510(k) Report

FDA applicant

Inova Diagnostics, Inc.

San Diego, CA138 decisions1988–20261 recall

FDA records 138 decisions for Inova Diagnostics, Inc. (San Diego, CA) from 1988 to 2026: 136 510(k) clearances and 2 De Novo grants. Most are in product codes LLL (Extractable Antinuclear Antibody, Antigen And…) and MVM (Autoantibodies, Endomysial (Tissue…). Its devices cite 42 predicates, 35 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Inova Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 42008: 52010: 22011: 22012: 22013: 32014: 12015: 92016: 32017: 42018: 22019: 12020: 12021: 22023: 12024: 12026 (partial year): 1
2007high 9 (2015) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Inova Diagnostics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Inova Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LLLExtractable Antinuclear Antibody, Antigen And Control37decisions
  • MVMAutoantibodies, Endomysial (Tissue Transglutaminase)12decisions
  • MIDSystem, Test, Anticardiolipin Immunological9decisions
  • MSTAntibodies, Gliadin8decisions
  • MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)8decisions
  • MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)7decisions

Also: DHN (4), NHX (4), DHR (4), LSR (3), LJM (3), NXO (2).

Whose devices does it build on?

Its devices cite 42 predicates; 35 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 103 times; 35 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K981237Quanta Lite Ribosome P ElisaInova Diagnostics, Inc. · 19985cite it
  • K052143Quanta Lite Gliadin Iga IIInova Diagnostics, Inc. · 20054cite it
  • K961340Nova Lite AncaInova Diagnostics, Inc. · 19964cite it
  • K052142Quanta Lite Gliadin Igg IIInova Diagnostics, Inc. · 20054cite it
  • K970551Quanta Lite B2GPI IggInova Diagnostics, Inc. · 19974cite it
  • K052262Quanta Lite M2 EP (MIT3) ElisaInova Diagnostics, Inc. · 20054cite it

What has FDA decided for it lately?

  • K243979Aptiva APS IgA ReagentInova Diagnostics, Inc. · 2026
  • K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc. · 2024
  • K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
  • K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc. · 2021
  • K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc. · 2021
  • K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc. · 2020
  • K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc. · 2019
  • K180971QUANTA Flash Calprotectin and Fecal Extraction DeviceInova Diagnostics, Inc. · 2018

All 138 as Inova Diagnostics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K901596Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.Sep 26, 2011

Other applicant names beginning “Inova”

FDA records each applicant name separately; these may or may not be the same firm.

Inova Labs, Inc. 3