VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,

K070819 · Bio-Rad Laboratories Inc., Clinical Systems Divisi · LCP · Jun 25, 2007 · Hematology

Device Facts

• Record ID: K070819
• Device Name: VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
• Applicant: Bio-Rad Laboratories Inc., Clinical Systems Divisi
• Product Code: LCP · Hematology
• Decision Date: Jun 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended 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 for Professional Use Only. Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Device Story

System uses ion-exchange high-performance liquid chromatography (HPLC) to measure percent hemoglobin A1c in human anticoagulated whole blood (EDTA). Device integrates with external automated sample transport systems (e.g., Sysmex HST-N) for continuous feed, batch, or STAT processing of closed sample tubes. Reagents are identical to predicate. Professional use only in clinical laboratory settings. Output provides quantitative HbA1c percentage, aiding clinicians in monitoring long-term glucose control for diabetic patients. System performance is traceable to DCCT reference method and IFCC, and certified by NGSP.

Clinical Evidence

Bench testing only. Precision studies (n=80 per sample type) showed total CVs ranging from 0.92% to 1.74%. Linearity demonstrated across 4.1% to 17.6% HbA1c range (slope 1.0039, r=0.9996). Interference studies confirmed no significant impact from labile A1c, carbamylated hemoglobin, or HbF (up to 5%). Method comparison with predicate (n=202 total samples) showed high correlation (r=0.998-0.999).

Technological Characteristics

Cation exchange HPLC; utilizes analytical and guard cartridges. Energy source: electrical (analyzer/PC). Connectivity: networked with Sysmex HST-N automation via CDM 4.1 software. Dimensions: modular system (VCS, VSS, Reagent Reservoir). Sterilization: N/A (in vitro diagnostic). Software: CDM 4.1 for instrument control, data management, and results analysis.

Indications for Use

Indicated for monitoring long-term glucose control in individuals with diabetes mellitus via measurement of percent hemoglobin A1c 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

• VARIANT™ II TURBO Hemoglobin A1c Program (K040872)
• VARIANT™ II TURBO Hemoglobin A1c Program run on the VARIANT II TURBO Hemoglobin Testing System with CDM 4.0 (K063400)

Submission Summary (Full Text)

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K070819

JUN 2 5 2007

# Summary of Safety and Effectiveness for Bio-Rad Laboratories, Inc.

VARIANT™ II TURBO Link Hemoglobin A1c Program

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## Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

| Submitter: | Bio-Rad Laboratories, Inc.<br>Clinical Diagnostics Group<br>4000 Alfred Nobel Drive,<br>Hercules, California 94547<br>Phone: [phone]<br>FAX: [phone] |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jackie Buckley<br>Regulatory Affairs Representative |
| Date of Summary Preparation: | March 23, 2007 |
| Device Name: | VARIANT™ II TURBO Link Hemoglobin A1c Program |
| Classification Name: | Assay, Glycosylated Hemoglobin, 81LCP |
| Predicate Device(s): | VARIANT™ II TURBO Hemoglobin A1c Program<br>(k) 040872<br>Bio-Rad Laboratories, Inc.<br>VARIANT™ II TURBO Hemoglobin A1c Program run on the<br>VARIANT II TURBO Hemoglobin Testing System with CDM 4.0<br>(k) 063400<br>Bio-Rad Laboratories, Inc. |
| Intended Use: | The Bio-Rad VARIANT™ II TURBO Link Hemoglobin A1c<br>Program is intended for the percent determination of hemoglobin<br>A1c in human whole blood using ion-exchange high performance<br>liquid chromatography (HPLC).<br><br>The VARIANT II TURBO Link Hemoglobin A1c Program is for<br>use with the VARIANT II TURBO Link Hemoglobin Testing<br>System interfaced with an automated sample transport system.<br><br>The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program<br>is for Professional Use Only. |

Bio-Rad Laboratories, Inc.
VARIANT II TURBO Link Hemoglobin A1c Program
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Indications for Use:

Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

#### Description of the Device:

The VARIANT II TURBO Link Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The VARIANT II TURBO Link Hemoglobin A lc Program is based on chromatographic separation of Hemoglobin Alc on a cation exchange cartridge. The reagents in the VARIANT II TURBO Link Hemoglobin A 1c Program have the same formulation as the reagents in the VARIANT II TURBO Hemoglobin A1c Program.

#### Technical Characteristics Compared to the Predicate:

The VARIANT II TURBO Link Hemoglobin A1c Program and the predicate VARIANT II TURBO Hemoglobin Alc Program have the same technical characteristics that are summarized in the table below:

| Characteristics | VARIANT II TURBO Link<br>Hemoglobin A1c Program | VARIANT II TURBO Hemoglobin<br>A1c Program (k)040872 and<br>VARIANT II TURBO Hemoglobin<br>A1c Program run with<br>CDMTM 4.0(k) 063400 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte Measured: Reported | %Hemoglobin A1c | %Hemoglobin A1c |
| Intended Use | The Bio-Rad VARIANT II TURBO<br>Link hemoglobin A1c Program is<br>intended for the percent<br>determination of hemoglobin A1c in<br>human whole blood using ion-<br>exchange high-performance liquid<br>chromatography (HPLC).<br>The VARIANT II TURBO Link<br>Hemoglobin A1c Program is for use<br>with the VARIANT II TURBO<br>Link Hemoglobin Testing System<br>interfaced with an automated<br>sample transport system.<br>The Bio-Rad VARIANT II TURBO<br>link Hemoglobin A1c Program is<br>for Professional Use Only. | The Bio-Rad VARIANT II TURBO<br>Hemoglobin A1c Program is intended<br>for the percent determination of<br>hemoglobin A1c in human whole blood<br>using ion-exchange high performance<br>liquid chromatography (HPLC).<br>The Bio-Rad VARIANT II TURBO<br>Hemoglobin A1c Program is intended<br>for Professional Use Only. For In Vitro<br>Diagnostic Use. |
| Assay Principle | Cation exchange high performance<br>liquid chromatography | Cation exchange high performance<br>liquid chromatography |
| Reagents in kit | The reagent formulations are the<br>same as the predicate. In addition<br>Buffer A can be purchased as a<br>separate kit and Buffer B can be<br>purchased individually. | Kit contains Analytical cartridge,<br>Guard cartridge, Buffer A, Buffer B,<br>Wash/Diluent Solution Set (sold<br>separately), Whole Blood Primer, and<br>Calibrator/Diluent Set |

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| Characteristics | VARIANT II TURBO Link<br>Hemoglobin A1c Program | VARIANT II TURBO Hemoglobin<br>A1c Program (k)040872<br>and (k) 063400 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Type | Human anticoagulated whole blood<br>(EDTA) | Human anticoagulated whole blood<br>(EDTA) |
| Sample transport mode of<br>operation | Continuous feed, batch or STAT<br>mode of closed EDTA sample tubes<br>from automated sample transport<br>system. | Batch mode of closed EDTA sample<br>tubes |
| Automated sample transport<br>system | The VARIANT II TURBO Link<br>Hemoglobin Testing System<br>requires an external automated<br>sample transport system such as<br>the Sysmex® HST-N<br>(Hemoglobin Sample Transport)<br>System. | The VARIANT II TURBO<br>Hemoglobin Testing System is<br>complete with an automated sample<br>conveyor system. |
| Standardization | Traceable to the Diabetes Control<br>and Complications Trial (DCCT)<br>reference method and IFCC.<br>Certified via the National<br>Glycohemoglobin Standardization<br>Program (NGSP). | Traceable to the Diabetes Control and<br>Complications Trial (DCCT)<br>reference method and IFCC.<br>Certified via the National<br>Glycohemoglobin Standardization<br>Program (NGSP). |

#### Testing To Establish Substantial Equivalence:

#### Accuracy:

Method correlation between the VARIANT II TURBO Link Hemoglobin Alc Program and VARIANT II TURBO Hemoglobin A1c Program was evaluated using 180 EDTA whole blood patient samples ranging from 4.2% to 14.0% HbA1c. The results are presented in the following regression table.

| Regression<br>Method | n | R² | Slope | Intercept |
|----------------------|-----|-------|-------|-----------|
| Least Squares | 180 | 0.998 | 0.983 | 0.225 |

#### Precision:

The following table provides comparison data on the precision between the VARIANT II TURBO Link Hemoglobin Alc and VARIANT II TURBO Hemoglobin A1c Programs, each utilizing low and high EDTA whole blood patient samples, and both tested against samples with normal (6.0,6.2) and high (9.4,12.5) % A1c content.

Method precision was performed using a protocol based on the NCCLS Evaluation protocol, Vol.24, No. 25, EP5-A2 (2004) for the VARIANT II TURBO Link Hemoglobin A1c and VARIANT II TURBO Hemoglobin Alc Programs. The protocols for both the VARIANT II TURBO Link Hemoglobin A1c and VARIANT II TURBO Hemoglobin Alc Programs are similar.

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Using these protocols, 40 runs (2 per day) were performed on one VARIANT II TURBO Link (or VARIANT II TURBO) Hemoglobin Testing System over 20 working days. In each duplicate daily run, one aliquot of normal and one aliquot of diabetic patient samples were each analyzed per run.

Although the precision samples are different, since they were run at different time periods, the precision results between the VARIANT II TURBO Link Hemoglobin Alc and the VARIANT II TURBO Hemoglobin Alc Program are equivalent. A summary of combined comparative precision results is presented in the following precision table.

| VARIANT II TURBO Link Hemoglobin A1c Program | | VARIANT II TURBO Hemoglobin A1c Program | | |
|----------------------------------------------|------------------------|-----------------------------------------|------------------------|--------------------------|
| | Normal Patient (HbA1c) | Diabetic Patient (HbA1c) | Normal Patient (HbA1c) | Diabetic Patient (HbA1c) |
| n= (number of samples) | 80 | 80 | 80 | 80 |
| Mean | 6.01 | 9.43 | 6.2 | 12.5 |
| Within run (%CV) | 0.62 | 0.47 | 0.82 | 0.54 |
| Total Precision (%CV) | 1.27 | 0.92 | 1.94 | 2.58 |

#### VARIANT II TURBO Link Hemoglobin A1c and VARIANT II TURBO Hemoglobin A1c Precision

#### Linearity:

| | VARIANT II TURBO Link<br>Hemoglobin A1c Program | VARIANT II TURBO Hemoglobin<br>A1c Program |
|--------------|-------------------------------------------------|--------------------------------------------|
| Linear Range | 4.1 – 17.6 % HbA1c | 4.1 – 16.8 % HbA1c |

#### Conclusion:

When considering the similarities of the intended use, the general characteristics of the use of the same technology and the similar correlation, accuracy and linearity between the two methods, it can be concluded that the VARIANT II TURBO Link Hemoglobin A1c Program is substantially equivalent to the cleared and currently marketed predicate, VARIANT II TURBO Hemoglobin A10 Program.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 5 2007

Bio-Rad Laboratories, Inc. c/o Ms. Jackie H. Buckley 4000 Alfred Nobel Drive Hercules, CA 94547

k070819 Re: Trade Name: Variant II Turbo Link Hemoglobin Testing System Regulation Number: 21 CFR 864.7470 Glycosylated hemoglobin assay Regulation Name: Regulatory Class: Class II Product Code: LCP, KRZ Dated: March 23, 2007 Received: March 26, 2007

Dear Ms. Buckley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): k070819

Device Name: VARIANT II TURBO Link Hemoglobin A1c Program

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). Measurement of percent hemoglobin A 1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

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 intended for Professional Use Only.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Patricia Bernhardt
Division Sign-Off (for Carol Bensa)

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) k070819