Cleared Traditional

K972556 - QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)

K972556 is an FDA 510(k) clearance for QUICKSCREEN ONE STEP METHAMPHETAMINE TE..., manufactured by Phamatech. The device is a Class 2 Toxicology device with product code LAF cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K972556 · Phamatech · Toxicology device
Download Printable Device Report (PDF)
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Sep 1997
Decision
55d
Days
Class 2
Risk

K972556 is an FDA 510(k) clearance for the QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065). Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Phamatech (Sandiego, US). The FDA issued a Cleared decision on September 2, 1997 after a review of 55 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 Phamatech devices

FDA 510(k) Submission Details - K972556

510(k) Number K972556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1997
Decision Date September 02, 1997
Days to Decision 55 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
32d faster than avg
Panel avg: 87d · This submission: 55d
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 39
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K972556.
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K910043 · Diagnostic Products Corp. · Feb 1991
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K904413 · Microgenics Corp. · Nov 1990