FDA product code PTH: Test, Barbiturate, Over The Counter
PTH is the FDA product code for test, barbiturate, over the counter. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under PTH. The average 510(k) review took 29 days (median 29).
Definition
The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine.
Classification
| Field | Value |
|---|---|
| Device name | Test, Barbiturate, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.3150 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PTH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 29 |
Compare with all 510(k) review times · Search every PTH clearance
Top PTH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hangzhou Clongene Biotech Co., Ltd. | 1 | 2018-02-28 |
Most recent PTH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180255 | Hangzhou Clongene Biotech Co., Ltd. | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | 2018-02-28 | 29 |
Recalls for PTH devices
openFDA lists no recalls for product code PTH.
Frequently asked questions
What is FDA product code PTH?
PTH is the FDA product code for test, barbiturate, over the counter. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel.
What device class is PTH?
Class II, regulation 21 CFR 862.3150. Typical premarket route: 510(k).
How long does a 510(k) take for product code PTH?
Across 1 cleared submissions the average was 29 days from receipt to decision (median 29).
Which companies have the most PTH clearances?
Hangzhou Clongene Biotech Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PTH
- Run a recall and safety report across every PTH manufacturer
- Watch product code PTH 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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