FDA product code PCL: Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
PCL is the FDA product code for enzyme linked immunoabsorbent assay, rubeola igm. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under PCL. The average 510(k) review took 87 days (median 87). FDA has posted 3 recalls for PCL devices, 1 initiated in the last five years.
Definition
The qualitative detection of measles specific IgM antibodies in serum or plasma.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Rubeola Igm |
| Device class | Class I |
| Regulation | 21 CFR 866.3520 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PCL clearance
Top PCL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Trinity Biotech USA | 1 | 2014-05-22 |
Most recent PCL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140455 | Trinity Biotech USA | CAPTIA MEASLES IGM | 2014-05-22 | 87 |
Recalls for PCL devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-07-17.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code PCL?
PCL is the FDA product code for enzyme linked immunoabsorbent assay, rubeola igm. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel.
What device class is PCL?
Class I, regulation 21 CFR 866.3520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PCL?
Across 1 cleared submissions the average was 87 days from receipt to decision (median 87).
Which companies have the most PCL clearances?
Trinity Biotech USA (1).
Have PCL devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-07-17.
Next steps
- Run an FDA pathway report with predicate devices for product code PCL
- Run a recall and safety report across every PCL manufacturer
- Watch product code PCL 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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