Cleared Traditional

K903995 - NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT (FDA 510(k) Clearance)

Class I Pathology device.

K903995 · Sigma Chemical Co. · Pathology device
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Dec 1990
Decision
106d
Days
Class 1
Risk

K903995 is an FDA 510(k) clearance for the NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT. Classified as Test, Leukocyte Alkaline Phosphatase (product code GHD), Class I - General Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on December 13, 1990 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.7660 - the FDA pathology device 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K903995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date December 13, 1990
Days to Decision 106 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 77d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GHD Test, Leukocyte Alkaline Phosphatase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.7660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.