Cleared Traditional

K961373 - ACETAMINOPHEN SERUM TOX EIA ASSAY

K961373 is an FDA 510(k) clearance for ACETAMINOPHEN SERUM TOX EIA ASSAY, manufactured by Diagnostic Reagents, Inc.. The device is a Class 2 Toxicology device with product code LDP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K961373 · Diagnostic Reagents, Inc. · Toxicology device
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Jul 1996
Decision
90d
Days
Class 2
Risk

K961373 is an FDA 510(k) clearance for the ACETAMINOPHEN SERUM TOX EIA ASSAY. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 8, 1996 after a review of 90 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 Diagnostic Reagents, Inc. devices

FDA 510(k) Submission Details - K961373

510(k) Number K961373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1996
Decision Date July 08, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 87d · This submission: 90d
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 K961373.
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
K981059 · Diagnostic Chemicals , Ltd. · May 1998
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
K980031 · Diagnostic Chemicals , Ltd. · Mar 1998
ACETAMINOPHEN FLEX REAGENT CARTRIDGE
K963244 · Dade Intl., Inc. · Sep 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
K954933 · Johnson & Johnson Clinical Diagnostics, Inc. · Dec 1995
ACETAMINOPHEN ASSAY
K952949 · Diagnostic Chemicals , Ltd. · Sep 1995
AXSYM ACETAMINOPHEN
K953094 · Abbott Laboratories · Aug 1995