PROGENSA PCA3 ASSAY
FDA premarket approval P100033 · decided 2012-02-13
Approval details
- PMA number
- P100033
- Trade name
- PROGENSA PCA3 ASSAY
- Generic name
- Prostrate cancer genes nucleic acid amplification test system
- Applicant
- Gen-Probe Incorporated
- Date received
- 2010-08-10
- Decision date
- 2012-02-13
- Days to decision
- 552 days
- Decision code
- APWD
- Product code
- OYM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE PROGENSA PCA3 ASSAY. THIS DEVICE IS INDICATED FOR: PROGENSA PCA3 ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST. THE ASSAY MEASURES THE CONCENTRATION OF PROSTATE CANCER GENE 3 (PCA3) AND PROSTATE-SPECIFIC ANTIGEN (PSA) RNA (RNA) MOLECULES AND CALCULATES THE RATIO OF PCA3 RNA MOLECULES TO PSA RNA MOLECULES (PCA3 SCORE) IN POST DIGITAL RECTAL EXAM (DRE) FIRST CATCH MALE URINE SPECIMENS. THE PROGENSA PCA3 ASSAY IS INDICATED FOR USE IN CONJUNCTION WITH OTHER PATIENT INFORMATIO
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |