Cleared Traditional

K873726 - ACID PHOSPHATASE TEST

K873726 is the FDA 510(k) clearance for ACID PHOSPHATASE TEST by King Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CKE) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K873726 · King Diagnostics, Inc. · Chemistry device
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Jan 1988
Decision
134d
Days
Class 2
Risk

K873726 is an FDA 510(k) clearance for the ACID PHOSPHATASE TEST. Classified as Acid Phosphatase, Thymolphthale Inmonophosphate (product code CKE), Class II - Special Controls.

Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 27, 1988 after a review of 134 days - within the typical 510(k) review window.

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 King Diagnostics, Inc. devices

Submission Details

510(k) Number K873726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1987
Decision Date January 27, 1988
Days to Decision 134 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
46d slower than avg
Panel avg: 88d · This submission: 134d
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 K873726.
CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE
K914167 · Eastman Kodak Company · Mar 1992
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