Cleared Traditional

K832045 - ACETAMINOPHER ASSAY KIT

K832045 is an FDA 510(k) clearance for ACETAMINOPHER ASSAY KIT, manufactured by Quantimetrix Corp.. The device is a Class 2 Toxicology device with product code LDP cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K832045 · Quantimetrix Corp. · Toxicology device
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Oct 1983
Decision
102d
Days
Class 2
Risk

K832045 is an FDA 510(k) clearance for the ACETAMINOPHER ASSAY KIT. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Quantimetrix Corp. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quantimetrix Corp. devices

FDA 510(k) Submission Details - K832045

510(k) Number K832045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1983
Decision Date October 04, 1983
Days to Decision 102 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
15d slower than avg
Panel avg: 87d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDP Device Classification - Class 2, Special Controls

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 K832045.
EMIT QST ACETAMINOPHEN ASSAY
K844962 · Syva Co. · Jan 1985
ACA ACETAMINOPHEN ANALYTICAL TEST PACK
K842548 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984
TDX ACETAMINOPHEN
K840941 · Abbott Laboratories · May 1984
ACETAMINOPHEN(PARACETAMOL
K832567 · Bio-Analytics Laboratories, Inc. · Sep 1983
PROCEDURE #430 & REAGENTS FOR ACETAMIN
K822313 · Sigma Chemical Co. · Aug 1982
EMIT-TOX ACETAMINOPHEN ASSAY
K821379 · Syva Co. · May 1982