Cleared Traditional

SYNCHRON SYSTEMS METHAQUALONE REAGENT (K955676) - FDA 510(k) Clearance

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

K955676 · Beckman Instruments, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
80d
Days
Class 2
Risk

K955676 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS METHAQUALONE REAGENT. Classified as Radioimmunoassay, Methaqualone (product code KXS), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 4, 1996 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3630 - 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 K955676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1995
Decision Date March 04, 1996
Days to Decision 80 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
7d faster than avg
Panel avg: 87d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXS Radioimmunoassay, Methaqualone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3630
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 - KXS Radioimmunoassay, Methaqualone

All 11
Devices cleared under the same product code (KXS) and FDA review panel - the closest regulatory comparables to K955676.
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
K993986 · Syva Co. · Jan 2000
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE
K945187 · Roche Diagnostic Systems, Inc. · Apr 1995
SYVA EMIT II METHAQUALONE ASSAY
K921013 · Syva Co. · May 1992
REVISED LABELING FOR METHAQUALONE TEST KIT
K874272 · Roche Diagnostic Systems, Inc. · Nov 1987
REVISED LABELING FOR SYVA METHAQUALONE ASSAYS
K874199 · Syva Co. · Oct 1987
LABELING CHANGE COAT-A-COUNT METHAQUALONE
K873759 · Diagnostic Products Corp. · Oct 1987