(86 days)
Not Found
No
The summary describes a fully automated HPLC system for measuring hemoglobin A1c. There is no mention of AI or ML in the device description, intended use, or performance studies. The system relies on established chromatographic principles and software for control and data management, not AI/ML algorithms for analysis or interpretation.
No.
The device is for the determination of hemoglobin A1c to monitor long-term glycemic control, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is intended for the "percent determination of hemoglobin A1c in human whole blood" and states that "Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus," which directly relates to diagnosing or monitoring a medical condition.
No
The device description clearly states it is a "Hemoglobin Testing System" consisting of hardware modules (Chromatographic Station, Sampling Station, Reagent Reservoir Module) controlled by software. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "percent determination of hemoglobin A1c in human whole blood". This involves testing a biological sample (whole blood) outside of the body (in vitro) to provide diagnostic information (monitoring long-term glycemic control in individuals with diabetes mellitus).
- Device Description: The device is described as a "fully automated, highthroughput hemoglobin analyzer" that analyzes samples. This aligns with the function of an IVD device.
- Professional Use Only: While not a definitive marker, IVDs are typically used by trained professionals in a laboratory or clinical setting, which is consistent with the "Professional Use Only" indication.
The information provided clearly indicates that this device is designed to perform diagnostic tests on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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).
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.
Product codes (comma separated list FDA assigned to the subject device)
LCP
Device Description
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 1c 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Use Only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk Analysis and Verification/Validation testing results demonstrate that the changes do not affect product safety, effectiveness, and substantial equivalency claims.
Design verification/validation tests met established acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.7470 Glycosylated hemoglobin assay.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
807.92 and the Safe Medical Device Act of 1990. | | | | | | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Submitter | Bio-Rad Laboratories, Inc.
Clinical Systems Division
4000 Alfred Nobel Drive
Hercules, CA 94545 | | | | | | |
| Contact
Person | Ebony McKinnies
Regulatory Affairs Representative III
(510)741-6265 | | | | | | |
| Date
Submitted | April 23, 2014 | | | | | | |
| Device Name | VARIANT™ II TURBO Link Hemoglobin A1c Program | | | | | | |
| Classification | Glycosylated hemoglobin assay, 21 CFR 864.7470 [LCP] | | | | | | |
| Predicate
Device | Table 1: Predicate Device
rumber
VARIANTIM II TURBO Link Hemoglobin
K070819
21 CFR 864.7470 [LCP] | | | | | | |
| Intended and
Indications for
Use | Alc Program
The Bio-Rad VARIANT II TURBO Link 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 VARIANT II TURBO Link Hemoglobin Alc 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 Alc is effective in monitoring long-term glycemic control
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
TURBO Link
Assay | Assay
Part No. | Component Names and Part Nos. | Explanation of Test |
|-------------------------------------------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VARIANT II
TURBO Link
Hemoglobin
A1c Program | 270-2716 | The assay contains the following components Whole Blood Primer, 270-0352, 270-
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-
2465 Microvial Adapters, 270-2720, 270-2721 | The VARIANT II TURBO Link
Hemoglobin A1c Program is a
well established method of
measuring the level of
Hemoglobin A1c in red blood
cells. Therapy for diabetes
requires the long-term
maintenance of a blood glucose
level as close as possible to
normal levels to minimize the
risk of long-term vascular
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 | ||
| Link Hemoglobin A1c Program | ||
| K070819 | Bio-Rad VARIANT TM II TURBO Link | |
| Hemoglobin A1c Program | ||
| 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:
Bio-Rad VARIANT TM II TURBO
Link Hemoglobin A1c Program
K070819 | Modified device:
Bio-Rad VARIANTTM II TURBO Link
Hemoglobin A1c Program
K140801 | | | | | | | | | | | | | |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Calibrator | Human anticoagulated whole blood treated with EDTA | | | | | | | | | | | | | | |
| Certification | Certified by the NGSP as traceable to the Diabetes Control and Complications Trial
(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
B (1 each), Calibrator/Diluent Set (1 each), CD-ROM (1 each), Cartridge Set (1 each),
Sample vials – package of 100 (2 each), Wash/Diluent Solution (1 each). | | | | | | | | | | | | | | |
| Chemistry | Cation Exchange Matrix | | | | | | | | | | | | | | |
| Safety Standards for
Electrical Equipment
for IVD Use | BS EN 61010 Certified | | | | | | | | | | | | | | |
| Electromagnetic
Compatibility | BS EN 61326 Certified | | | | | | | | | | | | | | |
| 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. | | | | | | | | | | | | | | |
| 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
(IFCC), or %HbA1c (JDS) | | | | | | | | | | | | | |
| Printing Options | Export text file to external printer | External printer and Export to PDF options | | | | | | | | | | | | | |
| VARIANT II TURBO
Link Testing System
Firmware | EPROM
VCS 41.507
VSS 51.505
VSS PUMP
4.50 | EPROM &n FLASH N/A HST FLASH
VCS 42.507
VSS 52.815
VSS Pump
5.0 XN 9000 FLASH
VTCS 42.507
VTSS 52.815
VTSS PUMP
5.00 Automated Sampling
Station Sysmex HST Trackline Sysmex HST or Sysmex XN-9000
Trackline Historical Database
Review N/A Archive Viewer – this tool does not allow
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)