Cleared Traditional

K051072 - BIO-RAD VARIANT NBS SICKLE CELL PROGRAM

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

K051072 · Bio-Rad Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K051072

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.

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 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 20
Devices cleared under the same product code (GKA) and FDA review panel - the closest regulatory comparables to K051072.
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
K082227 · Sebia · Mar 2009
CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
K052291 · Sebia · Jun 2006
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
K050709 · Wallac OY · Mar 2006
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