Cleared Traditional

K914167 - CLINICAL CHEM.ANAL.ACID

K914167 is the FDA 510(k) clearance for CLINICAL CHEM.ANAL.ACID by Eastman Kodak Company. It is a Class 2 Chemistry device (product code CKE) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K914167 · Eastman Kodak Company · Chemistry device
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Mar 1992
Decision
182d
Days
Class 2
Risk

K914167 is an FDA 510(k) clearance for the CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE. Classified as Acid Phosphatase, Thymolphthale Inmonophosphate (product code CKE), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 17, 1992 after a review of 182 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1020 - 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 Eastman Kodak Company devices

Submission Details

510(k) Number K914167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1991
Decision Date March 17, 1992
Days to Decision 182 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 88d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CKE Acid Phosphatase, Thymolphthale Inmonophosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1020
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 - CKE Acid Phosphatase, Thymolphthale Inmonophosphate

Devices cleared under the same product code (CKE) and FDA review panel - the closest regulatory comparables to K914167.
ACID PHOSPHATASE TEST
K873726 · King Diagnostics, Inc. · Jan 1988
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K864230 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1986
ACID PHOSPHATASE REAGENT SET
K860476 · Sterling Diagnostics, Inc. · Mar 1986
ACID PHOSPHATASE ASSAY KIT
K843380 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984
STANBIO PROSTATIC ACID PHOSPHATASE TEST
K800693 · Stanbio Laboratory · Apr 1980
DATA-ZYME ACIA PHOSPHATASE PROCEDURE
K790524 · Data Medical Associates, Inc. · May 1979