510(k) Report

FDA applicant

Gen-Probe, Inc.

San Diego, CA68 decisions1985–20134 recalls

FDA records 68 decisions for Gen-Probe, Inc. (San Diego, CA) from 1985 to 2013: 62 510(k) clearances, 1 De Novo grant and 5 original PMA approvals. Most are in product codes LSL (Dna-Reagents, Neisseria) and LQF (Dna-Reagents, Mycobacterium Spp.). Its devices cite 5 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Gen-Probe Incorporated”, “Gen-Probe”.

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

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

How often FDA has decided Gen-Probe, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 22011: 22012: 32013: 1
2007high 3 (2012) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2008: 22014: 12026 (partial year): 1
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Gen-Probe, 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?

  • LSLDna-Reagents, Neisseria15decisions
  • LQFDna-Reagents, Mycobacterium Spp.13decisions
  • MKZDna Probe, Nucleic Acid Amplification, Chlamydia5decisions
  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use4decisions
  • LSKDna-Reagents, Chlamydia4decisions
  • MDKDna-Probe, Reagents, Streptococcal3decisions

Also: OYB (2), GTZ (2), OUY (2), MCC (2), JXA (1), MDC (1).

Whose devices does it build on?

Its devices cite 5 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 4 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.

  • K122062Aptima Trichomonas Vaginalis Assay - PantherGen-Probe, Inc. · 20135cite it
  • K043144Gen-Probe Aptima Assay for Neisseria GonorrhoeaeGen-Probe, Inc. · 20054cite it
  • K003395Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 20014cite it
  • DEN110012Aptima Trichomonas Vaginalis AssayGen-Probe Incorporated · 20114cite it
  • K043224Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 20053cite it
  • K062440Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091Gen-Probe, Inc. · 20063cite it

What has FDA decided for it lately?

  • K122062Aptima Trichomonas Vaginalis Assay - PantherGen-Probe, Inc. · 2013
  • P120007Aptima HPV 16 18/45 Genotype AssayGen-Probe Incorporated · 2012
  • K111409Aptima Combo 2 AssayGen-Probe, Inc. · 2012
  • P100033Progensa PCA3 AssayGen-Probe Incorporated · 2012
  • P100042Aptima HPV AssayGen-Probe Incorporated · 20111 recall
  • DEN110012Aptima Trichomonas Vaginalis AssayGen-Probe Incorporated · 2011
  • K063664Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Model#1091Gen-Probe, Inc. · 2007
  • K063451Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199Gen-Probe, Inc. · 2007

All 63 as Gen-Probe, Inc. →All 4 as Gen-Probe Incorporated →The one decision as Gen-Probe →

What has been recalled?

4 recalls linked to its devices; the latest:

  • P100042Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585…Feb 18, 2026Class II
  • K003395APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234.…Apr 17, 2014Class III
  • K921435Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.Dec 30, 2008
  • K896493Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.Dec 30, 2008