Cleared Traditional

K030035 - IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE

K030035 is the FDA 510(k) clearance for IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE by Diametrics Medical, Inc.. It is a Class 2 Chemistry device (product code JFY) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K030035 · Diametrics Medical, Inc. · Chemistry device
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Jun 2003
Decision
173d
Days
Class 2
Risk

K030035 is an FDA 510(k) clearance for the IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Diametrics Medical, Inc. (Roseville, US). The FDA issued a Cleared decision on June 25, 2003 after a review of 173 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diametrics Medical, Inc. devices

Submission Details

510(k) Number K030035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2003
Decision Date June 25, 2003
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 88d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K030035.
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775 · Wako Chemicals USA, Inc. · Feb 2007
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K063591 · Ortho-Clinical Diagnostics, Inc. · Dec 2006
CREATININE LIQUICOLOR
K050283 · Stanbio Laboratory · Jun 2005
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · Roche Diagnostics Corp. · Dec 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · Bayer Corp. · Jul 2002
CREATININE PLUS
K003261 · Roche Diagnostics Corp. · Nov 2000