Cleared Traditional

K982152 - QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152

K982152 is an FDA 510(k) clearance for QUICK SCREEN BARBITURATE SCREENING TEST..., manufactured by Phamatech. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K982152 · Phamatech · Toxicology device
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Optimized for regulatory review, auditing and printing
Sep 1998
Decision
95d
Days
Class 2
Risk

K982152 is an FDA 510(k) clearance for the QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PR.... Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on September 21, 1998 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Phamatech devices

FDA 510(k) Submission Details - K982152

510(k) Number K982152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1998
Decision Date September 21, 1998
Days to Decision 95 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
8d slower than avg
Panel avg: 87d · This submission: 95d
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 91
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K982152.
ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO
K991082 · Princeton BioMeditech Corp. · Apr 1999
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
K991084 · Princeton BioMeditech Corp. · Apr 1999
AUTO-LYTE BARBITURATES EIA
K982745 · OraSure Technologies, Inc. · Nov 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
QUIKSTRIP ONE STEP BARBITURATE TEST
K974712 · Syntron Bioresearch, Inc. · Feb 1998