Cleared Traditional

BIO-RAD VARIANT NBS SICKLE CELL PROGRAM (K051072) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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 Peers - GKA Abnormal Hemoglobin Quantitation

All 22
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K171664 · Bio-Rad Laboratories, Inc. · Sep 2017