Cleared Traditional

K152551 - First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test. (FDA 510(k) Clearance)

K152551 · W.H.P.M., Inc. · Toxicology device

Nov 2015

Decision

62d

Days

Class 2

Risk

K152551 is an FDA 510(k) clearance for the First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).

Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on November 9, 2015, 62 days after receiving the submission on September 8, 2015.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number	K152551 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 08, 2015
Decision Date	November 09, 2015
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF