Cleared Traditional

K961373 - ACETAMINOPHEN SERUM TOX EIA ASSAY

K961373 is the FDA 510(k) clearance for ACETAMINOPHEN SERUM TOX EIA ASSAY by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (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

Submission Details

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.

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 27
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K961373.
COBAS INTEGRA ACETAMINOPHEN
K991598 · Roche Diagnostics Corp. · Jul 1999
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 ASSAY
K952949 · Diagnostic Chemicals , Ltd. · Sep 1995
AXSYM ACETAMINOPHEN
K953094 · Abbott Laboratories · Aug 1995
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
K885097 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1989