Cleared Traditional

K051072 - BIO-RAD VARIANT NBS SICKLE CELL PROGRAM

K051072 is the FDA 510(k) clearance for BIO-RAD VARIANT NBS SICKLE CELL PROGRAM by Bio-Rad Laboratories, Inc.. It is a Class 2 Hematology device (product code GKA) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K051072 · Bio-Rad Laboratories, Inc. · Hematology device
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May 2005
Decision
16d
Days
Class 2
Risk

K051072 is an FDA 510(k) clearance for the BIO-RAD VARIANT NBS SICKLE CELL PROGRAM. Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Hercules, US). The FDA issued a Cleared decision on May 12, 2005 after a review of 16 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.

View all Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K051072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2005
Decision Date May 12, 2005
Days to Decision 16 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 113d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

California Department of Health Services
ALFRED J QUATTRONE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GKA Abnormal Hemoglobin Quantitation

All 12
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K051072.
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
K192931 · Helena Laboratories, Corp. · Apr 2022
CAPI 3 HEMOGLOBIN(E)
K180762 · Sebia · Dec 2018
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
K171664 · Bio-Rad Laboratories, Inc. · Sep 2017
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
K955355 · Bio-Rad · Apr 1996
VARIANT HEMOGLOBINOPATHY PROGRAM
K954048 · Bio-Rad · Nov 1995
VARIANT SICKLE CELL SHORT PROGRAM
K924813 · Bio-Rad · Jan 1993