Cleared Traditional

K983702 - MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES

K983702 is an FDA 510(k) clearance for MODIFICATION TO ABUSCREEN ONLINE FOR BE..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K983702

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.

JXM Device Classification - Class 2, Special Controls

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 82
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
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
K982831 · OraSure Technologies, Inc. · Nov 1998
QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
K981687 · Phamatech · Jun 1998