(208 days)
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No
The summary describes a standard in vitro diagnostic assay for measuring HbA1c using chemical reagents and an analyzer system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies are standard method comparisons, not evaluations of AI/ML model performance.
No
This device is an in vitro diagnostic assay used for measuring HbA1c, which aids in monitoring long-term glucose control for individuals with diabetes. It does not directly treat or alleviate a disease, but rather provides diagnostic information.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic assay" used for the "quantitative determination of per cent Hemoglobin A1c in human anticoagulated whole blood" to monitor long-term glucose control in individuals with diabetes mellitus.
No
The device description clearly states it includes physical components like reagent cartridges and calibrator, which are not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "quantitative determination of per cent Hemoglobin A1c in human anticoagulated whole blood." This is a test performed on a biological sample (whole blood) outside of the body to provide information about a person's health status (monitoring long term glucose control in individuals with diabetes mellitus).
- Device Description: The description details reagents and calibrators used to perform the test on a laboratory instrument (Dimension Vista® system). These components are designed to be used in vitro (in glass, or in this case, in a laboratory setting) to analyze the blood sample.
- Performance Studies: The performance studies describe testing conducted on human whole blood samples to evaluate the accuracy and reliability of the assay. This is typical for IVD devices.
The definition of an In Vitro Diagnostic (IVD) device is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures. This device clearly fits this definition.
N/A
Intended Use / Indications for Use
The HbA1c assay used on the Dimension Vista® system is an in vitro diagnostic assay for the quantitative determination of per cent Hemoglobin A1c in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
HbA 1c calibrator is intended for use in the calibration of the Hemoglobin A 1c (HbA 1c) method on the Dimension Vista® system.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JIT
Device Description
The Dimension Vista® HbA1c kit contains Flex® reagent cartridges and calibrator. Each cartridge contains reagents used to measure total hemoglobin and hemoglobin A1c. the reagents are liquid and ready to use on the instrument. The calibrator in the kit is a five level lyophilized product. Each level is hydrated with 2.0mL of reagent grade water. The lot matched reagents and calibrator product are for use on the Dimension Vista Systems.
Mentions image processing
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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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
A split sample method comparison was conducted using the new device, Dimension Vista ® HbA1c kit vs. the predicate, Dimension Vista®HA1C kit. one hundred and twenty- four (124) fresh, EDTA-treated whole blood samples with HbA1c values ranging 3.8 – 16.0 %HbA1c by the Dimension Vista®HA1C kit. The data was analyzed using Passing-Bablok regression analysis.
Results:
%HbA1c:
Intercept: 0.71 (95% CI: 0.43 to 0.96)
Slope: 0.93 (95% CI: 0.89 to 0.97)
mmol/mol HbA1c:
Intercept: 6.13 (95% CI: 3.95 to 7.83)
Slope: 0.93 (95% CI: 0.89 to 0.97)
N = 124
A split sample method comparison was also performed with the new device, Dimension Vista ® HbA1c kit and the Tosoh Ion Exchange HPLC analyzer using ninety- one (91) human whole blood samples preserved with EDTA. The HbA1c values from 4.6 to 9.6% HbA1c were used in a Bland-Altman bias analysis.
Results:
Mean Bias = - 0.04 %HbA1c
SD = 0.26 %HbA1c
Upper 95% Cl =0.47 %HbA1c
Lower 95% CI = -0.56%HbA1c
Tosoh Limits = ± 0.75 %HbA1c
Range of Values 4.6 - 9.6 %HbA1c
n = 91
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.
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.
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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).
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§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
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FEB 1 4 2011
510(k) Summary for Dimension Vista® HbA1c Kit
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: | K102045 |
|---|---|
| -------------------------------- | --------- |
-
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Siemens Healthcare Diagnostics Inc |
|---|---|
| Newark, Delaware 19714-6101 |
Contact Information: Siemens Healthcare Diagnostics Inc. 500 GBC Drive P.O. Box 6101 Newark, Delaware 19714-6101 Attn: A. Kathleen Ennis Tel: 302-631-9352 Fax: 302-631-6299
Preparation date: November 9, 2010
2. Device Name:
Dimension Vista® HbA1c Kit Classification: Class II Product Code: LCP Panel: Hematology
3. Identification of the Legally Marketed Device:
Dimension Vista® HA1C Kit - K062128
4. Device Descriptions:
The Dimension Vista® HbA1c kit contains Flex® reagent cartridges and calibrator. Each cartridge contains reagents used to measure total hemoglobin and hemoglobin A1c. the reagents are liquid and ready to use on the instrument. The calibrator in the kit is a five level lyophilized product. Each level is hydrated with 2.0mL of reagent grade water. The
- lot matched reagents and calibrator product are for use on the Dimension Vista Systems.
ട. Device Intended Uses:
The HbA1c assay on the Dimension Vista System is an in vitro diagnostic assay for the quantitative determination of hemoclobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
Summary of the devices technological characteristics રં.
The Dimension Vista® HbA1c kit has the same technological characteristics as the Dimension Vista® HA1C kit. A comparison of features is provided.
1
| Feature | Predicate Device:
Dimension Vista® HA1C
kit (K062128) | New Device:
Dimension Vista® HbA1c kit |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Both kits are for in vitro diagnostic use for the quantitative
measurement of hemoglobin A1c in human anticoagulated whole
blood on the Dimension Vista® systems. | Both kits are for in vitro diagnostic use for the quantitative
measurement of hemoglobin A1c in human anticoagulated whole
blood on the Dimension Vista® systems. |
| Sample Type | Both devices are for use with human anticoagulated whole blood
treated with EDTA. | Both devices are for use with human anticoagulated whole blood
treated with EDTA. |
| Technology | Both devices use turbidometric inhibition immunoassay (TINIA) for
the HbA1c measurement and both devices use a modification of the
alkaline hematin reaction for the total hemoglobin portion of the
assay. | Both devices use turbidometric inhibition immunoassay (TINIA) for
the HbA1c measurement and both devices use a modification of the
alkaline hematin reaction for the total hemoglobin portion of the
assay. |
| Sample size | Both assays use 1 uL from the sample cup. | Both assays use 1 uL from the sample cup. |
| Reagents | The methods use similar reagents. | The methods use similar reagents. |
| Calibrator | Both calibrator products are lyophilized human whole blood
hemolysates. | Both calibrator products are lyophilized human whole blood
hemolysates. |
| Instrument | Both methods are used with all models of the Dimension Vista®
Systems. | Both methods are used with all models of the Dimension Vista®
Systems. |
| Differences | | |
| Reporting Units | Reports in %HbA1c. | Reports in both %HbA1c and
mmol/mol. |
| Analytical
Measuring Range | 1.0 - 30.0 g/dL Hb
0.2 - 2.9 g/dL HbA1c | 3.5 - 16.0 % [ 15 - 151 mmol/mol]
5.0 - 25.0 g/dL [3.1 - 15.5 mmol/L] Hb
0.3 - 2.6 g/dL [0.2 - 1.6 mmol/L] HbA1c |
| Calibrator levels | Uses four calibrator levels
plus saline. | Uses five calibrator levels. |
| Calibrator
Traceability | Traceable to NGSP | Traceable to NGSP and IFCC |
7. Method Comparison
A split sample method comparison was conducted using the new device, Dimension Vista ® HbA1c kit vs. the predicate, Dimension Vista®HA1C kit. one hundred and twenty- four (124) fresh, EDTA-treated whole blood samples with HbA1c values ranging 3.8 – 16.0 %HbA1c by the Dimension Vista®HA1C kit . The data was analyzed using Passing-Bablok regression analysis. The analysis is as follows:
| %HbA1c | mmol/mol HbA1c | |||
|---|---|---|---|---|
| Coefficient | 95% CI | Coefficient | 95% CI | |
| Intercept | 0.71 | 0.43 to 0.96 | 6.13 | 3.95 to 7.83 |
| Slope | 0.93 | 0.89 to 0.97 | 0.93 | 0.89 to 0.97 |
| N = 124 |
CONFIDENTIAL
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A split sample method comparison was also performed with the new device, Dimension Vista ® HbA1c kit and the Tosoh Ion Exchange HPLC analyzer using ninety- one (91) human whole blood samples preserved with EDTA. The HbA1c values from 4.6 to 9.6% HbA1c were used in a Bland-Altman bias analysis. The analysis is as follows:
Mean Bias = - 0.04 %HbA1c SD = 0.26 %HbA1c Upper 95% Cl =0.47 %HbA1c Lower 95% CI = -0.56%HbA1c Tosoh Limits = ± 0.75 %HbA1c Range of Values 4.6 - 9.6 %HbA1c n = 91
8. Conclusion
Based on a review of the devices technological features and the method comparison study, the new Dimension Vista® HbA1c kit is substantially equivalent to the legally marketed device, Dimension Vista® HA1C kit.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines resembling a bird or a wing-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics Inc. c/o Ms. Anna-Marie K. Ennis Regulatory Affairs Manager 500 GBC Drive, M/S 514 Newark, DE 19714-6101
Re: K102045
Trade/Device Name: Dimension VISTA HbAlc Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay. Regulatory Class: Class II Product Code: LCP, JIT Dated: January 14, 2011 Received: January 18, 2011
IED 1 & Chi
Dear Ms. Ennis
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 class II (Special Controls), 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 (reporting of medical device-related 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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Page 2 -
lf you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro 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 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 tollyfre mo (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. 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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Indication for: Use
510(k) Number (if known): K102045
Device Name: Dimension Vista HbAlc
Indication For Use:
The HbAlc assay used on the Dimension Vista® system is an in vitro diagnostic assay for the quantitative determination of per cent Hemoglobin A1c in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
HbA 1c calibrator is intended for use in the calibration of the Hemoglobin A 1c (HbA 1c) method on the Dimension Vista® system.
Prescription Use x (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
( and
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
1.0(k) K102045