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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Dimension Vista® HbA1c Kit are implicitly established through its substantial equivalence claim to the predicate device and comparison with a reference method. The primary studies focus on method comparison.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Device (Dimension Vista® HA1C kit - K062128)	Method Comparison (Dimension Vista® HbA1c kit vs. Dimension Vista® HA1C kit):124 fresh, EDTA-treated whole blood samples (HbA1c range 3.8 – 16.0 %HbA1c by predicate).Passing-Bablok regression analysis:- %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)
Agreement with a recognized reference method (Tosoh Ion Exchange HPLC analyzer)	Method Comparison (Dimension Vista® HbA1c kit vs. Tosoh Ion Exchange HPLC analyzer):91 human whole blood samples preserved with EDTA (HbA1c range 4.6 to 9.6 %HbA1c).Bland-Altman bias analysis:- Mean Bias: -0.04 %HbA1c- SD: 0.26 %HbA1c- Upper 95% CI: 0.47 %HbA1c- Lower 95% CI: -0.56 %HbA1c- Tosoh Limits: ±0.75 %HbA1c (indicating the device falls well within acceptable variation from the reference)
Consistency in Intended Use, Sample Type, Technology, Sample Size, Reagents, Calibrator, and Instrument	The document explicitly states the new device has "the same technological characteristics as the Dimension Vista® HA1C kit."- Intended Use: Both for quantitative measurement of HbA1c in human anticoagulated whole blood on Dimension Vista® systems.- Sample Type: Both use human anticoagulated whole blood treated with EDTA.- Technology: Both use turbidometric inhibition immunoassay (TINIA) for HbA1c and modified alkaline hematin reaction for total hemoglobin.- Sample Size: Both use 1 uL.- Reagents: Both use similar reagents.- Calibrator: Both are lyophilized human whole blood hemolysates.- Instrument: Both used with all Dimension Vista® Systems.
Traceability of Calibrator	Calibrator traceable to NGSP and IFCC (an improvement over the predicate which was only NGSP).

Here's the additional information requested, based on the provided text:

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set 1 (vs. Predicate Device):
- Sample Size: 124 fresh, EDTA-treated whole blood samples.
- Data Provenance: Not explicitly stated, but "fresh, EDTA-treated whole blood samples" usually implies prospective collection from a clinical setting, likely within the country of the manufacturer's operation or study site. However, specific country of origin is not mentioned.
Test Set 2 (vs. Tosoh HPLC):
- Sample Size: 91 human whole blood samples preserved with EDTA.
- Data Provenance: Not explicitly stated, but similar to Test Set 1, likely prospective collection. Specific country of origin is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the test set was established by analytical methods (the predicate device and the Tosoh HPLC analyzer), not by human experts. Therefore, this question is not applicable in this context. The "experts" would be the manufacturers and certified laboratories maintaining the reference methods.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as the ground truth was established by analytical instruments. This is not applicable to an analytical device comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for image-based diagnostic systems where human readers interpret medical images. This document describes an in vitro diagnostic assay for quantitative laboratory measurements.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the studies described are of the standalone performance of the Dimension Vista® HbA1c kit. The device performs the measurement quantitatively without direct human intervention in the result generation beyond sample loading and instrument operation. The reported performance metrics (Passing-Bablok regression, Bland-Altman bias) represent the algorithm's (or device's) direct analytical output compared to reference methods.

7. The Type of Ground Truth Used

The ground truth was established by comparison with established analytical methods:
- The legally marketed predicate device (Dimension Vista® HA1C kit) for the first comparison.
- A recognized reference method, the Tosoh Ion Exchange HPLC analyzer, for the second comparison. This HPLC method is a standard for HbA1c measurement and is often considered a higher-level reference.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its size. For an in vitro diagnostic device like this, the development process would involve internal optimization and validation, but a defined "training set" in the context of machine learning (where this term is most common) is not typically described in 510(k) summaries for such devices. The method comparison studies serve as clinical validation.

9. How the Ground Truth for the Training Set Was Established

As a defined "training set" is not explicitly discussed, the method for establishing its ground truth is not provided. The development and calibration of such assays typically rely on certified reference materials and established laboratory protocols.

Summary

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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
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1. 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:

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.

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Feature	Predicate Device:Dimension Vista® HA1Ckit (K062128)	New Device:Dimension Vista® HbA1c kit
Similarities
Intended Use	Both kits are for in vitro diagnostic use for the quantitativemeasurement of hemoglobin A1c in human anticoagulated wholeblood on the Dimension Vista® systems.	Both kits are for in vitro diagnostic use for the quantitativemeasurement of hemoglobin A1c in human anticoagulated wholeblood on the Dimension Vista® systems.
Sample Type	Both devices are for use with human anticoagulated whole bloodtreated with EDTA.	Both devices are for use with human anticoagulated whole bloodtreated with EDTA.
Technology	Both devices use turbidometric inhibition immunoassay (TINIA) forthe HbA1c measurement and both devices use a modification of thealkaline hematin reaction for the total hemoglobin portion of theassay.	Both devices use turbidometric inhibition immunoassay (TINIA) forthe HbA1c measurement and both devices use a modification of thealkaline hematin reaction for the total hemoglobin portion of theassay.
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 bloodhemolysates.	Both calibrator products are lyophilized human whole bloodhemolysates.
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 andmmol/mol.
AnalyticalMeasuring Range	1.0 - 30.0 g/dL Hb0.2 - 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] Hb0.3 - 2.6 g/dL [0.2 - 1.6 mmol/L] HbA1c
Calibrator levels	Uses four calibrator levelsplus saline.	Uses five calibrator levels.
CalibratorTraceability	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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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

Regulation Number and Section

§ 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).