Cleared Traditional

K951584 - ALKALINE PHOSPHATASE (ALP/AMP) PROCEDUR...

K951584 is the FDA 510(k) clearance for ALKALINE PHOSPHATASE (ALP/AMP) PROCEDUR... by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K951584 · Sigma Diagnostics, Inc. · Chemistry device
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Aug 1995
Decision
127d
Days
Class 2
Risk

K951584 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 127 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K951584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1995
Decision Date August 11, 1995
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 88d · This submission: 127d
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
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