Cleared Traditional

K840171 - EMIT ST URINE ETHYL ALCOHOL ASSAY

K840171 is the FDA 510(k) clearance for EMIT ST URINE ETHYL ALCOHOL ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DML) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K840171 · Syva Co. · Toxicology device
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Mar 1984
Decision
62d
Days
Class 2
Risk

K840171 is an FDA 510(k) clearance for the EMIT ST URINE 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 19, 1984 after a review of 62 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 K840171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1984
Decision Date March 19, 1984
Days to Decision 62 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
25d faster than avg
Panel avg: 87d · This submission: 62d
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.