Cleared Traditional

K831399 - AMES TDA N-ACETYL-PROCAINAMIDE TEST

K831399 is the FDA 510(k) clearance for AMES TDA N-ACETYL-PROCAINAMIDE TEST by Miles Laboratories, Inc.. It is a Class 2 Immunology device (product code LAN) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K831399 · Miles Laboratories, Inc. · Immunology device
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Jun 1983
Decision
34d
Days
Class 2
Risk

K831399 is an FDA 510(k) clearance for the AMES TDA N-ACETYL-PROCAINAMIDE TEST. Classified as Enzyme Immunoassay, N-acetylprocainamide (product code LAN), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3320 - the FDA immunology 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K831399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1983
Decision Date June 02, 1983
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 104d · This submission: 34d
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 Immunology devices follow this clearance model.

Regulatory Peers - LAN Enzyme Immunoassay, N-acetylprocainamide

All 18
Devices cleared under the same product code (LAN) and FDA review panel - the closest regulatory comparables to K831399.
EMIT QST N-ACETYLPROCAINAMIDE ASSAY
K851060 · Syva Co. · Apr 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
TDX N-ACETYLPROCAINAMIDE
K830206 · Abbott Laboratories · Feb 1983
ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE
K823129 · Syva Co. · Nov 1982
EMIT N-ACETYLPROCAINAMIDE ASSAY
K781378 · Syva Co. · Oct 1978