FDA product code OYP: Anti-Jcv Antibody Detection Assay
OYP is the FDA product code for anti-jcv antibody detection assay. It is a Class II device, regulated under 21 CFR 866.3336 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under OYP. The average 510(k) review took 136 days (median 136). 1 De Novo request was granted under it. FDA has posted 1 recall for OYP devices.
Definition
The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory therapies.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Jcv Antibody Detection Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.3336 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OYP clearance
Top OYP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Focus Diagnostics, Inc. | 1 | 2012-08-16 |
Most recent OYP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120986 | Focus Diagnostics, Inc. | STRATIFY JCV DXSELECT | 2012-08-16 | 136 |
Recalls for OYP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-03-15.
Frequently asked questions
What is FDA product code OYP?
OYP is the FDA product code for anti-jcv antibody detection assay. It is a Class II device, regulated under 21 CFR 866.3336 and reviewed by the Microbiology panel.
What device class is OYP?
Class II, regulation 21 CFR 866.3336. Typical premarket route: 510(k).
How long does a 510(k) take for product code OYP?
Across 1 cleared submissions the average was 136 days from receipt to decision (median 136).
Which companies have the most OYP clearances?
Focus Diagnostics, Inc. (1).
Have OYP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-03-15.
Next steps
- Run an FDA pathway report with predicate devices for product code OYP
- Run a recall and safety report across every OYP manufacturer
- Watch product code OYP 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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