Cleared Traditional

K043327 - ONLINE DAT BENZODIAZEPINES PLUS

K043327 is the FDA 510(k) clearance for ONLINE DAT BENZODIAZEPINES PLUS by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K043327 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
67d
Days
Class 2
Risk

K043327 is an FDA 510(k) clearance for the ONLINE DAT BENZODIAZEPINES PLUS. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 7, 2005 after a review of 67 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K043327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2004
Decision Date February 07, 2005
Days to Decision 67 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
20d faster than avg
Panel avg: 87d · This submission: 67d
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 63
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K043327.
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
K051307 · Beckman Coulter, Inc. · Jun 2005
RANDOX BENZODIAZEPINE CLASS ASSAY
K050179 · Randox Laboratories, Ltd. · May 2005
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
K043556 · Beckman Coulter, Inc. · Mar 2005
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
K023048 · Beckman Coulter, Inc. · Nov 2002
BENZODIAZEPINES
K013143 · Abbott Laboratories · Mar 2002
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · ACON Laboratories, Inc. · Sep 2001