Cleared Traditional

K991598 - COBAS INTEGRA ACETAMINOPHEN

K991598 is the FDA 510(k) clearance for COBAS INTEGRA ACETAMINOPHEN by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code LDP) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K991598 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
73d
Days
Class 2
Risk

K991598 is an FDA 510(k) clearance for the COBAS INTEGRA ACETAMINOPHEN. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 22, 1999 after a review of 73 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K991598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1999
Decision Date July 22, 1999
Days to Decision 73 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 87d · This submission: 73d
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 22
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K991598.
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
K011465 · Beckman Coulter, Inc. · Jun 2001
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · Dade Behring, Inc. · Oct 2000
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
K000494 · Beckman Coulter, Inc. · Apr 2000
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