Cleared Traditional

K981687 - QUICKSCREEN BENZODIAZEPINES SCREENING T...

K981687 is the FDA 510(k) clearance for QUICKSCREEN BENZODIAZEPINES SCREENING T... by Phamatech. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K981687 · Phamatech · Toxicology device
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Optimized for regulatory review, auditing and printing
Jun 1998
Decision
21d
Days
Class 2
Risk

K981687 is an FDA 510(k) clearance for the QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKS.... Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on June 3, 1998 after a review of 21 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 Phamatech devices

Submission Details

510(k) Number K981687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1998
Decision Date June 03, 1998
Days to Decision 21 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
66d faster than avg
Panel avg: 87d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 69
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K981687.
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
K991079 · Princeton BioMeditech Corp. · Apr 1999
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
K983702 · Roche Diagnostic Systems, Inc. · Feb 1999
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
K983174 · Roche Diagnostic Systems, Inc. · Nov 1998
ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B
K974181 · Princeton BioMeditech Corp. · Dec 1997
CEDIA DAU BENZODIAZEPINE ASSAY
K962734 · Boehringer Mannheim Corp. · Dec 1996
ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
K962672 · Princeton BioMeditech Corp. · Aug 1996