Cleared Traditional

K910147 - CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED

K910147 is an FDA 510(k) clearance for CREATININE REAGENT(CREAT), manufactured by Olympus Corp.. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K910147 · Olympus Corp. · Chemistry device
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Mar 1991
Decision
56d
Days
Class 2
Risk

K910147 is an FDA 510(k) clearance for the CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on March 11, 1991 after a review of 56 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. 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 Olympus Corp. devices

FDA 510(k) Submission Details - K910147

510(k) Number K910147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1991
Decision Date March 11, 1991
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGX Device Classification - Class 2, Special Controls

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 143
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K910147.
SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,
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K902561 · Roche Diagnostic Systems, Inc. · Sep 1990
SYNERMED CREATININE REAGENT KIT
K903296 · Synermed, Inc. · Aug 1990