Gen-Probe, Inc.: FDA filings under this applicant name
FDA lists 62 510(k) clearances under 3 spellings of the applicant name “Gen-Probe, Inc.” (first 1985, latest 2013), plus 5 PMA and 1 De Novo decisions, across 26 product codes in 3 review panels. Median 510(k) review time under this name: 112 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Hologic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 350 |
| 2013 | 1 | 180 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LSL | Dna-Reagents, Neisseria | 15 | 15 |
| LQF | Dna-Reagents, Mycobacterium Spp. | 13 | 13 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | 5 | 5 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 4 | 4 |
| LSK | Dna-Reagents, Chlamydia | 4 | 4 |
| MDK | Dna-Probe, Reagents, Streptococcal | 3 | 3 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 2 | 2 |
| MCC | Dna-Probe, Haemophilus Spp. | 2 | 2 |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | 2 | 1 |
| OYB | Kit, Rna Detection, Human Papillomavirus | 2 | 0 |
Plus 16 more product codes.
Review panels
- Microbiology (63)
- Clinical Chemistry (4)
- Immunology (1)
Most recent Gen-Probe, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122062 | APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER | OUY | 2013-01-09 | 180 |
| K111409 | APTIMA COMBO 2 ASSAY | LSL | 2012-05-03 | 350 |
| K063664 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 | LSL | 2007-01-25 | 48 |
| K063451 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 | MKZ | 2007-01-22 | 68 |
| K062440 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 | LSL | 2006-11-07 | 78 |
| K061413 | APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM | MKZ | 2006-10-13 | 144 |
| K061509 | TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 | LSL | 2006-10-04 | 125 |
| K060652 | TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY | LSL | 2006-08-17 | 157 |
| K053446 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 | MKZ | 2006-07-25 | 225 |
| K043224 | GEN-PROBE APTIMA COMBO 2 ASSAY | LSL | 2005-08-09 | 260 |
52 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P120007 | PMA | APTIMA HPV 16 18/45 GENOTYPE ASSAY | 2012-10-12 |
| P100033 | PMA | PROGENSA PCA3 ASSAY | 2012-02-13 |
| P100042 | PMA | APTIMA HPV ASSAY | 2011-10-28 |
| DEN110012 | De Novo | Trichomonas Vaginalis Nucleic Acid Amplification Test System | 2011-04-19 |
| P020011 | PMA | VERSANT HCV RNA QUALITATIVE ASSAY | 2002-11-07 |
Recalls
6 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2014-04-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Gen-Probe, Inc. is the lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01702272: Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - CTS (Completed, started 2013-01)
- NCT01694875: Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System (Completed, started 2012-10)
- NCT01656174: Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross (Completed, started 2012-08)
- NCT01427023: Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing (Completed, started 2012-08)
- NCT01638637: Prospective Collection of Female and Male Specimens for PANTHER® System Testing (Completed, started 2012-02)
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Gen-Probe, Inc. (63)
- Gen-Probe Incorporated (4)
- Gen-Probe (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gen-Probe, Inc.?
FDA lists 62 510(k) clearances under 3 spellings of the applicant name “Gen-Probe, Inc.” (first 1985, latest 2013), plus 5 PMA and 1 De Novo decisions, across 26 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gen-Probe, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gen-Probe, Inc. is 112 days.
Which FDA product codes appear under Gen-Probe, Inc.?
The most frequent FDA product codes under this applicant name are LSL (Dna-Reagents, Neisseria, 15); LQF (Dna-Reagents, Mycobacterium Spp., 13); MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia, 5).
Next steps
- See all 62 Gen-Probe, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LSL, Gen-Probe, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.