Cleared Special

K024098 - COBAS INTEGRA CREATININE PLUS VER.2 ASSAY

K024098 is an FDA 510(k) clearance for COBAS INTEGRA CREATININE PLUS VER.2 ASSAY, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code JFY cleared through the Special 510(k) pathway after a 7-day FDA review.

K024098 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
7d
Days
Class 2
Risk

K024098 is an FDA 510(k) clearance for the COBAS INTEGRA CREATININE PLUS VER.2 ASSAY. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 19, 2002 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K024098

510(k) Number K024098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2002
Decision Date December 19, 2002
Days to Decision 7 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 88d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

JFY Device Classification - Class 2, Special Controls

Product Code JFY Enzymatic Method, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 Chemistry devices follow this clearance model.

Regulatory Peers - JFY Enzymatic Method, Creatinine

All 48
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K024098.
POLY-CHEM CREATININE
K061944 · Polymedco, Inc. · Nov 2006
CREATININE LIQUICOLOR
K050283 · Stanbio Laboratory · Jun 2005
IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
K030035 · Diametrics Medical, Inc. · Jun 2003
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · Bayer Corp. · Jul 2002
WIENER LAB. CREATININA CINETICA AA
K012065 · Wiener Laboratories Saic · Oct 2001
BIOSCANNER CREATININE TEST STRIPS
K010456 · Polymer Technology Systems, Inc. · Jun 2001
K024098 · COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
Download PDF FDA Summary Roche Diagnostics Cor…