Cleared Traditional

K954048 - VARIANT HEMOGLOBINOPATHY PROGRAM

K954048 is the FDA 510(k) clearance for VARIANT HEMOGLOBINOPATHY PROGRAM by Bio-Rad. It is a Class 2 Hematology device (product code GKA) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K954048 · Bio-Rad · Hematology device
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Nov 1995
Decision
84d
Days
Class 2
Risk

K954048 is an FDA 510(k) clearance for the VARIANT HEMOGLOBINOPATHY 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 November 20, 1995 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K954048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1995
Decision Date November 20, 1995
Days to Decision 84 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
29d faster than avg
Panel avg: 113d · This submission: 84d
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 K954048.
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
K171664 · Bio-Rad Laboratories, Inc. · Sep 2017
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 SICKLE CELL SHORT PROGRAM
K924813 · Bio-Rad · Jan 1993
PARAGON ACID HEMOGLOBIN REAGENT KIT
K834595 · Beckman Instruments, Inc. · May 1984
RESOLVE-HB
K840011 · Isolab, Inc. · Feb 1984