Cleared Special

K991127 - VARIANT II B-THALASSEMIA

K991127 is an FDA 510(k) clearance for VARIANT II B-THALASSEMIA, manufactured by Bio-Rad. The device is a Class 2 Hematology device with product code JPD cleared through the Special 510(k) pathway after a 69-day FDA review.

K991127 · Bio-Rad · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K991127

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.

JPD Device Classification - Class 2, Special Controls

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.
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
K020489 · Tosoh Medics, Inc. · May 2002
VARIANT BETA-THALASSEMIA SHORT PROGRAM
K924122 · Bio-Rad · Mar 1993
GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT
K924496 · Drew Scientific , Ltd. · Nov 1992
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
K991127 · VARIANT II B-THALASSEMIA
Download PDF FDA Summary Bio-Rad