Cleared Traditional

K850953 - EMIT 700 METHADONE ASSAY

K850953 is the FDA 510(k) clearance for EMIT 700 METHADONE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K850953 · Syva Co. · Toxicology device
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Apr 1985
Decision
25d
Days
Class 2
Risk

K850953 is an FDA 510(k) clearance for the EMIT 700 METHADONE ASSAY. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on April 1, 1985 after a review of 25 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 Syva Co. devices

Submission Details

510(k) Number K850953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date April 01, 1985
Days to Decision 25 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 87d · This submission: 25d
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 47
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K850953.
REVISED LABELING FOR SYVA METHADONE ASSAYS
K873899 · Syva Co. · Oct 1987
LABELING CHANGES COAT-A-COUNT METHADONE IN URINE
K873750 · Diagnostic Products Corp. · Oct 1987
COAT-A-COUNT METHADONE TKMD1
K870937 · Diagnostic Products Corp. · Mar 1987
EMIT D.A.U. METHADONE ASSAY
K842676 · Syva Co. · Sep 1984
EMIT ST URINE METHADONE ASSAY
K840060 · Syva Co. · Mar 1984