MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM

K063643 · Bio-Rad Laboratories Inc., Clinical Systems Divisi · LCP · Dec 27, 2006 · Hematology

Device Facts

• Record ID: K063643
• Device Name: MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
• Applicant: Bio-Rad Laboratories Inc., Clinical Systems Divisi
• Product Code: LCP · Hematology
• Decision Date: Dec 27, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The VARIANT II 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 Hemoglobin Alc Program is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use. The VARIANT II Beta thalassemia Short Program is intended for the separation and area percent determinations of hemoglobin A2 and F, and as an aid in the identification of abnormal hemoglobins in human whole blood using ionexchange high-performance liquid chromatography (HPLC). The VARIANT II Beta-thalassemia Short Program is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use. The VARIANT II Total GHb Program is intended for the separation and area percent determination of total glycated hemoglobin (GHb) in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The VARIANT II Total GHb Program with is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use.

Device Story

Variant II system performs hemoglobin A1c, beta-thalassemia, and total GHB analysis; utilizes ion-exchange high-performance liquid chromatography (HPLC). Modification involves software upgrade for Clinical Data Management (CDM) from Windows NT (v3.6T) to Windows XP (v4.0). Data analysis algorithms transitioned from base CDM software integration to external software module. System used in clinical laboratory settings by trained technicians. Output provides quantitative analysis of hemoglobin variants/GHB for clinical diagnostic decision-making.

Clinical Evidence

Bench testing only. Validation protocols performed to address hazards identified in FMEA risk analysis; results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Ion-exchange HPLC system. Software-controlled data management. Modification: CDM software migration from Windows NT (v3.6T) to Windows XP (v4.0). Data analysis algorithms moved to external software module.

Indications for Use

Indicated for use in the Variant II: Hemoglobin A1c Program, Beta-Thalassemia Short Program, and Total GHB Program for clinical laboratory analysis.

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: Hemoglobin A1c Program (K984268)
• Beta-Thalassemia Short Program (K991127)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k063643

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 Modification To Variant II: Hemoglobin A1c Program, Beta-Thalassemia Short Program And Total GHB Program:

1. The name and 510(k) number of Bio-Rad Laboratories Inc., previously cleared device, Variant II: Hemoglobin A1c Program, Beta-Thalassemia Short Program, cleared under k984268 and k991127. (For a preamendments device, a statement to this effect has been provided.)

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 a software version change for the Clinical Data Management (CDM) from Windows NT (ver. 3.6T) to Windows XP (ver. 4.0). Additionally data analysis algorithms are complied in an external software module and not programmed into the base CDM software as in 3.6T.

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.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA)

revised:3/27/98