Cleared Traditional

BINAXNOW G6PD TEST (K080003) - FDA 510(k) Clearance

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

K080003 · Binax, Inc. · Hematology device
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Oct 2008
Decision
295d
Days
Class 2
Risk

K080003 is an FDA 510(k) clearance for the BINAXNOW G6PD TEST. Classified as Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening (product code JBF), Class II - Special Controls.

Submitted by Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on October 23, 2008 after a review of 295 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Binax, Inc. devices

Submission Details

510(k) Number K080003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2008
Decision Date October 23, 2008
Days to Decision 295 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
182d slower than avg
Panel avg: 113d · This submission: 295d
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.

Regulatory Peers - JBF Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening

Devices cleared under the same product code (JBF) and FDA review panel - the closest regulatory comparables to K080003.
FINDER G6PD
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