Cleared Traditional

K914167 - CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE

K914167 is an FDA 510(k) clearance for CLINICAL CHEM.ANAL.ACID, manufactured by Eastman Kodak Company. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K914167

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.

CKE Device Classification - Class 2, Special Controls

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

All 7
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
ACID PHOSPHATASE REAGENT SET
K821526 · Anco Medical Reagents & Assoc. · Jun 1982
STANBIO PROSTATIC ACID PHOSPHATASE TEST
K800693 · Stanbio Laboratory · Apr 1980