Cleared Traditional

G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (K024006) - FDA 510(k) Clearance

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

K024006 · Pointe Scientific, Inc., · Chemistry device
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Mar 2003
Decision
117d
Days
Class 2
Risk

K024006 is an FDA 510(k) clearance for the G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE. Classified as Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening (product code JBF), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on March 31, 2003 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7360 - 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K024006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2002
Decision Date March 31, 2003
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 88d · This submission: 117d
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 Chemistry 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 K024006.
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