Cleared Traditional

K850932 - CREATININE

K850932 is an FDA 510(k) clearance for CREATININE, manufactured by Dilab, Inc.. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K850932 · Dilab, Inc. · Chemistry device
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Jun 1985
Decision
110d
Days
Class 2
Risk

K850932 is an FDA 510(k) clearance for the CREATININE. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 110 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 Dilab, Inc. devices

FDA 510(k) Submission Details - K850932

510(k) Number K850932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date June 25, 1985
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
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 144
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K850932.
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
TECHNICON CHEMI
K852565 · Technicon Instruments Corp. · Jul 1985
CRE BUFFER CRE DYE
K851993 · Alpkem Corp. · May 1985
CREATINE LIQUID STABLE REAGENT SET
K851849 · Medical Analysis Systems, Inc. · May 1985
CREATININE REAGENT FOR DEMAND ANALYZER
K844332 · Advanced Biomedical Methods, Inc. · Jan 1985