Cleared Traditional

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT (K924496) - FDA 510(k) Clearance

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

K924496 · Drew Scientific , Ltd. · Hematology device
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Nov 1992
Decision
73d
Days
Class 2
Risk

K924496 is an FDA 510(k) clearance for the GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT. Classified as Hemoglobin A2 Quantitation (product code JPD), Class II - Special Controls.

Submitted by Drew Scientific , Ltd. (London W4 4ph Uk, GB). The FDA issued a Cleared decision on November 16, 1992 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Drew Scientific , Ltd. devices

Submission Details

510(k) Number K924496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1992
Decision Date November 16, 1992
Days to Decision 73 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 113d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPD Hemoglobin A2 Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7400
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 - JPD Hemoglobin A2 Quantitation

All 12
Devices cleared under the same product code (JPD) and FDA review panel - the closest regulatory comparables to K924496.
VARIANT II B-THALASSEMIA
K991127 · Bio-Rad · Jun 1999
VARIANT BETA-THALASSEMIA SHORT PROGRAM
K924122 · Bio-Rad · Mar 1993
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
K923317 · Helena Laboratories · Aug 1992
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
K923318 · Helena Laboratories · Aug 1992
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
K913384 · Helena Laboratories · Dec 1991
HEMOGLOBIN A2 MICRO COLUMN TEST
K896168 · Bio-Rad · Jan 1990