Cleared Traditional

K915705 - ACID PHOSPHATASE REAGENT SET

K915705 is an FDA 510(k) clearance for ACID PHOSPHATASE REAGENT SET, manufactured by Tech Intl. Co.. The device is a Class 2 Chemistry device with product code CKE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K915705 · Tech Intl. Co. · Chemistry device
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Feb 1992
Decision
90d
Days
Class 2
Risk

K915705 is an FDA 510(k) clearance for the ACID PHOSPHATASE REAGENT SET. Classified as Acid Phosphatase, Thymolphthale Inmonophosphate (product code CKE), Class II - Special Controls.

Submitted by Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on February 27, 1992 after a review of 90 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 Tech Intl. Co. devices

FDA 510(k) Submission Details - K915705

510(k) Number K915705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1991
Decision Date February 27, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
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 8
Devices cleared under the same product code (CKE) and FDA review panel - the closest regulatory comparables to K915705.
CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE
K914167 · Eastman Kodak Company · Mar 1992
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