Cleared Traditional

K821969 - ACETAMINOPHEN STAT-PAK REAGENT SET

K821969 is the FDA 510(k) clearance for ACETAMINOPHEN STAT-PAK REAGENT SET by Clin Tech Diagnostics Corp.. It is a Class 2 Toxicology device (product code LDP) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K821969 · Clin Tech Diagnostics Corp. · Toxicology device
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Jul 1982
Decision
15d
Days
Class 2
Risk

K821969 is an FDA 510(k) clearance for the ACETAMINOPHEN STAT-PAK REAGENT SET. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Clin Tech Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1982 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3030 - 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 Clin Tech Diagnostics Corp. devices

Submission Details

510(k) Number K821969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1982
Decision Date July 16, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
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 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 Toxicology devices follow this clearance model.

Regulatory Peers - LDP Colorimetry, Acetaminophen

All 31
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K821969.
TDX ACETAMINOPHEN
K840941 · Abbott Laboratories · May 1984
ACETAMINOPHER ASSAY KIT
K832045 · Quantimetrix Corp. · Oct 1983
PROCEDURE #430 & REAGENTS FOR ACETAMIN
K822313 · Sigma Chemical Co. · Aug 1982
EMIT-TOX ACETAMINOPHEN ASSAY
K821379 · Syva Co. · May 1982
STANBIO ACETAMINOPHEN TEST SET #0850
K801014 · Stanbio Laboratory · Jun 1980