FDA product code PFQ: Mmp-9 Test System
PFQ is the FDA product code for mmp-9 test system. It is a Class I device, regulated under 21 CFR 862.1540 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under PFQ. The average 510(k) review took 141 days (median 141). FDA has posted 3 recalls for PFQ devices, 2 initiated in the last five years.
Definition
A visual, qualitative immunoassay for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye.
Classification
| Field | Value |
|---|---|
| Device name | Mmp-9 Test System |
| Device class | Class I |
| Regulation | 21 CFR 862.1540 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PFQ clearance
Top PFQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rapid Pathogen Screening, Inc. | 1 | 2013-11-21 |
Most recent PFQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132066 | Rapid Pathogen Screening, Inc. | INFLAMMA DRY | 2013-11-21 | 141 |
Recalls for PFQ devices
3 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-03-05.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code PFQ?
PFQ is the FDA product code for mmp-9 test system. It is a Class I device, regulated under 21 CFR 862.1540 and reviewed by the Clinical Chemistry panel.
What device class is PFQ?
Class I, regulation 21 CFR 862.1540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PFQ?
Across 1 cleared submissions the average was 141 days from receipt to decision (median 141).
Which companies have the most PFQ clearances?
Rapid Pathogen Screening, Inc. (1).
Have PFQ devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2024-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code PFQ
- Run a recall and safety report across every PFQ manufacturer
- Watch product code PFQ 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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