Cleared Traditional

K941837 - ROCHE REAGENT FOR CREATININE

K941837 is the FDA 510(k) clearance for ROCHE REAGENT FOR CREATININE by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K941837 · Roche Diagnostic Systems, Inc. · Chemistry device
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Aug 1994
Decision
135d
Days
Class 2
Risk

K941837 is an FDA 510(k) clearance for the ROCHE REAGENT FOR CREATININE. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 26, 1994 after a review of 135 days - within the typical 510(k) review window.

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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K941837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1994
Decision Date August 26, 1994
Days to Decision 135 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
47d slower than avg
Panel avg: 88d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, 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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 100
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K941837.
SIGMA DIAGNOSTICS CREATININE REAGENT KIT
K963534 · Sigma Diagnostics, Inc. · Sep 1996
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
K951595 · Roche Diagnostic Systems, Inc. · Sep 1995
CREATININE-PO REAGENT KIT
K943924 · Synermed, Inc. · Sep 1994
KODAK EKTACHEM DT SLIDES (URCR)
K934071 · Eastman Kodak Company · Mar 1994
CREATININE-S ASSAY
K934587 · Diagnostic Chemicals , Ltd. · Mar 1994
OLYMPUS CREATININE REAGENT
K934361 · Olympus Corp. · Nov 1993