Cleared Traditional

K910043 - TENONE(TM) METHAMPHETAMINE

K910043 is the FDA 510(k) clearance for TENONE(TM) METHAMPHETAMINE by Diagnostic Products Corp.. It is a Class 2 Toxicology device (product code LAF) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K910043 · Diagnostic Products Corp. · Toxicology device
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Feb 1991
Decision
41d
Days
Class 2
Risk

K910043 is an FDA 510(k) clearance for the TENONE(TM) METHAMPHETAMINE. 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 February 14, 1991 after a review of 41 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 K910043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1991
Decision Date February 14, 1991
Days to Decision 41 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
46d faster than avg
Panel avg: 87d · This submission: 41d
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.

Regulatory Peers - LAF Gas Chromatography, Methamphetamine

All 28
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K910043.
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K885071 · Diagnostic Products Corp. · Jan 1989