FDA product code OAM: Immunoassay, Insulin-Like Growth Factor Binding Protein-1
OAM is the FDA product code for immunoassay, insulin-like growth factor binding protein-1. 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 OAM, from 2 different applicants. The average 510(k) review took 292 days (median 292). FDA has posted 1 recall for OAM devices, 1 initiated in the last five years.
Definition
The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.
Classification
| Field | Value |
|---|---|
| Device name | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 |
| 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 OAM clearance
Top OAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alere Scarborough, Inc. | 1 | 2014-01-09 |
| Medix Biochemica | 1 | 2007-01-25 |
Most recent OAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123986 | Alere Scarborough, Inc. | ACTIM PROM | 2014-01-09 | 379 |
| K061886 | Medix Biochemica | ACTIM PROM AND CONTROLS | 2007-01-25 | 206 |
Recalls for OAM devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-11-23.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code OAM?
OAM is the FDA product code for immunoassay, insulin-like growth factor binding protein-1. It is a Class I device, regulated under 21 CFR 862.1550 and reviewed by the Clinical Chemistry panel.
What device class is OAM?
Class I, regulation 21 CFR 862.1550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OAM?
Across 2 cleared submissions the average was 292 days from receipt to decision (median 292).
Which companies have the most OAM clearances?
Alere Scarborough, Inc. (1); Medix Biochemica (1).
Have OAM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-11-23.
Next steps
- Run an FDA pathway report with predicate devices for product code OAM
- Run a recall and safety report across every OAM manufacturer
- Watch product code OAM 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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