Cleared Traditional

K851060 - EMIT QST N-ACETYLPROCAINAMIDE ASSAY

K851060 is the FDA 510(k) clearance for EMIT QST 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 21-day FDA review.

K851060 · Syva Co. · Toxicology device
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Apr 1985
Decision
21d
Days
Class 2
Risk

K851060 is an FDA 510(k) clearance for the EMIT QST N-ACETYLPROCAINAMIDE ASSAY. Classified as Enzyme Immunoassay, N-acetylprocainamide (product code LAN), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on April 5, 1985 after a review of 21 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 K851060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1985
Decision Date April 05, 1985
Days to Decision 21 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
66d faster than avg
Panel avg: 87d · This submission: 21d
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.

Regulatory Peers - LAN Enzyme Immunoassay, N-acetylprocainamide

All 17
Devices cleared under the same product code (LAN) and FDA review panel - the closest regulatory comparables to K851060.
STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
K860140 · American Dade · Feb 1986
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I
K853547 · American Dade · Sep 1985
COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS
K852319 · Roche Diagnostic Systems, Inc. · Jun 1985
N-ACETYLPROCAINAMIDE ACA-ANALYTICAL
K833378 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
N-ACETYLPROCAINAMIDE ASSAY FOR COBAS
K832098 · Syva Co. · Aug 1983
AMES TDA N-ACETYL-PROCAINAMIDE TEST
K831399 · Miles Laboratories, Inc. · Jun 1983