Cleared Traditional

K823128 - ADVANCE EMIT CAD PROCAINAMIDE ASSAY

K823128 is the FDA 510(k) clearance for ADVANCE EMIT CAD PROCAINAMIDE ASSAY by Syva Co.. It is a Class 2 Chemistry device (product code LAR) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K823128 · Syva Co. · Chemistry device
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Nov 1982
Decision
35d
Days
Class 2
Risk

K823128 is an FDA 510(k) clearance for the ADVANCE EMIT CAD PROCAINAMIDE ASSAY. Classified as Enzyme Immunoassay, Procainamide (product code LAR), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1982 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - the FDA in vitro diagnostics and chemistry 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 K823128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1982
Decision Date November 29, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAR Enzyme Immunoassay, Procainamide
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 Chemistry devices follow this clearance model.

Regulatory Peers - LAR Enzyme Immunoassay, Procainamide

All 22
Devices cleared under the same product code (LAR) and FDA review panel - the closest regulatory comparables to K823128.
PROCAINAMIDE ANALYTICAL TEST PACK
K833384 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
EMIT CAD PROCAINAMIDE ASSAY
K832718 · Syva Co. · Sep 1983
AMES TDA PROCAINAMIDE TEST
K831400 · Miles Laboratories, Inc. · Jun 1983
EMIT-CAD PROCAINAMIDE ASSAY
K811770 · Syva Co. · Jul 1981
EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY
K811034 · Syva Co. · May 1981
EMIT QUINIDINE ASSAY
K790403 · Syva Co. · Mar 1979