Cleared Traditional

EMIT ST SERUM ETHYL ALCOHOL ASSAY (K840400) - FDA 510(k) Clearance

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

K840400 · Syva Co. · Toxicology device
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Mar 1984
Decision
53d
Days
Class 2
Risk

K840400 is an FDA 510(k) clearance for the EMIT ST SERUM ETHYL ALCOHOL ASSAY. Classified as Nad-nadh, Specific Reagent For Alcohol Enzyme Method (product code DML), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3040 - 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 K840400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1984
Decision Date March 23, 1984
Days to Decision 53 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
34d faster than avg
Panel avg: 87d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DML Nad-nadh, Specific Reagent For Alcohol Enzyme Method
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3040
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 - DML Nad-nadh, Specific Reagent For Alcohol Enzyme Method

All 12
Devices cleared under the same product code (DML) and FDA review panel - the closest regulatory comparables to K840400.
ETHANOL
K013538 · Abbott Laboratories · Dec 2001
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
K993980 · Syva Co. · Feb 2000
AXSYM REA ETHANOL
K953765 · Abbott Laboratories · Sep 1995
BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY
K952839 · Boehringer Mannheim Corp. · Aug 1995
EMDS(TM) ALCOHOL TESTPACKS, #67691/95
K863419 · Em Diagnostic Systems, Inc. · Sep 1986
EMIT ST URINE ETHYL ALCOHOL ASSAY
K840171 · Syva Co. · Mar 1984