Cleared Traditional

K902172 - COULTER CREATININE REAGENT

K902172 is the FDA 510(k) clearance for COULTER CREATININE REAGENT by Coulter Corp.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K902172 · Coulter Corp. · Chemistry device
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Jun 1990
Decision
45d
Days
Class 2
Risk

K902172 is an FDA 510(k) clearance for the COULTER CREATININE REAGENT. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Coulter Corp. (Hialeah, US). The FDA issued a Cleared decision on June 28, 1990 after a review of 45 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 Coulter Corp. devices

Submission Details

510(k) Number K902172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1990
Decision Date June 28, 1990
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
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 110
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K902172.
CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED
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K901229 · Technicon Instruments Corp. · May 1990
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K901298 · Olympus Corp. · Apr 1990
AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791
K900666 · American Research Products Co. · Apr 1990