510(k) Report

FDA applicant

Autogenomics, Incorporated

Carlsbad, CA4 decisions2007–20230 recalls

FDA records 4 decisions for Autogenomics, Incorporated (Carlsbad, CA) from 2007 to 2023: 3 510(k) clearances and 1 original PMA approval. Most are in product codes NTI (Drug Metabolizing Enzyme Genotyping Systems) and NPQ (Test, Factor V Leiden Mutations, Genomic Dna Pcr). Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “AutoGenomics, Inc.”.

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

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Autogenomics, Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 12008: 12010: 12023: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • NTIDrug Metabolizing Enzyme Genotyping Systems1decision
  • NPQTest, Factor V Leiden Mutations, Genomic Dna Pcr1decision
  • ODWCytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System1decision
  • QZHOpioid Use Disorder Genetic Risk Variant Detection System And Collection Kit1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K060564Infiniti SystemAutoGenomics, Inc. · 20074cite it
  • K101683Infiniti CYP2C19 AssayAutogenomics, Incorporated · 20102cite it
  • K073014Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated · 20081cites it

What has FDA decided for it lately?

  • P230032AvertD and AvertD Buccal Sample Collection KitAutoGenomics, Inc. · 2023
  • K101683Infiniti CYP2C19 AssayAutogenomics, Incorporated · 2010
  • K073014Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated · 2008
  • K060564Infiniti SystemAutoGenomics, Inc. · 2007

All 2 as Autogenomics, Incorporated →All 2 as AutoGenomics, Inc. →