FDA product code NPR: Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
NPR is the FDA product code for test, factor ii g20210a 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 NPR, 2 in the last five years, from 5 different applicants. The average 510(k) review took 146 days (median 109); 28 days on average over the last three years. FDA has posted 2 recalls for NPR devices.
Definition
In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Classification
| Field | Value |
|---|---|
| Device name | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr |
| Device class | Class II |
| Regulation | 21 CFR 864.7280 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
510(k) clearances per year for NPR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 109 |
| 2023 | 1 | 139 |
| 2025 | 1 | 28 |
Compare with all 510(k) review times · Search every NPR clearance
Top NPR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cepheid | 1 | 2025-02-21 |
| Cepheid® | 1 | 2023-02-15 |
| Roche Molecular Systems, Inc. | 1 | 2018-01-12 |
| Hologic, Inc. | 1 | 2011-06-02 |
| Roche Diagnostics Corp. | 1 | 2003-12-18 |
Most recent NPR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250218 | Cepheid | Xpert® FII & FV | 2025-02-21 | 28 |
| K223046 | Cepheid® | Xpert® FII & FV | 2023-02-15 | 139 |
| K172913 | Roche Molecular Systems, Inc. | cobas Factor II and Factor V Test | 2018-01-12 | 109 |
| K100943 | Hologic, Inc. | INVADER FACTOR II | 2011-06-02 | 422 |
| K033612 | Roche Diagnostics Corp. | FACTOR II (PROTHROMBIN) G20210A KIT | 2003-12-18 | 31 |
Recalls for NPR devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-10-26.
Frequently asked questions
What is FDA product code NPR?
NPR is the FDA product code for test, factor ii g20210a 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 NPR?
Class II, regulation 21 CFR 864.7280. Typical premarket route: 510(k).
How long does a 510(k) take for product code NPR?
Across 5 cleared submissions the average was 146 days from receipt to decision (median 109).
Which companies have the most NPR clearances?
Cepheid (1); Cepheid® (1); Roche Molecular Systems, Inc. (1); Hologic, Inc. (1); Roche Diagnostics Corp. (1).
Have NPR devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2010-10-26.
Next steps
- Run an FDA pathway report with predicate devices for product code NPR
- Run a recall and safety report across every NPR manufacturer
- Watch product code NPR 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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