(132 days)
(k)070452
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No
The summary describes a standard HPLC-based laboratory test for HbA1c and does not mention any AI or ML components.
No.
This device is for the percent determination of hemoglobin A1c, which is used for monitoring long-term glucose control, not for treating a condition.
Yes
The device is intended for the percent determination of hemoglobin A1c in human whole blood, which is used to monitor long-term glucose control in individuals with diabetes mellitus. This measurement provides information used to diagnose and manage a medical condition, thus classifying it as a diagnostic device.
No
The device description explicitly states it uses the principles of high performance liquid chromatography (HPLC) and is based on chromatographic separation on a cation exchange cartridge, indicating it is a hardware-based system with a kit.
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 indicates the device is used to test a biological sample (human whole blood) in vitro (outside the body) to provide diagnostic information (monitoring long-term glucose control in individuals with diabetes mellitus).
- Device Description: The description details a system that uses principles of high performance liquid chromatography (HPLC) and a cation exchange cartridge to separate and measure components of the blood sample. This is a typical method used in laboratory settings for in vitro analysis.
- Professional Use Only: The indication for "Professional Use Only" further supports its use in a clinical or laboratory setting for diagnostic purposes.
The information provided aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Bio-Rad VARIANT II TURBO HbA1c Kit - 2.0 is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
The Bio-Rad VARIANT II TURBO HbA1c Kit - 2.0 is intended for Professional Use Only.
Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Product codes (comma separated list FDA assigned to the subject device)
LCP
Device Description
The VARIANT II TURBO Hemoglobin-Testing System uses the principles of high performance liquid chromatography (HPLC). The VARIANT II TURBO HbA1c kit -2.0 is based on chromatographic separation of Hemoglobin A1c on a cation exchange cartridge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Professional Use Only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Accuracy:
Method correlation between the VARIANT II TURBO HbA1c Kit - 2.0 (270-2455) and VARIANT II Hemoglobin A1c Program (270-2101NU) was compared using 40 EDTA whole blood patient samples and 12 samples prepared by mixing EDTA whole blood patient samples with Lyphochek® Hemoglobin A1c Linearity Set samples in various ratios. The range of values on the VARIANT II TURBO HbA1c Kit -2.0 was from 2.6% to 19.0% HbA1c.
Precision:
Method precision was performed using a protocol based on the NCCLS Evaluation protocol, Vol.24, No. 25, EP5-A2 for the VARIANT II TURBO HbA1c Kit - 2.0 and the VARIANT II Hemoglobin A1c (270-2101NU). The protocols for both the VARIANT II TURBO HbA1c Kit -- 2.0 and the VARIANT II Hemoglobin A1c Programs are similar.
For the VARIANT II TURBO HbA1c Kit - 2.0 and the VARIANT II Hemoglobin A1c Program protocol, six VARIANT II TURBO and six VARIANT II Hemoglobin Testing Systems at three Bio-Rad sites were utilized. Each site was provided with the same sample set and performed two replicates of each sample on each of 2 runs per day for 10 days.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy:
Method correlation between the VARIANT II TURBO HbA1c Kit - 2.0 (270-2455) and VARIANT II Hemoglobin A1c Program (270-2101NU) was compared using 40 EDTA whole blood patient samples and 12 samples prepared by mixing EDTA whole blood patient samples with Lyphochek® Hemoglobin A1c Linearity Set samples in various ratios. The range of values on the VARIANT II TURBO HbA1c Kit -2.0 was from 2.6% to 19.0% HbA1c.
Precision:
The precision results between the VARIANT II TURBO Hemoglobin A1c (270-2255) and the current VARIANT II Hemoglobin A1c Program (270-2101NU) are equivalent.
VARIANT II TURBO HbA1c Kit - 2.0 (270-2455) Precision:
Low Patient (HbA1c): n=240, Mean=5.6, Within run (%CV)=0.78, Within Device Precision (%CV)=1.15
High Patient (HbA1c): n=240, Mean=11.4, Within run (%CV)=0.39, Within Device Precision (%CV)=0.91
VARIANT II Hemoglobin A1c (270-2101NU) Precision:
Low Patient (HbA1c): n=240, Mean=5.5, Within run (%CV)=0.9, Within Device Precision (%CV)=1.60
High Patient (HbA1c): n=160, Mean=8.8, Within run (%CV)=0.6, Within Device Precision (%CV)=1.38
Linearity:
VARIANT II TURBO HbA1c Kit – 2.0 (210-2455): Linear Range 3.5 – 19.0 % HbA1c
VARIANT II Hemoglobin A1c Program (210-2101NU): Linear Range 3.1 – 18.5 % HbA1c
Interfering Substances:
Bilirubin: No interference up to 20 mg/dL for both devices.
Lipids (Triglycerides): No interference up to 6000 mg/dL for both devices.
EDTA: No interference up to 11X EDTA for both devices.
Hemoglobin F: 25% for VARIANT II TURBO HbA1c Kit-2.0, 15% for VARIANT II Hemoglobin A1c.
Interference from HbS, HbC, HbE, HbD trait samples on %A1c:
VARIANT II TURBO HbA1c Kit-2.0: Two out of 7 hemoglobin AD-trait, 2 out of 11 hemoglobin AS-trait, 1 out of 12 hemoglobin AE-trait, and 3 out of 9 hemoglobin AC-trait patient samples at the clinically significant levels of 6% and 9% HbA1c exhibited differences of more than ±10% from values obtained using boronate affinity reference method.
VARIANT II Hemoglobin A1c: No interference.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
(k)070452
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
JUL 2,7 2009
Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:_ Trade/Device Name: VARIANT II TURBO HbA1c Kit-2.0 Regulation Number: 21 CFR § 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP Dated: June 17, 2009 Received: June 18, 2009
Dear Jackie Buckley:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of medical devicerelated adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K090699
Device Name: VARIANT II TURBO™ HbAje Kit - 2.0
Indications For Use:
The Bio-Rad VARIANT™ II TURBO HbA1c Kit -2.0 is intended for the percent determination of hemoglobin Att in human whole blood using ion-exchange highperformance liquid chromatography (HPLC). Bio-Rad VARIANT™ II TURBO HbAic kit is intended for Professional Use Only.
Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Curl Benam
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K090699