(28 days)
The Bio-Rad VARIANT™ II Hemoglobin A Ic Program is intended for the percent determination of hemoglobin A Ic in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II Hemoglobin Alc Program is intended for Professional Use Only. For in vitro diagnostic use. Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
The VARIANT™ II ß-thalassemia Short Program is intended for the separation and area percent determinations of hemoglobins A2 and F, and as an aid in the identification of abnormal hemoglobins in whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II ß-thalassemia Short Program is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use. Measurement of the percent hemoglobin A2 and F are effective in screening of ß-thalassemia (i.e., hereditary hemolytic anemias characterized by decreased synthesis or more types of abnormal hemoglobin polypeptide chains).
The VARIANT II Hemoglobin Testing System is a fully automated, highthroughput hemoglobin analyzer. The VARIANT II Hemoglobin Testing System provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobin in whole blood. It consists of two modules - the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT System using Clinical Data Management (CDM) Software.
A personal computer (PC) is used to control the VARIANT II Hemoglobin Testing 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™.
This K130860 submission is a Special 510(k) for a device modification, meaning the changes are to existing predicate devices (VARIANT II Hemoglobin A1c Program and VARIANT II ß-thalassemia Short Program) and aim to demonstrate substantial equivalence without impacting the core performance specifications, intended use, or operating principles. The modifications primarily involve software and firmware updates, along with a PC Board replacement.
Therefore, the study focuses on verification and validation (V&V) testing to ensure the modified device remains safe, effective, and substantially equivalent to its predicate. It does not present new performance data against specific acceptance criteria for diagnostic accuracy as would be expected for a novel device or a device with significant performance changes. Instead, it asserts that the changes do not affect the previously established performance claims.
Here's an analysis based on the provided text, focusing on how the device meets acceptance criteria related to its modifications:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a device modification submission where the performance specifications are stated to be unchanged from the predicate, the acceptance criteria are implicitly that the modified device's performance is at least as good as the predicate device and that the modifications do not introduce new risks or degrade existing performance. The "performance" reported is the outcome of the verification/validation and risk management processes.
| Acceptance Criteria (Implicit for Device Modification) | Reported Device Performance (as stated in the submission) |
|---|---|
| No change to performance specifications | "When compared to the predicate device, there are no changes to the performance specifications, intended or indications for use, or operating principles.""No change or impact, claims transferred from predicate device." (for both programs) |
| No adverse impact on product safety and effectiveness | "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.""deemed the modified product safe, effective, and comparable to the predicate device." |
| Modifications developed under design controls | "In addition, these changes were designed, developed and implemented under established design control and GMP processes..." |
| Compliance with risk management for modifications | "In accordance with ISO 14971, 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.""The risk evaluation for the device software and firmware modifications included the following tasks..." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for a "test set" in the traditional sense of a clinical or analytical performance study. Given the nature of a Special 510(k) for software/firmware/hardware changes, the "test set" would refer to the data and scenarios used during verification and validation (V&V) testing.
- Sample Size: Not explicitly stated as a number of patient samples. The V&V efforts would likely involve testing various functionalities, defect fixes using specific test cases, and potentially a range of instrument data (already available or specifically generated for V&V).
- Data Provenance: Not explicitly stated. For "defect corrections," the data likely originated from "customer feedback" and scenarios that caused the identified defects. For general V&V, it would involve internal testing data. It's implied to be retrospective, as it addresses "customer feedback" and "defects" from prior versions, but specific details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable or not provided for this submission. The ground truth in this context is typically related to diagnostic accuracy, which is not being re-evaluated because performance claims are "transferred from predicate device."
For defect fixes, the "ground truth" would be whether the defect is successfully resolved and the intended functionality works as designed. This is assessed by engineering and quality assurance teams during V&V. The document mentions "a trained risk assessment team" for FMEA, but not "experts" establishing a diagnostic ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable/not provided. No "adjudication method" for interpreting results from a test set is mentioned because the submission directly states that performance specifications and claims are unchanged and transferred from the predicate. The "ground truth" for V&V testing of software/firmware changes is based on successful execution of tests and resolution of identified bugs, not on expert consensus interpretation of diagnostic output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an automated in vitro diagnostic (HPLC system) for measuring specific hemoglobin levels, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The device itself (VARIANT II Hemoglobin Testing System with CDM Software) operates as a standalone automated system for measurement. The changes are to its software/firmware. The V&V testing would assess the functionality of this automated system in its modified state. So, the testing effectively evaluates the "standalone" performance of the modified system, but it's not a new standalone study; it's a re-validation of the existing standalone system after modifications. The performance claims are asserted to be the same as the predicate (which was a standalone device).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the original predicate devices, the ground truth for establishing performance (e.g., accuracy of HbA1c or HbA2/F measurements) would have been based on comparison to reference methods or clinical outcomes.
For this specific submission (device modification):
- For defect corrections: The "ground truth" is the successful elimination of the defect and the proper functioning of the software features (e.g., CDM not crashing, calibrator reassignment working). This is validated through internal software testing.
- For performance: The submission directly states "No change or impact, claims transferred from predicate device." This means the ground truth for performance measures (precision, accuracy, linearity, etc.) was established during the original predicate device's clearance and is implicitly inherited rather than re-established in detail for this modification. The V&V here confirmed that the modifications did not degrade the ability to achieve those previously established performance characteristics.
8. The Sample Size for the Training Set
Not applicable/not provided. This device is not described as involving a machine learning algorithm that requires a "training set." The software and firmware updates are for controlling the HPLC system and managing data, not for learning from data in the way an AI algorithm would.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no training set for a machine learning algorithm is involved, this question is not relevant to the submission.
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APR 2 5 2013 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 | ||||
| Device Names | 1) VARIANT™ II Hemoglobin A1c Program, Catalog No.: 270-2101NU2) VARIANT™ II ß-thalassemia Short Program, Catalog Nos .: 270-2103,270-2154 | ||||
| Classification | 1) Glycosylated hemoglobin assay, 21 CFR 864.7470 (LCP)2) Hemoglobin A2 assay, 21 CFR 864.7400 (JPD) | ||||
| PredicateDevices | Table 1: Predicate Devices | ||||
| Device Name | 510(k)Number | Product Regulation andCode | |||
| VARIANT II Hemoglobin Alc Program | K070452 | 21 CFR 864.7470 (LCP) | |||
| VARIANT II ß-thalassemia Short Program | K063643 | 21 CFR 864.7400 (JPD) | |||
| Intended andIndications for | Intended Use: VARIANT II Hemoglobin A1c Program | ||||
| Use | The Bio-Rad VARIANT™ II Hemoglobin A Ic Program is intended for the | ||||
| percent determination of hemoglobin A Ic in human whole blood using ion- | |||||
| exchange high-performance liquid chromatography (HPLC). The Bio-Rad | |||||
| VARIANT II Hemoglobin Alc Program is intended for Professional Use Only.For in vitro diagnostic use. | |||||
| Indications for Use: VARIANT II Hemoglobin A1c Program | |||||
| Measurement of percent hemoglobin A1c is effective in monitoring long-termglucose control in individuals with diabetes mellitus. | |||||
| Intended Use: VARIANT II ß-thalassemia Short Program | |||||
| The VARIANT™ II ß-thalassemia Short Program is intended for the separationand area percent determinations of hemoglobins A2 and F, and as an aid in theidentification of abnormal hemoglobins in whole blood using ion-exchange high- | |||||
| Bio-Rad Laboratories, Inc., | |||||
| VARIANT™ II Hemoglobin Alc Program / VARIANT II B-thalassemia Short ProgramSpecial 510(k) - Device Modification |
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performance liquid chromatography (HPLC). The Bio-Rad VARIANT II ßthalassemia Short Program is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use.
Indications for Use: VARIANT II B-thalassemia Short Program
Measurement of the percent hemoglobin A2 and F are effective in screening of ß-thalassemia (i.e., hereditary hemolytic anemias characterized by decreased synthesis or more types of abnormal hemoglobin polypeptide chains).
Submission Purpose
Submission Purpose and History
The software updates include customer requested features, whereas both software and firmware include specific defect fixes. When compared to the predicate device, there 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.
Notification of previous changes
Utilizing the Risk Management Process, FDA guidance documents and regulations it was determined that the following changes did not warrant a premarket submission:
Table 2: Notification of Previous Modifications
| Modification | Description of Modification |
|---|---|
| CDM 4.02 –5.1.1 | As a result of a field corrective action, Golden Rules was implemented to serve as a preventative tool that detects sampling identification errors and prevents the transmission of errant results to an LIS (v.4.02/4.03) Added conversion factor between IFCC, JDS, and NGSP that aligned with the existing labeling, international customer and regulatory requirements—Europe and Japan. (v.5.1) Added Export to PDF and automated priming function to improve ease-of-use and analysis workflows (v.5.1) Two defect corrections, identified with the Reanalysis feature, were implemented to address customer feedback—1) defect #1 caused CDM to crash when in the Reanalysis Window and 2) defect #2 did not allow calibrator reassignment in Reanalysis because of an unpopulated calibration table (v.5.1.1) |
| Updated PCBoard | Replaced obsolescent PC Board (implemented with CDM v.5.1.1 concurrently) |
In addition, these changes were designed, developed and implemented under established design control and GMP processes; there were no changes to the intended/indications for use, performance specifications, or operating principles.
Bio-Rad Laboratories, Inc., VARIANT™ II Hemoglobin Alc Program / VARIANT II ß-thalassemia Short Program Special 510(k) - Device Modification
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Moreover, documentation to support these changes and processes are stored in the applicable Design History Files; therefore, this Special 510(k) covers the recent firmware and software changes only, as described in the Submission Purpose section.
Description of Instrument
The VARIANT II Hemoglobin Testing System is a fully automated, highthroughput hemoglobin analyzer. The VARIANT II Hemoglobin Testing System provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobin in whole blood. It consists of two modules - the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT System using Clinical Data Management (CDM) Software.
A personal computer (PC) is used to control the VARIANT II Hemoglobin Testing 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 IIAssay | Assay PartNo. | Component Names and Part Nos. | Explanation of Test |
|---|---|---|---|
| VARIANT IIHemoglobin AlcProgram | 270-2101NU | The assay contains the followingcomponents -• Whole Blood Primer, 270-0350• Elution Buffer A, 270-2110NU• Elution Buffer B, 270-2111NU• Wash/Diluent Solution, 270-2112NU• Analytical Cartridge, 270-2113NU• CD-ROM, 270-2114NU• Calibrator/Diluent Set, 270-2115NU• Sample Vials, 270-2149 | The VARIANT IIHemoglobin Alc Program isa well established method ofmeasuring the level ofHemoglobin Alc in red bloodcells. Therapy for diabetesrequires the long-termmaintenance of a bloodglucose level as close aspossible to normal levels tominimize the risk of long-term vascular consequences. |
| VARIANT II β-thalassemia ShortProgram | 270-2103270-2154 | The assay contains the followingcomponents -• Elution Buffer 1, 270-0004• Elution Buffer 2, 270-0005• HbA2/F Calibrator/Diluent Set,270-0083• Analytical Cartridge, 270-0182• Whole Blood Primer, 270-0351• Sample Vials, 270-2149• Wash/Diluent Solution, 270-2164• CD-ROM, 270-2165 | The VARIANT II β-thalassemia Short Program isa well established method ofmeasuring Hemoglobins A2and F in human red bloodcells. A frequently occurringthalassemia, beta-thalassemia(β-thalassemia) is commonlyfound in the heterozygousstate as β-thalassemia minoror β-thalassemia trait. |
Table 3: FDA-cleared assays for use on the VARIANT II Hemoglobin Testing System with CDM Software
Comparison to The following tables delineate the similarities and differences between the Predicate predicates and modified devices. Device
Bio-Rad Laboratories, Inc., VARIANT™ II Hemoglobin Alc Program / VARIANT II ß-thalassemia Short Program Special 510(k) - Device Modification
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| Table 4: VARIANT II Hemoglobin A1c Program | |||
|---|---|---|---|
| Feature | Predicate:VARIANT II Hemoglobin A1cProgram, K070452 | Modified device:VARIANT II Hemoglobin A1c Program | |
| Similarities | |||
| Technology | Ion-exchange high performance liquid chromatography | ||
| Sample type | Anticoagulated whole blood (EDTA) | ||
| 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. | ||
| Certification | Certified by the IFCC as traceable to the IFCC Reference Measurement Procedure. | ||
| Instrument Control | Windows Operating System with Proprietary Assay Software | ||
| Kit configuration | Whole Blood Primer (2 each), Elution Buffer A (3 each), Elution Buffer B (1 each),Wash/Diluent Solution (3 each), Analytical Cartridge (1 each), CD-ROM (1 each),Calibrator/Diluent Set (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 | ||
| Intended/Indicationsfor Use | The Bio-Rad VARIANT II Hemoglobin A1c Program is intended for the percentdetermination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).For in vitro diagnostic use. | ||
| Measurement of percent hemoglobin A1c is effective in monitoring long-term glucosecontrol in individuals with diabetes mellitus. | |||
| Performance Claims | No change or impact, claims transferred from predicate device. | ||
| Differences | |||
| CDM Software | CDM Software version 4.0 | CDM Software version 5.2 | |
| EPROM | EPROM | FLASH | |
| VARIANT II TestingSystem Firmware | VCS 41.300VSS 51.381VSS PUMP 4.50 | VCS 41.301VSS 51.403VSS PUMP 4.50 | VCS 42.300VSS 52.403VSS PUMP 5.00 |
| Historical DatabaseReview | N/A | Archive Viewer - this tool does not allowtransmission to an LIS, and is not intendedfor repeat reporting. |
Bio-Rad Laboratories, Inc., VARIANT™ II Hemoglobin AIc Program / VARIANT II ß-thalassemia Short Program Special 510(k) – Device Modification · :
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Table 5: VARIANT II ß-thalassemia Short Program
| Feature | Predicate:VARIANT II β-thalassemia ShortProgram, K063643 | Modified device:VARIANT II β-thalassemia ShortProgram |
|---|---|---|
| Similarities | ||
| Technology | Ion-exchange high performance liquid chromatography | |
| Sample type | Anticoagulated whole blood (EDTA) | |
| Calibrator | Human anticoagulated whole blood treated with EDTA | |
| Instrument Control | Windows Operating System with Proprietary Assay Software | |
| Kit configuration | 250 Tests / 500 Tests: Elution Buffer 1 (2 / 3 each), Elution Buffer 2 (1 / 2 each),HbA2/F Calibrator/Diluent Set (1 / 1 set), Analytical Cartridge (1 / 2 each), WholeBlood Primer (3 / 3 packs), Sample Vials - package of 100 (1 / 1 each), Wash/DiluentSolution (1 / 2 each), CD-ROM (1 / 1 each) | |
| Chemistry | Cation Exchange Matrix | |
| Safety Standards forElectrical Equipmentfor IVD Use | BS EN 61010 Certified | |
| ElectromagneticCompatibility | BS EN 61326 Certified | |
| Intended Use | The VARIANT™ II β-thalassemia Short Program is intended for the separation andarea percent determinations of hemoglobins A2 and F, and as an aid in theidentification of abnormal hemoglobins in whole blood using ion-exchange high-performance liquid chromatography (HPLC).The Bio-Rad VARIANT II β-thalassemia Short Program is intended for use only withthe Bio-Rad VARIANT II Hemoglobin Testing System. | |
| Performance Claims | For in vitro diagnostic use.No change or impact, claims transferred from predicate device. | |
| Differences | ||
| CDM Software | CDM Software version 4.0 | CDM Software version 5.2 |
| VARIANT II TestingSystem Firmware | EPROMVCS 41.300VSS 51.381VSS PUMP 4.50 | FLASHVCS 42.300VSS 52.403VSS 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, 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;
Bio-Rad Laboratories, Inc.,
VARIANT™ II Hemoglobin A1c Program / VARIANT II ß-thalassemia Short Program Special 510(k) - Device Modification
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- . Reviewed existing product risk tables and customer complaints to identify potential risks and hazards:
- . Considered requirements of IEC 62304, 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, the general features and characteristics of the assay, and the use of the same technology, it can be concluded that the VARIANT II Hemoglobin Alc Program and VARIANT II Bthalassemia Short Program are substantially equivalent to the cleared and currently marketed predicate devices.
Bio-Rad Laboratories, Inc., VARIANT™ II Hemoglobin Alc Program / VARIANT II ß-thalassemia Short Program Special 510(k) - Device Modification 1-E-11 ·
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 fashion around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Bio-Rad Laboratories, Inc. C/O Ebony McKinnies 4000 Alfred Nobel Drive HERCULES CA 94545
April 25, 2013
Re: K130860
Trade/Device-Name:-VARIANTIM-II-Hemoglobin-A1c-Program VARIANTTM II TM B-thalassemia Short Program Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JPD Dated: March 21, 2013 Received: March 28, 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/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.
Denise Johnson-lyles -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): K130860
Device Name: VARIANT™ II Hemoglobin A1c Program /VARIANT™ II B-thalassemia Short Program
Indications for Use. ---------------------------------------------------------------------------------------------------------------------------------------------------------
The Bio-Rad VARIANT™ II Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange highperformance liquid chromatography (HPLC). The Bio-Rad VARIANT II Hemoglobin A 1 c Program is intended for Professional Use Only. For in vitro diagnostic use. " """""
Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
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)
Katherine /Serrano
Division Sign-Off Office of In Vitro Diagnostics and Radiologic Health
510(k) K130860
Page 1 of 2
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Indications for Use Form
510(k) Number (if known): K130860
Device Name: VARIANT™ II Hemoglobin A1c Program /VARIANT™ II B-thalassemia Short Program
Indications for Use:
The VARIANT™ II B-thalassemia Short Program is intended for the separation and area percent determinations of hemoglobins A2 and F, and as an aid in the identification of abnormal hemoglobins in whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II B-thalassemia Short Program is intended for use only with the Bio-Rad VARIANT II Hemoglobin Testing System. For in vitro diagnostic use.
Measurement of the percent hemoglobin A2 and F are effective in screening of Bthalassemia (i.e., hereditary hemolytic anemias characterized by decreased synthesis or more types of abnormal hemoglobin polypeptide chains)
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Kathering Serrano
Division Sign-Off Office of In Vitro Diagnostics and Radiologic Health
510(k) K130860
Page 2 of 2
§ 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).