Cleared Traditional

K992634 - IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5

K992634 is an FDA 510(k) clearance for IMMULITE METHAMPHETAMINE, manufactured by Diagnostic Products Corp.. The device is a Class 2 Toxicology device with product code LAF cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K992634 · Diagnostic Products Corp. · Toxicology device
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Jan 2000
Decision
167d
Days
Class 2
Risk

K992634 is an FDA 510(k) clearance for the IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5. 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 20, 2000 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K992634

510(k) Number K992634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1999
Decision Date January 20, 2000
Days to Decision 167 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 87d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAF Device Classification - Class 2, Special Controls

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 37
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K992634.
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
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