Cleared Traditional

SYNCHRON SYSTEMS METHADONE REAGENT (K973069) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973069 · Beckman Instruments, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Sep 1997
Decision
35d
Days
Class 2
Risk

K973069 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS METHADONE REAGENT. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on September 22, 1997 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K973069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1997
Decision Date September 22, 1997
Days to Decision 35 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
52d faster than avg
Panel avg: 87d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 - DJR Enzyme Immunoassay, Methadone

All 25
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K973069.
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
K994005 · Syva Co. · Jan 2000
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
K983703 · Roche Diagnostic Systems, Inc. · Dec 1998
CEDIA DAU EDDP ASSAY
K980746 · Boehringer Mannheim Corp. · May 1998
AXSYM METHADONE
K953499 · Abbott Laboratories · Nov 1995
CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST
K944074 · Beckman Instruments, Inc. · Dec 1994
DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK
K934147 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993