Cleared Traditional

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA) (K861819) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K861819 · Eastman Kodak Company · Chemistry device
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Jun 1986
Decision
30d
Days
Class 2
Risk

K861819 is an FDA 510(k) clearance for the KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA). Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on June 11, 1986 after a review of 30 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 Eastman Kodak Company devices

Submission Details

510(k) Number K861819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1986
Decision Date June 11, 1986
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
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 38
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K861819.
EASY-TEST CREATININE (CREA) ITEM NO. 19009
K874088 · Em Diagnostic Systems, Inc. · Nov 1987
ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT
K873310 · Abbott Laboratories · Sep 1987
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95
K863738 · Em Diagnostic Systems, Inc. · Nov 1986
VISION CREATININE
K854846 · Abbott Laboratories · Jan 1986
TDX REA CREATININE
K843916 · Abbott Laboratories · Oct 1984
SYSTEMATE CREATININE 67223
K843105 · Em Diagnostic Systems, Inc. · Aug 1984