Cleared Traditional

K810463 - EMIT-ST SERUM BENZODIAZEPINE ASSAY

K810463 is the FDA 510(k) clearance for EMIT-ST SERUM BENZODIAZEPINE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K810463 · Syva Co. · Toxicology device
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Mar 1981
Decision
11d
Days
Class 2
Risk

K810463 is an FDA 510(k) clearance for the EMIT-ST SERUM BENZODIAZEPINE ASSAY. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on March 6, 1981 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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 K810463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1981
Decision Date March 06, 1981
Days to Decision 11 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
76d faster than avg
Panel avg: 87d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 69
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K810463.
ACA BENZODIAZEPINES SCREEN TEST PK
K842387 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984
EMIT ST SERUM BENZODIAZEPINE ASSAY
K840236 · Syva Co. · Mar 1984
MODIF. OF EMIT URINE BENZODIAZEPINE
K833578 · Syva Co. · Jan 1984
EMIT-STM BENZODIAZEPINE ASSAY
K802616 · Syva Co. · Oct 1980
EMIT-TOX SERUM BENZODIAZEPINE ASSAY
K790736 · Syva Co. · Apr 1979