FDA product code NPQ: Test, Factor V Leiden Mutations, Genomic Dna Pcr
NPQ is the FDA product code for test, factor v leiden mutations, genomic dna pcr. It is a Class II device, regulated under 21 CFR 864.7280 and reviewed by the Pathology panel. FDA has cleared 5 510(k) submissions under NPQ, from 5 different applicants. The average 510(k) review took 301 days (median 341). 1 De Novo request was granted under it. FDA has posted 14 recalls for NPQ devices.
Definition
In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Classification
| Field | Value |
|---|---|
| Device name | Test, Factor V Leiden Mutations, Genomic Dna Pcr |
| Device class | Class II |
| Regulation | 21 CFR 864.7280 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NPQ clearance
Top NPQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hologic, Inc. | 1 | 2011-06-01 |
| Illumina, Inc. | 1 | 2010-04-28 |
| Osmetech Molecular Diagnostics | 1 | 2010-04-22 |
| Cepheid | 1 | 2009-09-18 |
| AutoGenomics, Inc. | 1 | 2007-02-07 |
Most recent NPQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100980 | Hologic, Inc. | INVADER FACTOR V | 2011-06-01 | 419 |
| K093129 | Illumina, Inc. | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | 2010-04-28 | 208 |
| K093974 | Osmetech Molecular Diagnostics | ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING | 2010-04-22 | 120 |
| K082118 | Cepheid | XPERT HEMOSIL FACTOR II & FACTOR V ASSAY | 2009-09-18 | 417 |
| K060564 | AutoGenomics, Inc. | INFINITI SYSTEM | 2007-02-07 | 341 |
Recalls for NPQ devices
14 product recalls in 9 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-09-04.
Frequently asked questions
What is FDA product code NPQ?
NPQ is the FDA product code for test, factor v leiden mutations, genomic dna pcr. It is a Class II device, regulated under 21 CFR 864.7280 and reviewed by the Pathology panel.
What device class is NPQ?
Class II, regulation 21 CFR 864.7280. Typical premarket route: 510(k).
How long does a 510(k) take for product code NPQ?
Across 5 cleared submissions the average was 301 days from receipt to decision (median 341).
Which companies have the most NPQ clearances?
Hologic, Inc. (1); Illumina, Inc. (1); Osmetech Molecular Diagnostics (1); Cepheid (1); AutoGenomics, Inc. (1).
Have NPQ devices been recalled?
Yes: 14 product recalls across 9 recall events; the most recent began 2012-09-04.
Next steps
- Run an FDA pathway report with predicate devices for product code NPQ
- Run a recall and safety report across every NPQ manufacturer
- Watch product code NPQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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