Cleared Traditional

K923507 - ALKALINE PHOSPHATASE KIT

K923507 is the FDA 510(k) clearance for ALKALINE PHOSPHATASE KIT by Randox Laboratories, Ltd.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K923507 · Randox Laboratories, Ltd. · Chemistry device
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Dec 1992
Decision
141d
Days
Class 2
Risk

K923507 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE KIT. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on December 3, 1992 after a review of 141 days - within the typical 510(k) review window.

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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K923507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1992
Decision Date December 03, 1992
Days to Decision 141 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
53d slower than avg
Panel avg: 88d · This submission: 141d
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 83
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K923507.
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AMP ALKALINE PHOSPHATASE REAGENT KIT
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OLYMPUS ALKALINE PHOSPHATASE REAGENT
K925156 · Olympus Corp. · Nov 1992
EMDS ALKALINE PHOSPHATASE (ALP) TEST
K924574 · Em Diagnostic Systems, Inc. · Nov 1992
OLYMPUS ALKALINE PHOSPHATASE REAGENT
K923527 · Olympus Corp. · Sep 1992