FDA product code PHJ: System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
PHJ is the FDA product code for system, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations. It is a Class II device, regulated under 21 CFR 864.7280 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under PHJ. The average 510(k) review took 263 days (median 263).
Definition
A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in diagnosis of patients with suspected thrombophilia.
Classification
| Field | Value |
|---|---|
| Device name | System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations |
| 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 PHJ clearance
Top PHJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sequenom, Inc. | 1 | 2014-06-13 |
Most recent PHJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132978 | Sequenom, Inc. | IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST | 2014-06-13 | 263 |
Recalls for PHJ devices
openFDA lists no recalls for product code PHJ.
Frequently asked questions
What is FDA product code PHJ?
PHJ is the FDA product code for system, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations. It is a Class II device, regulated under 21 CFR 864.7280 and reviewed by the Pathology panel.
What device class is PHJ?
Class II, regulation 21 CFR 864.7280. Typical premarket route: 510(k).
How long does a 510(k) take for product code PHJ?
Across 1 cleared submissions the average was 263 days from receipt to decision (median 263).
Which companies have the most PHJ clearances?
Sequenom, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PHJ
- Run a recall and safety report across every PHJ manufacturer
- Watch product code PHJ 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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