Cleared Traditional

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT) (K881639) - FDA 510(k) Clearance

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

K881639 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1988
Decision
85d
Days
Class 2
Risk

K881639 is an FDA 510(k) clearance for the KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT). Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - 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 K881639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1988
Decision Date July 08, 1988
Days to Decision 85 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
3d faster than avg
Panel avg: 88d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEK Biuret (colorimetric), Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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 - CEK Biuret (colorimetric), Total Protein

All 22
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K881639.
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
K893915 · Em Diagnostic Systems, Inc. · Aug 1989
TOTAL PROTEIN REAGENT
K890278 · Sigma Chemical Co. · Mar 1989
TOTAL PROTEIN TEST (TP) ITEM #65670
K884703 · Em Diagnostic Systems, Inc. · Jan 1989
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476 · Em Diagnostic Systems, Inc. · Nov 1987
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
K863005 · Em Diagnostic Systems, Inc. · Aug 1986
VISION TOTAL PROTEIN
K861798 · Abbott Laboratories · Jun 1986