VARIANT(TM) II TURBO HBA1C KIT - 2.0

K130990 · Bio-Rad Laboratories, Inc., Clinical Systems Divis · LCP · May 9, 2013 · Hematology

Device Facts

• Record ID: K130990
• Device Name: VARIANT(TM) II TURBO HBA1C KIT - 2.0
• Applicant: Bio-Rad Laboratories, Inc., Clinical Systems Divis
• Product Code: LCP · Hematology
• Decision Date: May 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The Bio-Rad VARIANT™ II TURBO HbA Ic Kit - 2.0 is intended for the quantitative determination of hemoglobin Alc in human whole blood using ion-exchange high performance liquid chromatography (HPLC) on the VARIANT II TURBO Hemoglobin Testing System. Measurement of hemoglobin Alc is effective in monitoring long term glycemic control in individuals with diabetes mellitus. The Bio-Rad VARIANT II TURBO HbAlc Kit - 2.0 is intended for professional Use.

Device Story

VARIANT™ II TURBO HbA1c Kit – 2.0; in vitro diagnostic device for HbA1c measurement. Modification involves firmware and software updates; includes customer-requested features, defect corrections, and functionality/ease-of-use upgrades. Fundamental scientific technology remains unchanged from predicate. Device operates via automated laboratory analysis; results used by clinicians for glycemic control monitoring. Modification verified through design control activities, risk analysis, and validation testing.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control procedures to confirm software/firmware modifications met predetermined acceptance criteria.

Technological Characteristics

Ion-exchange HPLC; cation exchange matrix. System components: VSS and VCS modules. Connectivity: PC-based, LIS integration via CDM software. Standards: BS EN 61010 (electrical safety), BS EN 61326 (EMC). Calibration: NGSP/IFCC traceable. Software: CDM v5.2, FLASH memory.

Indications for Use

Indicated for quantitative determination of HbA1c in human whole blood for monitoring long-term glycemic control in individuals with diabetes mellitus. For professional use only.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Predicate Devices

• VARIANT™ II TURBO HbAlc Kit - 2.0 (K122472)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K130990

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the VARIANT™ II TURBO HbA1c Kit – 2.0:

1. The name and 510(k) number of Bio-Rad Laboratories' previously cleared device VARIANT™ II TURBO HbA1c Kit – 2.0, cleared under K122472.

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.

3. A description of the device MODIFICATION (S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for version modifications associated with firmware and software improvements only, which include customer requested features, defect corrections, ease-of-use and functionality upgrades.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.