Inova Diagnostics, Inc.: FDA clearances and approvals
Inova Diagnostics, Inc. has 136 FDA 510(k) clearances (first 1988, latest 2026), plus 2 De Novo decisions, across 41 product codes in 3 review panels. Median 510(k) review time: 93 days. Since 2017 its median was 275 days, against 194 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 300 |
| 2013 | 3 | 225 |
| 2014 | 1 | 417 |
| 2015 | 8 | 261 |
| 2016 | 3 | 260 |
| 2017 | 4 | 264 |
| 2018 | 2 | 130 |
| 2019 | 1 | 90 |
| 2020 | 1 | 423 |
| 2021 | 2 | 558 |
| 2022 | 0 | — |
| 2023 | 1 | 711 |
| 2024 | 1 | 809 |
| 2025 | 0 | — |
| 2026 | 1 | 410 |
Review time against the same product codes
Since 2017, Inova Diagnostics, Inc.'s cleared 510(k)s took a median 275 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 194 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 37 | 37 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 12 | 12 |
| MID | System, Test, Anticardiolipin Immunological | 9 | 9 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 8 | 8 |
| MST | Antibodies, Gliadin | 8 | 8 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 7 | 7 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 4 | 4 |
| DHR | System, Test, Rheumatoid Factor | 4 | 4 |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 4 | 4 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 3 | 3 |
Plus 31 more product codes.
Review panels
- Immunology (128)
- Microbiology (9)
- Clinical Chemistry (1)
Most recent Inova Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243979 | Aptiva APS IgA Reagent | MSV | 2026-02-06 | 410 |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | MID | 2024-12-17 | 809 |
| K213403 | Aptiva CTD Essential Reagent | LLL | 2023-09-29 | 711 |
| K200230 | Aptiva Celiac Disease IgG Reagent | MVM | 2021-08-26 | 574 |
| K193604 | Aptiva Celiac Disease IgA Reagent | MVM | 2021-06-16 | 541 |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | KTL | 2020-12-11 | 423 |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | DHR | 2019-04-17 | 90 |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | NXO | 2018-10-16 | 186 |
| K180975 | QUANTA Flash HMGCR Reagents | LLL | 2018-06-25 | 73 |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | NXO | 2017-12-22 | 263 |
126 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140039 | De Novo | Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | 2015-04-09 |
| DEN000007 | De Novo | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | 2000-08-16 |
Recalls
openFDA lists no recalls under a recalling firm named Inova Diagnostics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Inova Diagnostics, Inc. have?
Inova Diagnostics, Inc. has 136 FDA 510(k) clearances (first 1988, latest 2026), plus 2 De Novo decisions, across 41 product codes in 3 review panels.
How long does FDA take to clear Inova Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Inova Diagnostics, Inc.'s cleared 510(k)s is 93 days. Since 2017: 275 days, versus 194 days for all cleared 510(k)s in the same product codes.
What devices does Inova Diagnostics, Inc. make?
Its most frequent FDA product codes are LLL (Extractable Antinuclear Antibody, Antigen And Control, 37); MVM (Autoantibodies, Endomysial(Tissue Transglutaminase), 12); MID (System, Test, Anticardiolipin Immunological, 9).
Has Inova Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Inova Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 136 Inova Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLL, Inova Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.