Cleared Special

K023048 - MODIFICATION TO SYNCHRON SYSTEMS BENZOD...

K023048 is the FDA 510(k) clearance for MODIFICATION TO SYNCHRON SYSTEMS BENZOD... by Beckman Coulter, Inc.. It is a Class 2 Toxicology device (product code JXM) cleared through the Special 510(k) pathway after a 55-day FDA review.

K023048 · Beckman Coulter, Inc. · Toxicology device
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Nov 2002
Decision
55d
Days
Class 2
Risk

K023048 is an FDA 510(k) clearance for the MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 7, 2002 after a review of 55 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K023048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2002
Decision Date November 07, 2002
Days to Decision 55 days
Submission Type Special
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
32d faster than avg
Panel avg: 87d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

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 K023048.
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
K043556 · Beckman Coulter, Inc. · Mar 2005
ONLINE DAT BENZODIAZEPINES PLUS
K043327 · Roche Diagnostics Corp. · Feb 2005
BENZODIAZEPINE ENZYME IMMUNOASSAY
K032365 · Lin-Zhi International, Inc. · Sep 2003
BENZODIAZEPINES
K013143 · Abbott Laboratories · Mar 2002
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · ACON Laboratories, Inc. · Sep 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
K003879 · Alfa Scientific Designs, Inc. · May 2001