Cleared Special

K080911 - VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH (FDA 510(k) Clearance)

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K080911 · Bio-Rad Laboratories Inc., Clinical Systems Divisi · Hematology device
May 2008
Decision
30d
Days
Class 2
Risk

K080911 is an FDA 510(k) clearance for the VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SY.... Classified as Abnormal Hemoglobin Quantitation (product code GKA), Class II - Special Controls.

Submitted by Bio-Rad Laboratories Inc., Clinical Systems Divisi (Hercules, US). The FDA issued a Cleared decision on May 2, 2008 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K080911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2008
Decision Date May 02, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
175d faster than avg
Panel avg: 205d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.