VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
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 |
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 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)
{0}------------------------------------------------
K140801
JUN 2 5 2014
:
# Special 510(k) Summary – Device Modification
| Introduction | This 510(k) summary is being submitted in accordance with the requirements of 21 CFR<br>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 III<br>(510)741-6265 | | | | | | |
| Date<br>Submitted | April 23, 2014 | | | | | | |
| Device Name | VARIANT™ II TURBO Link Hemoglobin A1c Program | | | | | | |
| Classification | Glycosylated hemoglobin assay, 21 CFR 864.7470 [LCP] | | | | | | |
| Predicate<br>Device | Table 1: Predicate Device<br>rumber<br>VARIANTIM II TURBO Link Hemoglobin<br>K070819<br>21 CFR 864.7470 [LCP] | | | | | | |
| Intended and<br>Indications for<br>Use | Alc Program<br>The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is intended for the<br>percent determination of hemoglobin Alc in human whole blood using ion-exchange<br>high-performance liquid chromatography (HPLC).<br>The VARIANT II TURBO Link Hemoglobin Alc Program is for use with the<br>VARIANT II TURBO Link Hemoglobin Testing System interfaced with an automated<br>sample transport system.<br>The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is Professional Use<br>Only.<br>Measurement of hemoglobin Alc is effective in monitoring long-term glycemic control<br>in individuals with diabetes mellitus. | | | | | | |
| | | | | | | | |
Bio-Rad Laboratories, Inc. VARIANT™ II TURBO Link Hemoglobin A1c Program Special 510(k) – Device Modification
{1}------------------------------------------------
Description of The VARIANT II TURBO Link Hemoglobin Testing System is the next generation Instrument VARIANT II TURBO Hemoglobin Testing System. It integrates the VARIANT II TURBO with the Sysmex HST-N (Hematology Sample Transportation)/XN-9000 TLA systems to allow management of patient sample tubes with A 1c order on the same platform. The VARIANT II TURBO Link system communicates with the Sysmex HST-N/XN-9000 TLA hardware and software in order to receive, identify, inject, and analyze samples with an A 1 c order.
> The VARIANT II TURBO Link Hemoglobin Testing System is a fully automated, highthroughput hemoglobin analyzer. It consists of three modules - the VARIANT II TURBO Link Chromatographic Station (VCS), the VARIANT II TURBO Link Sampling Station (VSS), and the Reagent Reservoir Module. In addition, a personal computer (PC) is used to control the VARIANT II TURBO Link system using Clinical Data Management (CDM™) software.
# Table 2: FDA-cleared assays for use on the VARIANT II TURBO Link Hemoglobin Testing System with CDM Software
| VARIANT II<br>TURBO Link<br>Assay | Assay<br>Part No. | Component Names and Part Nos. | Explanation of Test |
|-------------------------------------------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VARIANT II<br>TURBO Link<br>Hemoglobin<br>A1c Program | 270-2716 | The assay contains the following components Whole Blood Primer, 270-0352, 270-<br>0351, 270-0352 Elution Buffer A, 270-2717 Elution Buffer B, 270-2718 Wash/Diluent Solution, 270-2729 CD-ROM, 270-2719 Cartridge Set, 270-22724 Sample Vials, 270-2149 Calibrator/Diluent Set Additional Required/Available components: Wash/Diluent Solution Set, 270-2730 Elution Buffer A Set Prefilters, 270-2713 Stainless Steel Prefilter Adapters, 270-<br>2465 Microvial Adapters, 270-2720, 270-2721 | The VARIANT II TURBO Link<br>Hemoglobin A1c Program is a<br>well established method of<br>measuring the level of<br>Hemoglobin A1c in red blood<br>cells. Therapy for diabetes<br>requires the long-term<br>maintenance of a blood glucose<br>level as close as possible to<br>normal levels to minimize the<br>risk of long-term vascular<br>consequences. |
The following table shows the similarities and differences between the predicate and Comparison to Predicate modified device. Device
Table 3: VARIANT II TURBO Link Hemoglobin A1c Program
| Feature | Predicate: | Modified device |
|--------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| | Bio-Rad VARIANT TM II TURBO<br>Link Hemoglobin A1c Program<br>K070819 | Bio-Rad VARIANT TM II TURBO Link<br>Hemoglobin A1c Program<br>K140801 |
| Similarities | | |
| Technology | Ion-exchange high performance liquid chromatography | |
| Sample type | Anticoagulated whole blood (EDTA) | |
Bio-Rad Laboratories, Inc.
VARIANT™ II TURBO Link Hemoglobin A1c Program Special 510(k) - Device Modification
{2}------------------------------------------------
| Feature | Predicate:<br>Bio-Rad VARIANT TM II TURBO<br>Link Hemoglobin A1c Program<br>K070819 | Modified device:<br>Bio-Rad VARIANTTM II TURBO Link<br>Hemoglobin A1c Program<br>K140801 | | | | | | | | | | | | | |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Calibrator | Human anticoagulated whole blood treated with EDTA | | | | | | | | | | | | | | |
| Certification | Certified by the NGSP as traceable to the Diabetes Control and Complications Trial<br>(DCCT) Reference method. | | | | | | | | | | | | | | |
| Instrument Control | Windows Operating System with Proprietary Assay Software | | | | | | | | | | | | | | |
| Kit configuration | 1600 Tests: Whole Blood Primer (6 vials), Elution Buffer A (1 each), Elution Buffer<br>B (1 each), Calibrator/Diluent Set (1 each), CD-ROM (1 each), Cartridge Set (1 each),<br>Sample vials – package of 100 (2 each), Wash/Diluent Solution (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 | | | | | | | | | | | | | | |
| Intended Use | The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is intended for<br>the percent determination of hemoglobin A1c in human whole blood using ion-<br>exchange high-performance liquid chromatography (HPLC).<br><br>The VARIANT II TURBO Link Hemoglobin A1c Program is for use with the<br>VARIANT II TURBO Link Hemoglobin Testing System interfaced with an automated<br>sample transport system.<br><br>The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is for<br>Professional Use Only. | | | | | | | | | | | | | | |
| Performance Claims | No change, claims transferred from predicate device. | | | | | | | | | | | | | | |
| Differences | | | | | | | | | | | | | | | |
| CDM Software | CDM Software version 4.1 | CDM Software version 5.2.1 | | | | | | | | | | | | | |
| Reporting Units | %HbA1c (NGSP) | % HbA1c (NGSP), mmol/mol HbA1c<br>(IFCC), or %HbA1c (JDS) | | | | | | | | | | | | | |
| Printing Options | Export text file to external printer | External printer and Export to PDF options | | | | | | | | | | | | | |
| VARIANT II TURBO<br>Link Testing System<br>Firmware | EPROM<br>VCS 41.507<br>VSS 51.505<br>VSS PUMP<br>4.50 | EPROM &n FLASH N/A HST FLASH<br>VCS 42.507<br>VSS 52.815<br>VSS Pump<br>5.0 XN 9000 FLASH<br>VTCS 42.507<br>VTSS 52.815<br>VTSS PUMP<br>5.00 Automated Sampling<br>Station Sysmex HST Trackline Sysmex HST or Sysmex XN-9000<br>Trackline Historical Database<br>Review N/A Archive Viewer – this tool does not allow<br>transmission to an LIS, and is not intended | | | | | | | | | | | | | |
The software updates include customer requested features, whereas both software and Description of firmware include specific defect fixes. When compared to the predicate device, there Change are no changes to the performance specifications, intended or indications for use, or operating principles. Moreover, Risk Analysis and Verification/Validation testing results demonstrate that the changes do not affect product safety, effectiveness, and substantial equivalency claims.
Bio-Rad Laboratories, Inc. VARIANT™ II TURBO Link Hemoglobin A1c Program Special 510(k) - Device Modification
{3}------------------------------------------------
# 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. 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 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;
- 트 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;
- I 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 Link Hemoglobin A1c Program is substantially equivalent to the cleared and currently marketed predicate device.
Bio-Rad Laboratories. Inc. VARIANT™ II TURBO Link Hemoglobin A1c Program Special 510(k) - Device Modification
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Canirol Center - WO66-G609 Silver Spring, MD 20993-0002
BIO-RAD LABORATORIES, INC. EBONY MCKINNIES REGULATORY AFFAIRS REPRESENTATIVE III 4000 ALFRED NOBEL DR. HERCULES CA 94547
June 25, 2014
Re: K140801
Trade/Device Name: VARIANT™ II TURBO Link Hemoglobin A Ic Program Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP Dated: May 23, 2014 Received: May 27, 2014
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. Ilsting 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 is 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{5}------------------------------------------------
Page 2-Ms. McKinnies
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.lda.gov/MedicalDevices/Safety/ReportalProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
# Katherine Serrano -S
For : Courtney H. Lias
Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
#### 510(k) Number (if known) K 140801
#### Device Name
VARIANT™ II TURBO Link Hemoglobin A Ic Program
Indications for Use (Describe)
The Bio-Rad VARIANT II TURBO Link Hemoglobin Alc 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 A Ic 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 AIc Program is Professional Use Only. Measurement of hemoglobin A Ic is effective in monitoring long-term glycemic control in individuals with diabetes mellitus.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
## PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
# Stayce Beck -S
