Cleared Traditional

TARGET COCAINE METABOLITE-R (K910122) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910122 · V-Tech, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
67d
Days
Class 2
Risk

K910122 is an FDA 510(k) clearance for the TARGET COCAINE METABOLITE-R. Classified as Radioimmunoassay, Cocaine Metabolite (product code KLN), Class II - Special Controls.

Submitted by V-Tech, Inc. (El Monte, US). The FDA issued a Cleared decision on March 19, 1991 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3250 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all V-Tech, Inc. devices

Submission Details

510(k) Number K910122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1991
Decision Date March 19, 1991
Days to Decision 67 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 104d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLN Radioimmunoassay, Cocaine Metabolite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - KLN Radioimmunoassay, Cocaine Metabolite

All 13
Devices cleared under the same product code (KLN) and FDA review panel - the closest regulatory comparables to K910122.
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
K913722 · Roche Diagnostic Systems, Inc. · Sep 1991
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE
K912756 · Roche Diagnostic Systems, Inc. · Jul 1991
MILENIA COCAINE METABOLITE
K910044 · Diagnostic Products Corp. · Feb 1991
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
K905730 · Roche Diagnostic Systems, Inc. · Jan 1991
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
K904995 · Roche Diagnostic Systems, Inc. · Nov 1990
COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5
K870740 · Diagnostic Products Corp. · Mar 1987