FDA product code PAB: Cytomegalovirus (Cmv) Dna Quantitative Assay
PAB is the FDA product code for cytomegalovirus (cmv) dna quantitative assay. It is a Class II device, regulated under 21 CFR 866.3180 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under PAB, 3 in the last five years, from 3 different applicants. The average 510(k) review took 117 days (median 88); 117 days on average over the last three years. 6 PMA applications cite this product code. FDA has posted 1 recall for PAB devices, 1 initiated in the last five years.
Definition
Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Cytomegalovirus (Cmv) Dna Quantitative Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.3180 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PAB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 3 | 117 |
Compare with all 510(k) review times · Search every PAB clearance
Top PAB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Molecular Systems, Inc. | 1 | 2025-11-03 |
| Abbott Molecular, Inc. | 1 | 2025-07-01 |
| Hologic, Inc. | 1 | 2025-01-17 |
Most recent PAB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252481 | Roche Molecular Systems, Inc. | cobas CMV | 2025-11-03 | 88 |
| K243485 | Abbott Molecular, Inc. | Alinity m CMV | 2025-07-01 | 235 |
| K243935 | Hologic, Inc. | Aptima CMV Quant Assay | 2025-01-17 | 28 |
Recalls for PAB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-09-14.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code PAB?
PAB is the FDA product code for cytomegalovirus (cmv) dna quantitative assay. It is a Class II device, regulated under 21 CFR 866.3180 and reviewed by the Microbiology panel.
What device class is PAB?
Class II, regulation 21 CFR 866.3180. Typical premarket route: 510(k).
How long does a 510(k) take for product code PAB?
Across 3 cleared submissions the average was 117 days from receipt to decision (median 88).
Which companies have the most PAB clearances?
Roche Molecular Systems, Inc. (1); Abbott Molecular, Inc. (1); Hologic, Inc. (1).
Have PAB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-09-14.
Next steps
- Run an FDA pathway report with predicate devices for product code PAB
- Run a recall and safety report across every PAB manufacturer
- Watch product code PAB 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times