Cleared Traditional

K080003 - BINAXNOW G6PD TEST

K080003 is an FDA 510(k) clearance for BINAXNOW G6PD TEST, manufactured by Binax, Inc.. The device is a Class 2 Hematology device with product code JBF cleared through the Traditional 510(k) pathway after a 295-day FDA review.

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

FDA 510(k) Submission Details - K080003

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
Combination Product No
PCCP Authorized No
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.

JBF Device Classification - Class 2, Special Controls

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
K201049 · Baebies, Inc. · Sep 2022
BinaxNOW G6PD Test
K161364 · Alere Scarborough, Inc. · Jun 2016
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
K024006 · Pointe Scientific, Inc., · Mar 2003
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
K933934 · Sigma Diagnostics, Inc. · Jun 1995