Cleared Traditional

K952746 - ALKALINE PHOSPHATASE REAGENT SYSTEM

K952746 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE REAGENT SYSTEM, manufactured by Medical Diagnostic Technologies, Inc.. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K952746 · Medical Diagnostic Technologies, Inc. · Chemistry device
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Nov 1995
Decision
164d
Days
Class 2
Risk

K952746 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE REAGENT SYSTEM. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on November 27, 1995 after a review of 164 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 Medical Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K952746

510(k) Number K952746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1995
Decision Date November 27, 1995
Days to Decision 164 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
76d slower than avg
Panel avg: 88d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJE Device Classification - Class 2, Special Controls

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 116
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K952746.
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ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
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K942997 · Prisma Systems · Dec 1994
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