FDA product code NQM: Immunoassay For Detection Of Amniotic Fluid Protein(S).
NQM is the FDA product code for immunoassay for detection of amniotic fluid protein(s).. It is a Class I device, regulated under 21 CFR 862.1550 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under NQM, from 2 different applicants. The average 510(k) review took 234 days (median 234). FDA has posted 3 recalls for NQM devices.
Definition
The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.
Classification
| Field | Value |
|---|---|
| Device name | Immunoassay For Detection Of Amniotic Fluid Protein(S). |
| Device class | Class I |
| Regulation | 21 CFR 862.1550 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NQM clearance
Top NQM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clinical Innovations, LLC | 1 | 2011-11-23 |
| Amnisure International, LLC | 1 | 2009-01-09 |
Most recent NQM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110605 | Clinical Innovations, LLC | ROM PLUS | 2011-11-23 | 266 |
| K081767 | Amnisure International, LLC | AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 | 2009-01-09 | 203 |
Recalls for NQM devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-13.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 2 |
Frequently asked questions
What is FDA product code NQM?
NQM is the FDA product code for immunoassay for detection of amniotic fluid protein(s).. It is a Class I device, regulated under 21 CFR 862.1550 and reviewed by the Clinical Chemistry panel.
What device class is NQM?
Class I, regulation 21 CFR 862.1550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NQM?
Across 2 cleared submissions the average was 234 days from receipt to decision (median 234).
Which companies have the most NQM clearances?
Clinical Innovations, LLC (1); Amnisure International, LLC (1).
Have NQM devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2020-08-13.
Next steps
- Run an FDA pathway report with predicate devices for product code NQM
- Run a recall and safety report across every NQM manufacturer
- Watch product code NQM 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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