Cleared Traditional

K924813 - VARIANT SICKLE CELL SHORT PROGRAM

K924813 is an FDA 510(k) clearance for VARIANT SICKLE CELL SHORT PROGRAM, manufactured by Bio-Rad. The device is a Class 2 Hematology device with product code GKA cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K924813 · Bio-Rad · Hematology device
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Jan 1993
Decision
111d
Days
Class 2
Risk

K924813 is an FDA 510(k) clearance for the VARIANT SICKLE CELL SHORT PROGRAM. Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on January 14, 1993 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7415 - 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.

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FDA 510(k) Submission Details - K924813

510(k) Number K924813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1992
Decision Date January 14, 1993
Days to Decision 111 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 113d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKA Device Classification - Class 2, Special Controls

Product Code GKA Abnormal Hemoglobin Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7415
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 - GKA Abnormal Hemoglobin Quantitation

All 20
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K924813.
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
K955355 · Bio-Rad · Apr 1996
PRIMUS VARIANT SYSTEM PVS99
K955283 · Primus Corp. · Mar 1996
VARIANT HEMOGLOBINOPATHY PROGRAM
K954048 · Bio-Rad · Nov 1995
PARAGON ACID HEMOGLOBIN REAGENT KIT
K834595 · Beckman Instruments, Inc. · May 1984
RESOLVE-HB
K840011 · Isolab, Inc. · Feb 1984
ISOPROPANOL HEMOGLOBIN STABILITY TEST
K822123 · Helena Laboratories · Aug 1982