FDA product code PIT: Leishmania Spp. Antigen Detection Assay
PIT is the FDA product code for leishmania spp. antigen detection assay. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under PIT. The average 510(k) review took 177 days (median 177).
Definition
An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.
Classification
| Field | Value |
|---|---|
| Device name | Leishmania Spp. Antigen Detection Assay |
| Device class | Class I |
| Regulation | 21 CFR 866.3870 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PIT clearance
Top PIT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| InBios International, Inc. | 1 | 2014-11-14 |
Most recent PIT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141341 | InBios International, Inc. | CL DETECT RAPID TEST | 2014-11-14 | 177 |
Recalls for PIT devices
openFDA lists no recalls for product code PIT.
Frequently asked questions
What is FDA product code PIT?
PIT is the FDA product code for leishmania spp. antigen detection assay. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel.
What device class is PIT?
Class I, regulation 21 CFR 866.3870. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIT?
Across 1 cleared submissions the average was 177 days from receipt to decision (median 177).
Which companies have the most PIT clearances?
InBios International, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PIT
- Run a recall and safety report across every PIT manufacturer
- Watch product code PIT 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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