Cleared Traditional

K933934 - GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A (FDA 510(k) Clearance)

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

K933934 · Sigma Diagnostics, Inc. · Hematology device
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Jun 1995
Decision
687d
Days
Class 2
Risk

K933934 is an FDA 510(k) clearance for the GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A. Classified as Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening (product code JBF), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 29, 1995 after a review of 687 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7360 - the FDA hematology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

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Submission Details

510(k) Number K933934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1993
Decision Date June 29, 1995
Days to Decision 687 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
574d slower than avg
Panel avg: 113d · This submission: 687d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBF Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7360
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 Hematology devices follow this clearance model.