Cleared Traditional

K983702 - MODIFICATION TO ABUSCREEN ONLINE FOR BE...

K983702 is the FDA 510(k) clearance for MODIFICATION TO ABUSCREEN ONLINE FOR BE... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K983702 · Roche Diagnostic Systems, Inc. · Toxicology device
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Feb 1999
Decision
113d
Days
Class 2
Risk

K983702 is an FDA 510(k) clearance for the MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on February 11, 1999 after a review of 113 days - within the typical 510(k) review window.

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: 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K983702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1998
Decision Date February 11, 1999
Days to Decision 113 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
26d slower than avg
Panel avg: 87d · This submission: 113d
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 67
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K983702.
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
K993985 · Syva Co. · Jan 2000
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
K991443 · Roche Diagnostics Corp. · Jun 1999
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
K991079 · Princeton BioMeditech Corp. · Apr 1999
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
K983174 · Roche Diagnostic Systems, Inc. · Nov 1998
QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
K981687 · Phamatech · Jun 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