Cleared Traditional

K924813 - VARIANT SICKLE CELL SHORT PROGRAM

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

K924813 · Bio-Rad · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Bio-Rad devices

Submission Details

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.

Device Classification

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 13
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K924813.
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
K051072 · Bio-Rad Laboratories, Inc. · May 2005
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
K955355 · Bio-Rad · Apr 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