Cleared Traditional

ACCUSIGN MET/BIOSIGN MET (K961249) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961249 · Princeton BioMeditech Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
24d
Days
Class 2
Risk

K961249 is an FDA 510(k) clearance for the ACCUSIGN MET/BIOSIGN MET. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on April 25, 1996 after a review of 24 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 Princeton BioMeditech Corp. devices

Submission Details

510(k) Number K961249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1996
Decision Date April 25, 1996
Days to Decision 24 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 87d · This submission: 24d
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 13
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K961249.
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096 · Roche Diagnostics Corp. · Apr 2000
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982 · Syva Co. · Jan 2000
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
K992634 · Diagnostic Products Corp. · Jan 2000
TENONE(TM) METHAMPHETAMINE
K910043 · Diagnostic Products Corp. · Feb 1991
COAT-A-COUNT METHAMPHETAMIN #TKMA1
K885071 · Diagnostic Products Corp. · Jan 1989