Cleared Traditional

K863079 - CREATINKINETIC

K863079 is the FDA 510(k) clearance for CREATINKINETIC by J. D. Assoc.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K863079 · J. D. Assoc. · Chemistry device
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Dec 1986
Decision
122d
Days
Class 2
Risk

K863079 is an FDA 510(k) clearance for the CREATINKINETIC. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on December 12, 1986 after a review of 122 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 J. D. Assoc. devices

Submission Details

510(k) Number K863079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date December 12, 1986
Days to Decision 122 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
34d slower than avg
Panel avg: 88d · This submission: 122d
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 K863079.
ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT
K873310 · Abbott Laboratories · Sep 1987
CURAD MEDICATED PLASTIC STRIPS
K872310 · The Kendal Co. · Aug 1987
CREATININE REAGENT - PICRIC ACID METHOD
K870366 · Trace Scientific , Ltd. · Aug 1987
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95
K863738 · Em Diagnostic Systems, Inc. · Nov 1986
CREATININE PROCEDURE
K863261 · Data Medical Associates, Inc. · Oct 1986
CREATININE PROCEDURE
K861655 · Data Medical Associates, Inc. · Jul 1986