Cleared Traditional

SYVA EMIT II METHAQUALONE ASSAY (K921013) - FDA 510(k) Clearance

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

K921013 · Syva Co. · Toxicology device
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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 15
Devices cleared under the same product code (KXS) and FDA review panel - the closest regulatory comparables to K921013.
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
K993986 · Syva Co. · Jan 2000
REVISED LABELING FOR SYVA METHAQUALONE ASSAYS
K874199 · Syva Co. · Oct 1987
EMIT 700 METHAQUALONE ASSAY
K843605 · Syva Co. · Oct 1984
EMIT ST URINE METHAQUALONE ASSAY
K840164 · Syva Co. · Mar 1984
EMIT D.A.V. METHAQUALONE ASSAY
K822051 · Syva Co. · Jul 1982
EMIT ST URINE METHAGUALONE ASSAY
K821768 · Syva Co. · Jun 1982