Cleared Traditional

K921013 - SYVA EMIT II METHAQUALONE ASSAY

K921013 is the FDA 510(k) clearance for SYVA EMIT II METHAQUALONE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code KXS) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K921013 · Syva Co. · Toxicology device
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Optimized for regulatory review, auditing and printing
May 1992
Decision
71d
Days
Class 2
Risk

K921013 is an FDA 510(k) clearance for the SYVA EMIT II METHAQUALONE ASSAY. Classified as Radioimmunoassay, Methaqualone (product code KXS), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on May 13, 1992 after a review of 71 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 Syva Co. devices

Submission Details

510(k) Number K921013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1992
Decision Date May 13, 1992
Days to Decision 71 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
16d faster than avg
Panel avg: 87d · This submission: 71d
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 14
Devices cleared under the same product code (KXS) and FDA review panel - the closest regulatory comparables to K921013.
SYNCHRON SYSTEMS METHAQUALONE REAGENT
K955676 · Beckman Instruments, Inc. · Mar 1996
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE
K945187 · Roche Diagnostic Systems, Inc. · Apr 1995
METHAQUALONE ENZYME IMMUNOASSAY
K940123 · Diagnostic Reagents, Inc. · May 1994
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