(29 days)
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.
The VARIANT II TURBO Hemoglobin Testing System is the next generation HPLC system with higher volume capability when compared to the VARIANT II 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™.
The provided text describes a Special 510(k) Summary for a Device Modification related to the Bio-Rad VARIANT™ II TURBO HbA1c Kit - 2.0. This type of submission is for modifications to a legally marketed device that do not significantly alter its performance specifications, intended use, or operating principles.
Crucially, the document explicitly states:
- "When compared to the predicate device, there are no changes to the performance specifications, intended or indications for use, or operating principles."
- "Performance Claims: No change, claims transferred from predicate device."
Therefore, this specific submission does not present new acceptance criteria or a new study to prove device performance, as the performance claims are directly transferred from the predicate device (K122472). The modifications described are primarily software and firmware updates, customer-requested features, and defect fixes.
The document focuses on demonstrating that these changes do not affect product safety, effectiveness, and substantial equivalency claims to the predicate device. This is achieved through a risk management process, review of modifications, and design verification/validation tests.
Based on the provided text, I cannot extract the specific acceptance criteria and a study proving those criteria were met for this modified device because the submission relies on the established performance of its predicate.
However, I can describe what the document does provide in relation to an implicit "acceptance" or validation of the modifications:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of new acceptance criteria for performance, nor new reported device performance data, because the performance claims are stated to be unchanged from the predicate device.
Instead, the "acceptance criteria" for the modifications themselves relate to successful verification and validation (V&V) testing.
| Acceptance Criteria (for modifications) | Reported Device Performance (for modifications) |
|---|---|
| "Determined whether risk mitigations, hazard controls, and residual risks were as safe and effective as the predicate device." | "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.""The modified product [is] safe, effective, and comparable to the predicate device." |
| "Modified product [is] safe, effective, and comparable to the predicate device." (Derived from risk management report conclusion) | (See above) |
| No changes to performance specifications, intended use, indications for use, or operating principles (criteria implicitly met for substantial equivalence) | "When compared to the predicate device, there are no changes to the performance specifications, intended or indications for use, or operating principles." |
2. Sample Size Used for the Test Set and Data Provenance
The document details "design verification/validation tests" and a risk management process, but does not specify sample sizes for these tests. It also does not explicitly mention the country of origin or whether the data was retrospective or prospective, as the focus is on the software and firmware changes and their impact on safety and effectiveness, rather than a clinical performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states: "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."
- Number of Experts: Not explicitly stated, but implies a "team" (more than one).
- Qualifications of Experts: Described as a "trained risk assessment team." No further specific qualifications (e.g., radiologist with X years of experience) are provided, which is typical for device engineering and risk management teams.
4. Adjudication Method for the Test Set
The FMEA process involved a "trained risk assessment team until consensus was reached," suggesting a form of group adjudication, but no specific method like "2+1" or "3+1" is detailed. It implies a collaborative decision-making process to reach agreement on risk identification and mitigation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of results, where the AI might assist or replace that interpretation. This device is an automated in vitro diagnostic system for measuring HbA1c, and its modifications are software/firmware related, not involving human interpretation of clinical images or data in a way that would necessitate an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The device itself is an automated system. The "design verification/validation tests" would have evaluated the performance of the modified software and firmware in a standalone manner, integrated into the instrument, to ensure it met its functional and safety requirements. However, the document doesn't provide details on the specific "standalone" tests conducted beyond stating they "met established acceptance criteria" for the modifications.
7. The Type of Ground Truth Used
For the modifications, the "ground truth" was established based on:
- Identified potential risks and hazards (from reviewing modifications, design inputs, existing risk tables, customer complaints, and IEC 62304:2009 requirements).
- Predicate device claims and performance established during its initial clearance (K122472), against which the modified device's safety, effectiveness, and substantial equivalency were assessed.
For the predicate device's original performance claims (which are transferred), the ground truth for HbA1c measurement is based on:
- Certification by the NGSP as traceable to the Diabetes Control and Complications Trial (DCCT) Reference method.
- Certification by the IFCC as traceable to the IFCC Reference Measurement Procedure.
8. The Sample Size for the Training Set
Not applicable. This submission is for modifications to an existing in vitro diagnostic device, not a new algorithm that requires a "training set" in the context of machine learning. The software and firmware updates "include customer requested features, whereas both software and firmware include specific defect fixes," implying development rather than a machine learning training process.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a machine learning "training set" in this context.
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Special 510(k) Summary – Device Modification
| Introduction | This 510(k) summary is being submitted in accordance with the requirements of21 CFR 807.92 and the Safe Medical Device Act of 1990. | ||||
|---|---|---|---|---|---|
| Submitter | Bio-Rad Laboratories, Inc.Clinical Systems Division4000 Alfred Nobel DriveHercules, CA 94545 | ||||
| ContactPerson | Ebony McKinniesRegulatory Affairs Representative | ||||
| DateSubmitted | 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)Number | Product Regulation andCode | ||
| VARIANT™ II TURBO HbAlc Kit - 2.0 | K122472 | 21 CFR 864.7470 [LCP] | |||
| Intended andIndicationsfor Use | The Bio-Rad VARIANT™ II TURBO HbA Ic Kit - 2.0 is intended for thequantitative determination of hemoglobin Alc in human whole blood using ion-exchange high performance liquid chromatography (HPLC) on the VARIANT IITURBO Hemoglobin Testing System. Measurement of hemoglobin Alc iseffective in monitoring long term glycemic control in individuals with diabetesmellitus. The Bio-Rad VARIANT II TURBO HbAlc Kit - 2.0 is intended forprofessional Use. | ||||
| Description ofChange | The software updates include customer requested features, whereas both softwareand firmware include specific defect fixes. When compared to the predicatedevice, there are no changes to the performance specifications, intended orindications for use, or operating principles. Moreover, Risk Analysis andVerification/Validation testing results demonstrate that the changes do not affectproduct 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 IITURBO Assay | Assay PartNo. | Component Names and Part Nos. | Explanation of Test |
|---|---|---|---|
| VARIANT IITURBOHbA1c Kit –2.0 | 270-2455 | The assay contains the followingcomponents – Whole Blood Primer, 270-0350,270-0351, 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/Availablecomponents: Wash/Diluent Solution Set, 270-2730 Cartridge Holder Installation Kit,270-2463 Prefilters, 270-2464 Stainless Steel Prefilter Adapters,270-2465 Microvial Adapters, 270-2016-10 | The VARIANT IITURBO HbA1c Kit– 2.0 is a wellestablished method ofmeasuring the levelof Hemoglobin A1cin red blood cells.Therapy for diabetesrequires the long-term maintenance ofa blood glucose levelas close as possible tonormal levels tominimize the risk oflong-term vascularconsequences. |
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:Bio-Rad VARIANT™ II TURBOHbA1c Kit -2.0, 510(k) 122472 | Modified device:Bio-Rad VARIANT™ II TURBO HbA1cKit -2.0 |
|---|---|---|
| Similarities | ||
| Technology | Ion-exchange high performance liquid chromatography | |
| Sample type | Anticoagulated whole blood (EDTA) | |
| Calibrator | Human anticoagulated whole blood treated with EDTA | |
| Calibrationfrequency | Once every 500 injections/ 2500 injections total column life | |
| Certification | Certified by the NGSP as traceable to the Diabetes Control and ComplicationsTrial (DCCT) Reference method. | |
| Certification | Certified by the IFCC as traceable to the IFCC Reference MeasurementProcedure. | |
| Instrument Control | Windows Operating System with Proprietary Assay Software | |
| Kit configuration | 2500 Tests: Whole Blood Primer (2 each), Elution Buffer A (5 each),Elution B (1 each), Calibrator/Diluent Set (1 each), CD-ROM (1 each),Analytical Cartridge (1 each), Sample Vials – package of 100 (1 each). | |
| Chemistry | Cation Exchange Matrix | |
| Safety Standards forElectrical Equipmentfor IVD Use | BS EN 61010 Certified | |
| ElectromagneticCompatibility | 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 bloodusing ion-exchange HPLC on the VARIANT II TURBO Hemoglobin TestingSystem. Measurement of percent HbA1c is effective in monitoring long-termglucose 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 IITURBO TestingSystem Firmware | VCS 41.507VSS 51.505VSS PUMP 4.50 | VCS 42.507VSS 52.523VSS PUMP 5.00 |
| Historical DatabaseReview | N/A | Archive Viewer - this tool does notallow transmission to an LIS, and is notintended 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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black against a white background. The overall design is simple and recognizable, representing the department's focus on health and human services.
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 (800) 638-2041 or (301) 796-7100 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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§ 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).