(28 days)
Not Found
No
The description focuses on automated HPLC analysis and data management software, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic (IVD) device used for laboratory testing of blood samples to determine hemoglobin A1c and A2/F levels, which are analytical measurements for diagnosis and monitoring, not a direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "in vitro diagnostic use," and describes its use in monitoring long-term glucose control for diabetes and screening for ß-thalassemia, which are diagnostic purposes.
No
The device description clearly states that the VARIANT II Hemoglobin Testing System is a fully automated, high-throughput hemoglobin analyzer consisting of two hardware modules (VCS and VSS) in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Nature of the Test: The device performs tests on human whole blood samples to measure specific components (hemoglobin A1c, hemoglobins A2 and F, and abnormal hemoglobins). This is a classic example of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide information about a person's health.
- Intended Purpose: The tests are intended for monitoring long-term glucose control in individuals with diabetes mellitus and for screening for ß-thalassemia. These are diagnostic purposes.
- Professional Use Only: The device is intended for "Professional Use Only," which is typical for IVD devices used in clinical laboratories.
N/A
Intended Use / Indications for Use
Intended Use: VARIANT™ II Hemoglobin A1c Program
The Bio-Rad VARIANT™ II Hemoglobin A 1 c Program is intended for the percent determination of hemoglobin A 1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II Hemoglobin A 1 c 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-term glucose 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 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.
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).
Product codes (comma separated list FDA assigned to the subject device)
LCP, JPD
Device Description
The VARIANT II Hemoglobin Testing System is a fully automated, high-throughput 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™.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human whole blood
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)
Not Found
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
APR 2 5 2013 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 | | | | |
| Device Names | 1) VARIANT™ II Hemoglobin A1c Program, Catalog No.: 270-2101NU
2) 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) | | | | |
| Predicate
Devices | Table 1: Predicate Devices | | | | |
| | Device Name | 510(k)
Number | Product Regulation and
Code | | |
| | VARIANT II Hemoglobin Alc Program | K070452 | 21 CFR 864.7470 (LCP) | | |
| | VARIANT II ß-thalassemia Short Program | K063643 | 21 CFR 864.7400 (JPD) | | |
| Intended and
Indications 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-term
glucose 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 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- | | | | |
| | | | | | |
| Bio-Rad Laboratories, Inc., | | | | | |
| | VARIANT™ II Hemoglobin Alc Program / VARIANT II B-thalassemia Short Program
Special 510(k) - Device Modification | | | | |
·
I-E-6
. . .
1
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 PC | |
| Board | 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
2
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 II
Assay | Assay Part
No. | Component Names and Part Nos. | Explanation of Test |
|-----------------------------------------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VARIANT II
Hemoglobin Alc
Program | 270-2101NU | The assay contains the following
components -
• 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 II
Hemoglobin Alc Program is
a well established method of
measuring the level of
Hemoglobin Alc 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. |
| VARIANT II β-
thalassemia Short
Program | 270-2103
270-2154 | The assay contains the following
components -
• 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 is
a well established method of
measuring Hemoglobins A2
and F in human red blood
cells. A frequently occurring
thalassemia, beta-thalassemia
(β-thalassemia) is commonly
found in the heterozygous
state as β-thalassemia minor
or 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
1-E-8
3
| Table 4: VARIANT II Hemoglobin A1c Program | |||
|---|---|---|---|
| Feature | Predicate: | ||
| VARIANT II Hemoglobin A1c | |||
| Program, 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 for | |||
| Electrical Equipment | |||
| for IVD Use | BS EN 61010 Certified | ||
| Electromagnetic | |||
| Compatibility | BS EN 61326 Certified | ||
| Intended/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 high- | |||
| performance liquid chromatography (HPLC). | |||
| For in vitro diagnostic use. | |||
| Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose | |||
| control 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 Testing | |||
| System Firmware | VCS 41.300 | ||
| VSS 51.381 | |||
| VSS PUMP 4.50 | VCS 41.301 | ||
| VSS 51.403 | |||
| VSS PUMP 4.50 | VCS 42.300 | ||
| VSS 52.403 | |||
| VSS PUMP 5.00 | |||
| Historical Database | |||
| Review | N/A | Archive Viewer - this tool does not allow | |
| transmission to an LIS, and is not intended | |||
| for repeat reporting. |
Bio-Rad Laboratories, Inc., VARIANT™ II Hemoglobin AIc Program / VARIANT II ß-thalassemia Short Program Special 510(k) – Device Modification · :
.
.
4
Table 5: VARIANT II ß-thalassemia Short Program
| Feature | Predicate:
VARIANT II β-thalassemia Short
Program, K063643 | Modified device:
VARIANT II β-thalassemia Short
Program |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| 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), Whole
Blood Primer (3 / 3 packs), Sample Vials - package of 100 (1 / 1 each), Wash/Diluent
Solution (1 / 2 each), CD-ROM (1 / 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 VARIANT™ II β-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 β-thalassemia Short Program is intended for use only with
the 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 Testing
System Firmware | EPROM
VCS 41.300
VSS 51.381
VSS PUMP 4.50 | FLASH
VCS 42.300
VSS 52.403
VSS PUMP 5.00 |
| Historical Database
Review | N/A | Archive Viewer—this tool does not
allow transmission to an LIS, and is not
intended 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
1-E-10
5
- . 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 ·
1-E-11
6
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.
7
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
8
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
9
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