Cleared Traditional

K822313 - PROCEDURE #430 & REAGENTS FOR ACETAMIN

K822313 is the FDA 510(k) clearance for PROCEDURE #430 & REAGENTS FOR ACETAMIN by Sigma Chemical Co.. It is a Class 2 Chemistry device (product code LDP) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K822313 · Sigma Chemical Co. · Chemistry device
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Aug 1982
Decision
21d
Days
Class 2
Risk

K822313 is an FDA 510(k) clearance for the PROCEDURE #430 & REAGENTS FOR ACETAMIN. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1982 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3030 - 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K822313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1982
Decision Date August 24, 1982
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDP Colorimetry, Acetaminophen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3030
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 - LDP Colorimetry, Acetaminophen

All 27
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K822313.
ACA ACETAMINOPHEN ANALYTICAL TEST PACK
K842548 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984
TDX ACETAMINOPHEN
K840941 · Abbott Laboratories · May 1984
ACETAMINOPHER ASSAY KIT
K832045 · Quantimetrix Corp. · Oct 1983
EMIT-TOX ACETAMINOPHEN ASSAY
K821379 · Syva Co. · May 1982
STANBIO ACETAMINOPHEN TEST SET #0850
K801014 · Stanbio Laboratory · Jun 1980