Cleared Traditional

K974712 - QUIKSTRIP ONE STEP BARBITURATE TEST

K974712 is an FDA 510(k) clearance for QUIKSTRIP ONE STEP BARBITURATE TEST, manufactured by Syntron Bioresearch, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K974712 · Syntron Bioresearch, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
57d
Days
Class 2
Risk

K974712 is an FDA 510(k) clearance for the QUIKSTRIP ONE STEP BARBITURATE TEST. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Syntron Bioresearch, Inc. (Simi Valley, US). The FDA issued a Cleared decision on February 12, 1998 after a review of 57 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 Syntron Bioresearch, Inc. devices

FDA 510(k) Submission Details - K974712

510(k) Number K974712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1997
Decision Date February 12, 1998
Days to Decision 57 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
30d faster than avg
Panel avg: 87d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 89
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K974712.
QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152
K982152 · Phamatech · Sep 1998
ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN
K982551 · Roche Diagnostic Systems, Inc. · Aug 1998
QUICKPAC II ONE STEP BARBITURATE TEST
K980349 · Syntron Bioresearch, Inc. · Mar 1998
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST
K973047 · Drial Consultants, Inc. · Oct 1997
VERDICT BARBITURATES
K963529 · Editek, Inc. · Oct 1996
ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY
K962669 · Princeton BioMeditech Corp. · Aug 1996