Cleared Traditional

K871549 - RESUB. URINE COCAINE META. DIRECT RIA K...

K871549 is the FDA 510(k) clearance for RESUB. URINE COCAINE META. DIRECT RIA K... by Immunalysis Corporation. It is a Class 2 Chemistry device (product code KLN) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K871549 · Immunalysis Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
63d
Days
Class 2
Risk

K871549 is an FDA 510(k) clearance for the RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]. Classified as Radioimmunoassay, Cocaine Metabolite (product code KLN), Class II - Special Controls.

Submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on June 16, 1987 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3250 - the FDA in vitro diagnostics and chemistry 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 Immunalysis Corporation devices

Submission Details

510(k) Number K871549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1987
Decision Date June 16, 1987
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
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 Chemistry devices follow this clearance model.

Regulatory Peers - KLN Radioimmunoassay, Cocaine Metabolite

All 9
Devices cleared under the same product code (KLN) and FDA review panel - the closest regulatory comparables to K871549.
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
DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT
K862218 · Diagnostic Products Corp. · Jun 1986
ABUSCREEN RADIOIMMUNOASSAY-COCAINE META
K830480 · Hoffmann-La Roche, Inc. · Mar 1983