Device product
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.
Z-1438-2020
Product summary
- Event
- Event 84840
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6790
- Official record key
device-enforcement:Z-1438-2020
Official wording
Reason: The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Code information: 1811715 1831313 1831324 1831325
Distribution pattern: Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.
Derived failure modes
-
Unknown
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.