Cleared Traditional

K012133 - LIVESURE BARBITURATES SCREEN TEST

K012133 is an FDA 510(k) clearance for LIVESURE BARBITURATES SCREEN TEST, manufactured by Pan Probe Biotech, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K012133 · Pan Probe Biotech, Inc. · Toxicology device
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Jul 2001
Decision
11d
Days
Class 2
Risk

K012133 is an FDA 510(k) clearance for the LIVESURE BARBITURATES SCREEN TEST. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), 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 862.3150 - 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

FDA 510(k) Submission Details - K012133

510(k) Number K012133 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.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 92
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K012133.
BARBITURATES
K012996 · Abbott Laboratories · Mar 2002
VISUALINE BARBITURATES DIPSTRIP TEST
K020136 · Sun Biomedical Laboratories, Inc. · Mar 2002
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
K012824 · ACON Laboratories, Inc. · Nov 2001
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
K003647 · Alfa Scientific Designs, Inc. · May 2001
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
K010125 · Alfa Scientific Designs, Inc. · May 2001
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
K010934 · Syva Co., Dade Behring, Inc. · Apr 2001