Cleared Traditional

K012131 - LIVESURE BENZODIAZEPINES SCREEN TESTS

K012131 is the FDA 510(k) clearance for LIVESURE BENZODIAZEPINES SCREEN TESTS by Pan Probe Biotech, Inc.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K012131 · Pan Probe Biotech, Inc. · Toxicology device
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Jul 2001
Decision
11d
Days
Class 2
Risk

K012131 is an FDA 510(k) clearance for the LIVESURE BENZODIAZEPINES SCREEN TESTS. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Pan Probe Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 20, 2001 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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 Pan Probe Biotech, Inc. devices

Submission Details

510(k) Number K012131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2001
Decision Date July 20, 2001
Days to Decision 11 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 87d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 70
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K012131.
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
K023048 · Beckman Coulter, Inc. · Nov 2002
BENZODIAZEPINES
K013143 · Abbott Laboratories · Mar 2002
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · ACON Laboratories, Inc. · Sep 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
K003879 · Alfa Scientific Designs, Inc. · May 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
K003881 · Alfa Scientific Designs, Inc. · May 2001
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458 · Dade Behring, Inc. · Apr 2000