Cleared Traditional

K781378 - EMIT N-ACETYLPROCAINAMIDE ASSAY

K781378 is the FDA 510(k) clearance for EMIT N-ACETYLPROCAINAMIDE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code LAN) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K781378 · Syva Co. · Toxicology device
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Oct 1978
Decision
61d
Days
Class 2
Risk

K781378 is an FDA 510(k) clearance for the EMIT N-ACETYLPROCAINAMIDE ASSAY. Classified as Enzyme Immunoassay, N-acetylprocainamide (product code LAN), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1978 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - 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 K781378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1978
Decision Date October 10, 1978
Days to Decision 61 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
26d faster than avg
Panel avg: 87d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAN Enzyme Immunoassay, N-acetylprocainamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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.