VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM

K140801 · Bio-Rad Laboratories, Inc. · LCP · Jun 25, 2014 · Hematology

Device Facts

• Record ID: K140801
• Device Name: VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: LCP · Hematology
• Decision Date: Jun 25, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The VARIANT II TURBO Link Hemoglobin A1c Program is for use with the VARIANT II TURBO Link Hemoglobin Testing System interfaced with an automated sample transport system. The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is Professional Use Only. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus.

Device Story

The VARIANT™ II TURBO Link Hemoglobin A1c Program is an automated system for the measurement of Hemoglobin A1c in human blood. The device modification involves software and firmware updates to improve usability, functionality, and address defect corrections. The system operates in a clinical laboratory setting, where it processes blood samples to provide quantitative results for clinical decision-making regarding glycemic control. The fundamental scientific technology remains unchanged from the predicate device.

Clinical Evidence

Bench testing only. Verification and validation protocols confirmed that software/firmware modifications met acceptance criteria and maintained performance specifications equivalent to the predicate device.

Technological Characteristics

Ion-exchange HPLC; cation exchange matrix. System modules: Chromatographic Station (VCS), Sampling Station (VSS), Reagent Reservoir. Connectivity: Interfaced with Sysmex HST-N/XN-9000 TLA. Electrical safety: BS EN 61010; EMC: BS EN 61326. Software: CDM v5.2.1.

Indications for Use

Indicated for the determination of hemoglobin A1c in human whole blood to monitor 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 Link Hemoglobin A1c Program (K070819)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K140801

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:

1. The name and 510(k) number of Bio-Rad Laboratories' previously cleared device VARIANT™ II TURBO Link Hemoglobin A1c Program, cleared under K070819.

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, system and software operations manuals.

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 software version modifications associated with firmware and software improvements, which include customer requested features, defect corrections, overall usability and functionality improvements.

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.