(80 days)
Not Found
No
The summary describes a device based on HPLC technology for measuring HbA1c and does not mention any AI or ML components.
No.
This device is an in-vitro diagnostic (IVD) device used for measuring hemoglobin A1c, which is a diagnostic function for monitoring diabetes, not for treating or rehabilitating a condition.
Yes
The device determines the percent of hemoglobin A1c in human whole blood, which is used for monitoring long-term glucose control in individuals with diabetes mellitus, thus providing information critical for diagnosis, monitoring, or treatment.
No
The device description explicitly states that the system uses the principles of high performance liquid chromatography (HPLC) and is based on chromatographic separation on a cation exchange cartridge, indicating the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "percent determination of hemoglobin A1c in human whole blood." This involves testing a biological sample (human whole blood) in vitro (outside the body) to obtain diagnostic information (monitoring long-term glucose control in individuals with diabetes mellitus).
- Device Description: The description details a method for analyzing a biological sample (whole blood) using a laboratory technique (HPLC) to measure a specific analyte (Hemoglobin A1c).
- Professional Use Only: The indication for "Professional Use Only" is common for IVD devices that require trained personnel to operate and interpret the results.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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).
The Bio-Rad VARIANT II Hemoglobin A1c Program 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
LCP, KRZ
Device Description
The VARIANT II Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of Hemoglobin A1c on a cation exchange cartridge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Use Only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Accuracy (Method Correlation):
Sample Size: 42 EDTA whole blood patient samples
Data Source: Patient samples ranging from 4.2% to 10.9% HbA12.
Annotation Protocol: Not explicitly stated, but implies measurement using both the new and predicate devices.
Precision (New VARIANT II Hemoglobin A1c Program protocol):
Sample Size: Not explicitly stated for initial sample set. For the summary table, n=240 for Low Patient (HbA1c) and n=160 for High Patient (HbA1c).
Data Source: Low and high EDTA whole blood patient samples.
Annotation Protocol: Based on NCCLS Evaluation protocol, Vol.24, No. 25, EP5-A2 (2004). 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/day for 10 days.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy:
Study Type: Method Correlation
Sample Size: 42 EDTA whole blood patient samples
Key Results: Results are presented in a regression table (table content not fully visible).
Precision:
Study Type: Method Precision
Sample Size:
New VARIANT II Hemoglobin A1c Program: 240 (low patient samples), 160 (high patient samples)
Current VARIANT II Hemoglobin A1c Program: 80 (low patient samples), 80 (high patient samples)
Key Results: Precision results between the new VARIANT II Hemoglobin A1c (270-2101NU) and the current VARIANT II Hemoglobin A1c Program (270-2101) are equivalent.
Linearity:
Key Results: Linear Range for VARIANT II Hemoglobin A1c Program (210-2101NU) is 3.1 - 18.5 % HbA1c.
Interfering Substances:
Key Results: No interference from Bilirubin up to 20 mg/dL, Lipids (Triglycerides) up to 6000 mg/dL, EDTA up to 11X EDTA. Hemoglobin F shows 10% interference.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision (%CV):
New VARIANT II Hemoglobin A1c (270-2101NU):
Low Patient (HbA1c): Within run (%CV) = 0.9, Within Device Precision (%CV) = 1.60
High Patient (HbA1c): Within run (%CV) = 0.6, Within Device Precision (%CV) = 1.38
VARIANT II Hemoglobin A1c (270-2101):
Low Patient (HbA1c): Within run (%CV) = 1.46, Total Precision (%CV) = 2.14
High Patient (HbA1c): Within run (%CV) = 0.65, Total Precision (%CV) = 1.68
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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:_ 070452__
| Submitter: | Bio-Rad Laboratories, Inc.
Clinical Diagnostics Group
4000 Alfred Nobel Drive,
Hercules, California 94547
Phone: (510) 741-5309
FAX: (510) 741-6471 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jackie Buckley
Regulatory Affairs Representative |
| Date of Summary Preparation: | February 14, 2007 |
| Device Name: | VARIANT™ II Hemoglobin A1c Program
(Catalog number 270-2101NU) |
| Classification Name: | Assay, Glycosylated Hemoglobin, 81LCP |
| Predicate Device: | VARIANT™ II Hemoglobin A1c Program
K984268
Bio-Rad Laboratories, Inc.
(Catalog number 270-2101) |
| Intended 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).
The Bio-Rad VARIANT II Hemoglobin A1c
Program is intended for Professional Use Only. |
| Indications for Use: | Measurement of percent hemoglobin A1c is
effective in monitoring long-term glucose control in
individuals with diabetes mellitus. |
1
Description of the Device:
The VARIANT II Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of Hemoglobin A1c on a cation exchange cartridge.
Technical Characteristics Compared to the Predicate:
The new VARIANT II Hemoglobin A1c Program (270-2101NU) and the predicate VARIANT II Hemoglobin A1c Program (270-2101) have the same technical characteristics that are summarized in the table below:
| Characteristics | VARIANT II Hemoglobin A1c
(270-2101NU) | VARIANT II Hemoglobin A1c
(270-2101) (k)984268 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte Measured: Reported | %Hemoglobin A1c | %Hemoglobin A1c |
| Intended 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).
The Bio-Rad VARIANT II Hemoglobin A1c
Program is intended for Professional Use
Only. | 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. |
| Assay Principle | Cation exchange high performance liquid
chromatography | Cation exchange high performance liquid
chromatography |
| Sample Type | Human anticoagulated whole blood (EDTA) | Human anticoagulated whole blood (EDTA) |
| Visible Detection | 415 nm | 415 nm |
| Total Area Range | 1.5 – 4.5 million μvolt·second | 1.0 – 4.0 million μvolt·second |
| Calibration Frequency | After installation of the analytical
cartridge and once every 30 days | After installation of the analytical cartridge |
| Reconstituted Calibrator Stability | 30 days | 7 days |
| Calibrator Reconstitution Volume | 7 mL | 5 mL |
| Cartridges Included in Kit | 1 Cartridge (1000 tests) | 2 Cartridges (500 tests each) |
| Standardization | Traceable to the Diabetes Control and
Complications Trial (DCCT) reference
method and IFCC. Certified via the National
Glycohemoglobin Standardization Program
(NGSP). | Traceable to the Diabetes Control and
Complications Trial (DCCT) reference method
and IFCC. Certified via the National
Glycohemoglobin Standardization Program
(NGSP). |
2
Testing To Establish Substantial Equivalence:
Accuracy:
Method correlation between the new VARIANT II Hemoglobin A1c Program (270-2101NU) and current VARIANT II Hemoglobin A1c Program (270-2101) was evaluated using 42 EDTA whole blood patient samples ranging from 4.2% to 10.9% HbA12. The results are presented in the following regression table.
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ക്കുകയില് കേരള കൈക്കുന്നു. പ്രവേശത്തിലെ സ്ഥിതിക്കുന്നു. അവലംബം വാഹന്സ്. സംഭവന്സ്. സ്വാസസ്ത്രിക്കുന്നത്. സമ്മാനവും സ്ഥാന |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
Precision:
The following table provides comparison data on the precision between the new VARIANT II Hemoglobin A1c (270-2101NU) and VARIANT II Hemoglobin A1c (270-2101) Programs, each utilizing low and high EDTA whole blood patient samples, and both tested against samples with moderate (5.4/5.5) and high (8.8- 13.7) % A1c content.
Method precision was performed using a protocol based on the NCCLS Evaluation protocol, Vol.24, No. 25, EP5-A2 (2004) for the new VARIANT II Hemoglobin A1c (270-2101NU) and NCCLS Evaluation protocol, Vol.12, No. 4, EP5-T2 (Mar. 1992) for the current VARIANT II Hemoglobin Air Program (270-2101). The protocols for both the new VARIANT II Hemoglobin A1c and current VARIANT II Hemoglobin A1c Programs are similar.
For the new VARIANT II Hemoglobin A1c Program protocol, 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/day for 10 days.
For the current VARIANT II Hemoglobin A1c Program protocol, 40 runs (2 per day) were performed on one VARIANT II Hemoglobin Testing System over 20 working days. In each duplicate daily run, one aliquot of low HbAIc and one aliquot of high HbA1c patient samples were each analyzed per run.
Although the precision samples are different, since they were run at different time periods, the precision results between the new VARIANT II Hemoglobin A1c (270-2101NU) and the current VARIANT II Hemoglobin A1c Program (270-2101) are equivalent. A summary of combined comparative precision results is presented in the following precision table.
3
VARIANT II Hemoglobin A1c (270-2101NU) and VARIANT II Hemoglobin A1c (270-2101) Precision
| New VARIANT II Hemoglobin A1c
(270-2101NU) | | VARIANT II Hemoglobin A1c
(270-2101) | | |
|-----------------------------------------------|----------------------|-----------------------------------------|----------------------|------|
| Low Patient (HbA1c) | High Patient (HbA1c) | Low Patient (HbA1c) | High Patient (HbA1c) | |
| n= (number of samples) | 240 | 160 | 80 | 80 |
| Mean | 5.5 | 8.8 | 5.4 | 13.7 |
| Within run (%CV) | 0.9 | 0.6 | 1.46 | 0.65 |
| Within Device
Precision (%CV) | 1.60 | 1.38 | NA | NA |
| Total Precision (%CV) | NA | NA | 2.14 | 1.68 |
Linearity:
| | VARIANT II Hemoglobin A1c
Program (210-2101NU) | VARIANT II Hemoglobin A1c
Program (270-2101) |
|--------------|---------------------------------------------------|-------------------------------------------------|
| Linear Range | 3.1 - 18.5 % HbA1c | 1.3 - 18.9 % HbA1c |
Interfering Substances:
| Interfering Substance | VARIANT II Hemoglobin A1c
(270-2101NU) | VARIANT II Hemoglobin A1c
(270-2101) |
|---------------------------|-------------------------------------------|-----------------------------------------|
| Bilirubin | No interference up to 20 mg/dL | No interference up to 20 mg/dL |
| Lipids
(Triglycerides) | No interference up to 6000
mg/dL | No interference up to 6000
mg/dL |
| EDTA | No interference up to 11X EDTA | No interference up to 11X EDTA |
| Hemoglobin F | 10% | 15% |
Conclusion:
When considering the similarities of the intended use, the general characteristics of the two assays, the use of the same technology and the similar correlation, accuracy and linearity between the two methods, it can be concluded that the new VARIANT II Hemoglobin Alc Program (270-2101NU) is substantially equivalent to the cleared and currently marketed predicate, VARIANT II Hemoglobin A1c Program (270-2101).
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three bars representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bio-Rad Laboratories, Inc. c/o Ms. Jackie H. Buckley 4000 Alfred Nobel Drive Hercules, CA 94547
MAY -7 2007
Re: K070452
Trade Name: Variant II Hemoglobin A1c Program Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, KRZ Dated: February 14, 2007 Received: February 16, 2007
Dear Ms. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.v.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K070452
Device Name: VARIANT II Hemoglobin A1c 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 A1c Program is intended for Professional Use Only.
Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Sign-Off
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ිffice of In Vitro Diagnostic Device i