Cleared Traditional

EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY (K811034) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K811034 · Syva Co. · Toxicology device
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May 1981
Decision
15d
Days
Class 2
Risk

K811034 is an FDA 510(k) clearance for the EMIT-CAD N-ACETYLPROCAINAMIDE 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 May 1, 1981 after a review of 15 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 K811034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1981
Decision Date May 01, 1981
Days to Decision 15 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
72d faster than avg
Panel avg: 87d · This submission: 15d
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 24
Devices cleared under the same product code (LAR) and FDA review panel - the closest regulatory comparables to K811034.
ONLINE TDM PROCAINAMIDE
K060773 · Roche Diagnostics Corp. · Aug 2006
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
K032573 · Dade Behring, Inc. · Oct 2003
CEDIA N-ACETYLPROCAINAMIDE ASSAY
K963306 · Boehringer Mannheim Corp. · Oct 1996
CEDIA PROCAINAMIDE ASSAY
K962099 · Boehringer Mannheim Corp. · Aug 1996
ABBOTT AXSM PROCAINAMIDE ASSAY
K955444 · Abbott Laboratories · Apr 1996
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
K942847 · Roche Diagnostic Systems, Inc. · Dec 1994