Cleared Traditional

K843605 - EMIT 700 METHAQUALONE ASSAY

K843605 is the FDA 510(k) clearance for EMIT 700 METHAQUALONE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code KXS) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K843605 · Syva Co. · Toxicology device
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Oct 1984
Decision
22d
Days
Class 2
Risk

K843605 is an FDA 510(k) clearance for the EMIT 700 METHAQUALONE ASSAY. Classified as Radioimmunoassay, Methaqualone (product code KXS), Class II - Special Controls.

Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 22 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 K843605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1984
Decision Date October 05, 1984
Days to Decision 22 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 87d · This submission: 22d
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 K843605.
REVISED LABELING FOR SYVA METHAQUALONE ASSAYS
K874199 · Syva Co. · Oct 1987
LABELING CHANGE COAT-A-COUNT METHAQUALONE
K873759 · Diagnostic Products Corp. · Oct 1987
COAT-A-COUNT METHAQUALONE TKMQ1
K870935 · Diagnostic Products Corp. · Mar 1987
EMIT ST URINE METHAQUALONE ASSAY
K840164 · Syva Co. · Mar 1984
ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
K830461 · Hoffmann-La Roche, Inc. · Mar 1983
EMIT D.A.V. METHAQUALONE ASSAY
K822051 · Syva Co. · Jul 1982