Cleared Traditional

K885071 - COAT-A-COUNT METHAMPHETAMIN #TKMA1

K885071 is the FDA 510(k) clearance for COAT-A-COUNT METHAMPHETAMIN #TKMA1 by Diagnostic Products Corp.. It is a Class 2 Toxicology device (product code LAF) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K885071 · Diagnostic Products Corp. · Toxicology device
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Jan 1989
Decision
32d
Days
Class 2
Risk

K885071 is an FDA 510(k) clearance for the COAT-A-COUNT METHAMPHETAMIN #TKMA1. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on January 9, 1989 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - the FDA toxicology 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K885071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1988
Decision Date January 09, 1989
Days to Decision 32 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 87d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 Toxicology devices follow this clearance model.