Cleared Traditional

K963244 - ACETAMINOPHEN FLEX REAGENT CARTRIDGE

K963244 is the FDA 510(k) clearance for ACETAMINOPHEN FLEX REAGENT CARTRIDGE by Dade Intl., Inc.. It is a Class 2 Toxicology device (product code LDP) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K963244 · Dade Intl., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
35d
Days
Class 2
Risk

K963244 is an FDA 510(k) clearance for the ACETAMINOPHEN FLEX REAGENT CARTRIDGE. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Newark, US). The FDA issued a Cleared decision on September 23, 1996 after a review of 35 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 Dade Intl., Inc. devices

Submission Details

510(k) Number K963244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1996
Decision Date September 23, 1996
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 87d · This submission: 35d
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 28
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K963244.
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 SERUM TOX EIA ASSAY
K961373 · Diagnostic Reagents, Inc. · Jul 1996
ACETAMINOPHEN ASSAY
K952949 · Diagnostic Chemicals , Ltd. · Sep 1995
AXSYM ACETAMINOPHEN
K953094 · Abbott Laboratories · Aug 1995