Cleared Special

VARIANT II B-THALASSEMIA (K991127) - FDA 510(k) Clearance

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

K991127 · Bio-Rad · Hematology device
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Jun 1999
Decision
69d
Days
Class 2
Risk

K991127 is an FDA 510(k) clearance for the VARIANT II B-THALASSEMIA. Classified as Hemoglobin A2 Quantitation (product code JPD), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on June 10, 1999 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7400 - 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.

View all Bio-Rad devices

Submission Details

510(k) Number K991127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1999
Decision Date June 10, 1999
Days to Decision 69 days
Submission Type Special
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
44d faster than avg
Panel avg: 113d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JPD Hemoglobin A2 Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7400
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 - JPD Hemoglobin A2 Quantitation

All 12
Devices cleared under the same product code (JPD) and FDA review panel - the closest regulatory comparables to K991127.
VARIANT BETA-THALASSEMIA SHORT PROGRAM
K924122 · Bio-Rad · Mar 1993
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
K923317 · Helena Laboratories · Aug 1992
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
K923318 · Helena Laboratories · Aug 1992
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
K913384 · Helena Laboratories · Dec 1991
HEMOGLOBIN A2 MICRO COLUMN TEST
K896168 · Bio-Rad · Jan 1990
DETER. OF HEMOGLOBIN A2 USING THE DIAMAT
K875102 · Bio-Rad · Feb 1988