D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM

K060001 · Bio-Rad Laboratories, Inc. · LCP · Jan 20, 2006 · Hematology

Device Facts

• Record ID: K060001
• Device Name: D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: LCP · Hematology
• Decision Date: Jan 20, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The D-10TM Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System. For In Vitro Diagnostic Use. The Bio-Rad D-10™ Dual Program system is intended for the percent determination of hemoglobins A1c, A2 and F, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The Bio-Rad D-10™ Dual Program is intended for Professional Use Only. For in vitro diagnostic use. Measurement of the percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus, and measurement of the percent HbA2 and HbF are effective in screening of ß—thalassemias (i.e., hereditary hemolytic anemias characterized by decreased synthesis of one or more types of abnormal hemoglobin polypeptide chains). Detection of hemoglobin variants such as hemoglobins S, C, D and E by HPLC is effective in presumptive identification of these variants.

Device Story

The Bio-Rad D-10 Hemoglobin Testing System is a fully automated HPLC analyzer for whole blood samples. The new D-10 Rack Loader accessory enables continuous loading of up to 5 racks (50 samples total) into the system, replacing manual single-rack insertion. The system uses ion-exchange HPLC to separate and quantify hemoglobin fractions (A1c, A2, F) and detect variants. Operated by laboratory professionals in clinical settings, the system processes samples automatically. Output consists of quantitative area percentages for specific hemoglobins, which are used by clinicians to monitor diabetes and screen for hemoglobinopathies. The system provides automated sample preparation and analysis, improving throughput for mid-size laboratories.

Clinical Evidence

Bench testing only. Validation protocols addressed hazards identified in the risk analysis (FMEA). Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Automated ion-exchange HPLC analyzer; 415 nm visible detection; EDTA whole blood sample type; software version 3.5; rack-based sample transport (5 racks of 10 tubes); standardized to DCCT/IFCC/NGSP for HbA1c; no higher-order reference method for HbA2/HbF.

Indications for Use

Indicated for monitoring long-term glucose control in individuals with diabetes mellitus (HbA1c), evaluation of ß-thalassemia (HbA2 and HbF), and presumptive identification of hemoglobin variants (S, C, D, E) in human whole blood.

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

• D-10 Hemoglobin A1c Program (K031043)
• D-10 Dual Program (K041444)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K060001

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I device. The following items are present and acceptable (delete/add items as necessary) for the D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM:

1. The name and 510(k) number of BIO-RAD LABORATORIES, INC.'s previously cleared device, BIO - RAD D-10 DUAL PROGRAM, cleared under K041444. (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 the addition of an optional D-10 Rack Loader to automatically run 5 racks of 10 specimens instead of the current 1 rack of 10 specimens

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

4. 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