FDA product code OPL: Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
OPL is the FDA product code for multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under OPL, 1 in the last five years, from 2 different applicants. The average 510(k) review took 395 days (median 299). FDA has posted 1 recall for OPL devices.
Definition
The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening blood or plasma donors.
Classification
| Field | Value |
|---|---|
| Device name | Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus |
| Device class | Class II |
| Regulation | 21 CFR 866.3510 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OPL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 759 |
Top OPL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad Laboratories | 2 | 2011-08-23 |
| Dynex Technologies, Inc. | 1 | 2023-09-29 |
Most recent OPL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212769 | Dynex Technologies, Inc. | DYNEX SmartPLEX MMRV IgG Assay Kit | 2023-09-29 | 759 |
| K111072 | Bio-Rad Laboratories | BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL | 2011-08-23 | 127 |
| K091616 | Bio-Rad Laboratories | BIOPLEX 2200 MMRV IGG | 2010-03-29 | 299 |
Recalls for OPL devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-05.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code OPL?
OPL is the FDA product code for multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is OPL?
Class II, regulation 21 CFR 866.3510. Typical premarket route: 510(k).
How long does a 510(k) take for product code OPL?
Across 3 cleared submissions the average was 395 days from receipt to decision (median 299).
Which companies have the most OPL clearances?
Bio-Rad Laboratories (2); Dynex Technologies, Inc. (1).
Have OPL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-05-05.
Next steps
- Run an FDA pathway report with predicate devices for product code OPL
- Run a recall and safety report across every OPL manufacturer
- Watch product code OPL 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.