Cleared Traditional

K811770 - EMIT-CAD PROCAINAMIDE ASSAY

K811770 is the FDA 510(k) clearance for EMIT-CAD PROCAINAMIDE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code LAR) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K811770 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1981
Decision
18d
Days
Class 2
Risk

K811770 is an FDA 510(k) clearance for the 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 July 10, 1981 after a review of 18 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 K811770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1981
Decision Date July 10, 1981
Days to Decision 18 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
69d faster than avg
Panel avg: 87d · This submission: 18d
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 Toxicology devices follow this clearance model.

Regulatory Peers - LAR Enzyme Immunoassay, Procainamide

All 23
Devices cleared under the same product code (LAR) and FDA review panel - the closest regulatory comparables to K811770.
EMIT CAD PROCAINAMIDE ASSAY
K832718 · Syva Co. · Sep 1983
AMES TDA PROCAINAMIDE TEST
K831400 · Miles Laboratories, Inc. · Jun 1983
ADVANCE EMIT CAD PROCAINAMIDE ASSAY
K823128 · Syva Co. · Nov 1982
EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY
K811034 · Syva Co. · May 1981
EMIT QUINIDINE ASSAY
K790403 · Syva Co. · Mar 1979
EMIT PROCAINAMIDE ASSAY
K781382 · Syva Co. · Oct 1978