUANTA FLASH ENA7 | Inova Diagnostics, Inc. | 2013-05-07 | 225 | 0 |
| K123593 | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATO | Inova Diagnostics, Inc. | 2013-04-17 | 147 | 0 |
| K120817 | QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA | Inova Diagnostics, Inc. | 2013-02-26 | 344 | 0 |
| K113863 | QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP | Inova Diagnostics, Inc. | 2012-09-20 | 265 | 0 |
| K112545 | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM | Inova Diagnostics, Inc. | 2012-07-31 | 334 | 0 |
| K111414 | QUANTA FLASH (TM) DGP SCREEN | Inova Diagnostics, Inc. | 2011-10-20 | 153 | 0 |
| K101644 | QUANTA FLASH H-TTG IGG | Inova Diagnostics, Inc. | 2011-03-23 | 286 | 0 |
| K094060 | QUANTA FLASH H-TTG IGA | Inova Diagnostics, Inc. | 2010-10-13 | 286 | 0 |
| K090755 | QUANTA LITE APS/PT IGG AND IGM ELISA | Inova Diagnostics, Inc. | 2010-02-01 | 318 | 0 |
| K081248 | QUANTA LITE OMP PLUS ELISA | Inova Diagnostics, Inc. | 2008-10-27 | 178 | 0 |
| K072944 | QUANTA LITE CCP3.1 IGG/IGA ELISA | Inova Diagnostics, Inc. | 2008-03-05 | 140 | 0 |
| K073145 | QUANTA LITE H-TTG SCREEN | Inova Diagnostics, Inc. | 2008-02-12 | 96 | 0 |
| K072632 | QUANTA PLEX CELIAC IGG PROFILE | Inova Diagnostics, Inc. | 2008-02-11 | 146 | 0 |
| K072967 | QUANTA LITE F-ACTIN IGA ELISA | Inova Diagnostics, Inc. | 2008-01-28 | 98 | 0 |
| K063818 | QUANTA PLEX CELIAC IGA PROFILE | Inova Diagnostics, Inc. | 2007-06-20 | 180 | 0 |
| K070066 | QUANTA LITE RNA POL III ELISA | Inova Diagnostics, Inc. | 2007-04-11 | 93 | 0 |
| K063565 | QUANTA LITE SS-A 52 ELISA | Inova Diagnostics, Inc. | 2007-04-04 | 127 | 0 |
| K070083 | QUANTA LITE H-TTG/DGP SCREEN | Inova Diagnostics, Inc. | 2007-03-12 | 62 | 0 |
| K061841 | QUANTA LITE INTRINSIC FACTOR ELISA | Inova Diagnostics, Inc. | 2006-12-22 | 176 | 0 |
| K062708 | QUANTA LITE CELIAC DGP SCREEN | Inova Diagnostics, Inc. | 2006-12-13 | 93 | 0 |
| K061842 | QUANTA LITE PBC SCREEN IGG/IGA ELISA | Inova Diagnostics, Inc. | 2006-10-18 | 111 | 0 |
| K052264 | QUANTA LITE CCP3 IGG ELISA | Inova Diagnostics, Inc. | 2005-11-23 | 96 | 0 |
| K052262 | QUANTA LITE M2 EP (MIT3) ELISA | Inova Diagnostics, Inc. | 2005-10-27 | 69 | 0 |
| K052143 | QUANTA LITE GLIADIN IGA II | Inova Diagnostics, Inc. | 2005-10-04 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda