Cleared Traditional

K860418 - CREATININE REAGENT SET

K860418 is the FDA 510(k) clearance for CREATININE REAGENT SET by Sterling Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K860418 · Sterling Diagnostics, Inc. · Chemistry device
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Feb 1986
Decision
7d
Days
Class 2
Risk

K860418 is an FDA 510(k) clearance for the CREATININE REAGENT SET. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on February 11, 1986 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. 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 Sterling Diagnostics, Inc. devices

Submission Details

510(k) Number K860418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1986
Decision Date February 11, 1986
Days to Decision 7 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
81d faster than avg
Panel avg: 88d · This submission: 7d
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 111
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K860418.
CREATININE PROCEDURE
K863261 · Data Medical Associates, Inc. · Oct 1986
CREATININE PROCEDURE
K861655 · Data Medical Associates, Inc. · Jul 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA)
K861819 · Eastman Kodak Company · Jun 1986
VISION CREATININE
K854846 · Abbott Laboratories · Jan 1986
IN-VITRO TEST FOR THE DETERMINATION OF CREATININE
K854178 · Clinical Data, Inc. · Nov 1985
AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &
K853888 · American Research Products Co. · Oct 1985