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

Intended 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) Summary – Device Modification

| Introduction | This 510(k) summary is being submitted in accordance with the requirements of<br>21 CFR 807.92 and the Safe Medical Device Act of 1990. | | | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|--------------------------------|--|--|
| Submitter | Bio-Rad Laboratories, Inc.<br>Clinical Systems Division<br>4000 Alfred Nobel Drive<br>Hercules, CA 94545 | | | | |
| Contact<br>Person | Ebony McKinnies<br>Regulatory Affairs Representative | | | | |
| Date<br>Submitted | April 5, 2013 | | | | |
| Device Name | VARIANT™ II TURBO HbA Ic Kit - 2.0, Catalog No.: 270-2455 | | | | |
| Classification | Glycosylated hemoglobin assay, 21 CFR 864.7470 [LCP] | | | | |
| Predicate | Table 1: Predicate Device | | | | |
| Device | Device Name | 510(k)<br>Number | Product Regulation and<br>Code | | |
| | VARIANT™ II TURBO HbAlc Kit - 2.0 | K122472 | 21 CFR 864.7470 [LCP] | | |
| Intended and<br>Indications<br>for Use | The Bio-Rad VARIANT™ II TURBO HbA Ic Kit - 2.0 is intended for the<br>quantitative determination of hemoglobin Alc in human whole blood using ion-<br>exchange high performance liquid chromatography (HPLC) on the VARIANT II<br>TURBO Hemoglobin Testing System. Measurement of hemoglobin Alc is<br>effective in monitoring long term glycemic control in individuals with diabetes<br>mellitus. The Bio-Rad VARIANT II TURBO HbAlc Kit - 2.0 is intended for<br>professional Use. | | | | |
| Description of<br>Change | The software updates include customer requested features, whereas both software<br>and firmware include specific defect fixes. When compared to the predicate<br>device, there are no changes to the performance specifications, intended or<br>indications for use, or operating principles. Moreover, Risk Analysis and<br>Verification/Validation testing results demonstrate that the changes do not affect<br>product safety, effectiveness, and substantial equivalency claims. | | | | |

Bio-Rad Laboratories, Inc. VARIANT™ II TURBO HbAlc Kit – 2.0 Special 510(k) - Device Modification

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The VARIANT II TURBO Hemoglobin Testing System is the next generation Description of HPLC system with higher volume capability when compared to the VARIANT II Instrument testing system. The VARIANT II TURBO Hemoglobin Testing System provides an integrated method for sample preparation, separation, and determination of specific hemoglobin in whole blood. It is a fully automated, high-throughput system. It consists of 2 modules: the VARIANT II TURBO Sampling Station (VSS) and the VARIANT II TURBO Chromatographic Station (VCS).

> A personal computer (PC) is used to control the VARIANT II TURBO System using Clinical Data Management (CDM™) software. The CDM software supports import of sample information from and export of patient results to a Laboratory Information System (LIS). Control results are displayed on Levy-Jennings Charts and are exportable to Unity Real Time™.

| VARIANT II<br>TURBO Assay | Assay Part<br>No. | Component Names and Part Nos. | Explanation of Test |
|-------------------------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VARIANT II<br>TURBO<br>HbA1c Kit –<br>2.0 | 270-2455 | The assay contains the following<br>components – Whole Blood Primer, 270-0350,<br>270-0351, 270-0352 Elution Buffer A, 270-2456 Elution Buffer B, 270-2457 Calibrator/Diluent Set, 270-2458 CD-ROM, 270-2461 Analytical Cartridge, 270-2462 Sample Vials, 270-2149 Additional Required/Available<br>components: Wash/Diluent Solution Set, 270-<br>2730 Cartridge Holder Installation Kit,<br>270-2463 Prefilters, 270-2464 Stainless Steel Prefilter Adapters,<br>270-2465 Microvial Adapters, 270-2016-10 | The VARIANT II<br>TURBO HbA1c Kit<br>– 2.0 is a well<br>established method of<br>measuring the level<br>of Hemoglobin A1c<br>in red blood cells.<br>Therapy for diabetes<br>requires the long-<br>term maintenance of<br>a blood glucose level<br>as close as possible to<br>normal levels to<br>minimize the risk of<br>long-term vascular<br>consequences. |

## Table 2: FDA-cleared assays for use on the VARIANT II TURBO Hemoglobin Testing System with CDM Software

Comparison to Predicate Device

The following table shows the similarities and differences between the predicate and modified device.

Bio-Rad Laboratories, Inc. VARIANT™ II TURBO HbAlc Kit - 2.0 Special 510(k) -- Device Modification

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## Table 3: VARIANT II TURBO HbA1c Kit – 2.0

| Feature | Predicate:<br>Bio-Rad VARIANT™ II TURBO<br>HbA1c Kit -2.0, 510(k) 122472 | Modified device:<br>Bio-Rad VARIANT™ II TURBO HbA1c<br>Kit -2.0 |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Technology | Ion-exchange high performance liquid chromatography | |
| Sample type | Anticoagulated whole blood (EDTA) | |
| Calibrator | Human anticoagulated whole blood treated with EDTA | |
| Calibration<br>frequency | Once every 500 injections/ 2500 injections total column life | |
| Certification | Certified by the NGSP as traceable to the Diabetes Control and Complications<br>Trial (DCCT) Reference method. | |
| Certification | Certified by the IFCC as traceable to the IFCC Reference Measurement<br>Procedure. | |
| Instrument Control | Windows Operating System with Proprietary Assay Software | |
| Kit configuration | 2500 Tests: Whole Blood Primer (2 each), Elution Buffer A (5 each),<br>Elution B (1 each), Calibrator/Diluent Set (1 each), CD-ROM (1 each),<br>Analytical Cartridge (1 each), Sample Vials – package of 100 (1 each). | |
| Chemistry | Cation Exchange Matrix | |
| Safety Standards for<br>Electrical Equipment<br>for IVD Use | BS EN 61010 Certified | |
| Electromagnetic<br>Compatibility | BS EN 61326 Certified | |
| Reporting units | % HbA1c (NGSP), mmol/mol HbA1c (IFCC), or %HbA1c (JDS) | |
| Intended Use | Intended for the quantitative determination of HbA1c in human whole blood<br>using ion-exchange HPLC on the VARIANT II TURBO Hemoglobin Testing<br>System. Measurement of percent HbA1c is effective in monitoring long-term<br>glucose control in individuals with diabetes mellitus. | |
| Performance Claims | No change, claims transferred from predicate device. | |
| Differences | | |
| CDM Software | CDM Software version 5.1.1 | CDM Software version 5.2 |
| | EPROM | FLASH |
| VARIANT II<br>TURBO Testing<br>System Firmware | VCS 41.507<br>VSS 51.505<br>VSS PUMP 4.50 | VCS 42.507<br>VSS 52.523<br>VSS PUMP 5.00 |
| Historical Database<br>Review | N/A | Archive Viewer - this tool does not<br>allow transmission to an LIS, and is not<br>intended for repeat reporting. |

Risk Management Process for Device Modifications

In accordance with ISO 14971:2012, and internal risk management processes and procedures a defined risk analysis was used to identify, mitigate, or eliminate potential risks associated with the device modifications. For each identified risk, a Failure Mode and Effects Analysis (FMEA) was conducted. This was performed in a systematic manner by a trained risk assessment team until consensus was reached that an adequate analysis had been performed.

Bio-Rad Laboratories, Inc. VARIANT™ II TURBO HbAlc Kit - 2.0 Special 510(k) - Device Modification

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The risk evaluation for the device software and firmware modifications included the following tasks:

- Reviewed modifications and design inputs to identify potential risks and . hazards:
- Reviewed existing product risk tables and customer complaints to 그 identify potential risks and hazards;
- Considered requirements of IEC 62304:2009, Software Design and . Development processes and plan to identify potential risks and hazards;
- Identified and implemented risk mitigations and hazard controls through . software, hardware, and labeling for misuse and use scenarios;
- . Updated existing FMEA and Hazard Analysis tables with newly identified risks, software defects, residual risks, mitigations and hazard controls:
- . Evaluated modified product using established verification and validation processes, plans and protocols with appropriate acceptance criteria that determined whether risk mitigations, hazard controls, and residual risks were as safe and effective as the predicate device;
- . Conducted a comprehensive risk management review and wrote a Risk Management Report that summarized all risk activities and deemed the modified product safe, effective, and comparable to the predicate device.

Design verification/validation tests met established acceptance criteria.

Conclusion

When considering the similarities of the intended use, general features and characteristics of the assay, and use of the same technology, it can be concluded that the VARIANT II TURBO HbA1c Kit - 2.0 is substantially equivalent to the cleared and currently marketed predicate device.

Bio-Rad Laboratories, Inc. VARIANT™ II TURBO HbA1c Kit – 2.0 Special 510(k) - Device Modification

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 9, 2013

Bio-Rad Laboratories, Inc. C/O Ms. Ebony McKinnies 4000 Alfred Nobel Drive HERCULES CA 94547-1803

Re: K130990

Trade/Device Name: VARIANT™ II TURBO HbA1c Kit - 2.0 Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP Dated: April 05, 2013 Received: April 10, 2013

Dear Ms. McKinnies:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol G. Benson - S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics - and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

510(k) Number (if known): k130990

Device Name: VARIANT™ II TURBO HbA1c Kit - 2.0

Indications for Use:

The Bio-Rad VARIANT II TURBO HbA1c Kit – 2.0 is intended for the quantitative determination of hemoglobin A1c in human whole blood using ionexchange high performance liquid chromatography (HPLC) on the VARIANT II TURBO Hemoglobin Testing System. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The Bio-Rad VARIANT II TURBO HbA1c Kit - 2.0 is intended for Professional Use Only.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiologic Health (OIR)

Ruth A. Chesler S.

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) k130990

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