FDA product code PEU: System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
PEU is the FDA product code for system, nucleic acid-based, mycobacterium tuberculosis complex, resistance marker, direct specimen. It is a Class II device, regulated under 21 CFR 866.3373 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under PEU. The average 510(k) review took 87 days (median 87). 1 De Novo request was granted under it. FDA has posted 1 recall for PEU devices, 1 initiated in the last five years.
Definition
The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen |
| Device class | Class II |
| Regulation | 21 CFR 866.3373 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every PEU clearance
Top PEU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cepheid | 1 | 2015-02-12 |
Most recent PEU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143302 | Cepheid | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 | 2015-02-12 | 87 |
Recalls for PEU devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-05.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code PEU?
PEU is the FDA product code for system, nucleic acid-based, mycobacterium tuberculosis complex, resistance marker, direct specimen. It is a Class II device, regulated under 21 CFR 866.3373 and reviewed by the Microbiology panel.
What device class is PEU?
Class II, regulation 21 CFR 866.3373. Typical premarket route: 510(k).
How long does a 510(k) take for product code PEU?
Across 1 cleared submissions the average was 87 days from receipt to decision (median 87).
Which companies have the most PEU clearances?
Cepheid (1).
Have PEU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-05.
Next steps
- Run an FDA pathway report with predicate devices for product code PEU
- Run a recall and safety report across every PEU manufacturer
- Watch product code PEU 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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