Cleared Traditional

ALKALINE PHOSPHATASE REAGENT SYSTEM (K952746) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 32
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K952746.
ALKP
K981806 · Abbott Laboratories · Jun 1998
ALKALINE PHOSPHATASE (ALKP)
K981245 · Abbott Laboratories · May 1998
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
K954840 · Sigma Diagnostics, Inc. · Feb 1996
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
K951584 · Sigma Diagnostics, Inc. · Aug 1995
EMDS ALKANINE PHOSPHATASE (ALP) TEST
K935182 · Em Diagnostic Systems, Inc. · Dec 1993
EMDS ALKALINE PHOSPHATASE (ALP) TEST
K924574 · Em Diagnostic Systems, Inc. · Nov 1992