The HB1C assay on the Dimension® clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.

The HB1C CAL is an in vitro diagnostic product for the calibration of the Hemoglobin A1c (HB1C) method on the Dimension® clinical chemistry system.

Device Description

The Dimension® HB1C kit contains Flex® reagent cartridges and calibrator. Each cartridge contains reagents used to measure total hemoglobin and hemoglobin A1 . 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 all models of the Dimension® clinical chemistry system.

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of predefined thresholds for statistical metrics (e.g., "slope must be between X and Y", "intercept must be between A and B"). Instead, the study aims to demonstrate "substantial equivalence" to a legally marketed predicate device (BIO-RAD Variant® II Hemoglobin A1c) through a method comparison. The reported device performance is presented as the results of this comparison.

Metric (from Deming Regression)	Acceptance Criteria (Implicit from Substantial Equivalence Goal)	Reported Device Performance (Dimension® HB1C vs. BIO-RAD Variant® II)
%HbA1c Analysis	Demonstrate substantial equivalence to predicate device.
Intercept	(No explicit numerical criteria stated, but expected to be close to 0)	0.44 (95% CI: 0.12 - 0.75)
Slope	(No explicit numerical criteria stated, but expected to be close to 1)	0.90 (95% CI: 0.85 - 0.94)
mmol/mol Analysis	Demonstrate substantial equivalence to predicate device.
Intercept	(No explicit numerical criteria stated, but expected to be close to 0)	2.17 (95% CI: -0.35 - 4.70)
Slope	(No explicit numerical criteria stated, but expected to be close to 1)	0.90 (95% CI: 0.85 - 0.95)

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

Sample Size:
- For %HbA1c analysis: 124 human whole blood samples.
- For mmol/mol analysis: 123 human whole blood samples.
- Note: The document states "One hundred and twenty- six (126) human whole blood samples... ranging from 4.4 to 16.18 homo". It then indicates that 2 samples were excluded from the %HbA1c analysis and 3 from the mmol/mol analysis because they were "out of range by one or both of the methods".
Data Provenance: Human anticoagulated whole blood samples preserved with EDTA. The country of origin is not specified, and it is presented as a retrospective analysis of collected samples.

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

Not applicable. This study is a method comparison against a predicate device, not a diagnostic accuracy study establishing ground truth through expert review.

4. Adjudication Method for the Test Set

Not applicable. No adjudication by experts was performed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a comparison of two in vitro diagnostic (IVD) assays, not an AI-assisted diagnostic device involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The study directly compares the results of the new device (Dimension® HB1C kit) with the predicate device (BIO-RAD Variant® II Hemoglobin A1c) without human intervention in the interpretation of the raw assay results. It’s a standalone device performance comparison for quantitative measurements.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurements obtained from the legally marketed predicate device, BIO-RAD Variant® II Hemoglobin A1c. The study aims to demonstrate that the new device produces results substantially equivalent to this established method. Both methods are certified by the NGSP as traceable to the Diabetes Control and Complications Trial (DCCT) and traceable to the IFCC reference method.

8. The Sample Size for the Training Set

Not applicable. This is an analytical method comparison study, not a machine learning model training.

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

Not applicable. No training set or machine learning model is involved.

Summary

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Siemens Healthcare Diagnostics Inc. Dimension® HB1C method and calibrator 510(k) Notification

MAY 13 2011

510(k) Summary for

Dimension® HB1C 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: Ki02510

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:

Manufacturer:	Siemens Healthcare Diagnostics IncNewark, Delaware 19714-6101
Contact Information:	Siemens Healthcare Diagnostics Inc.500 GBC DriveP.O. Box 6101Newark, Delaware 19714-6101Attn: A. Kathleen EnnisTel: 302-631-9352Fax: 302-631-6299
Preparation date:	August 24, 2010
Device Name:	Dimension® HB1C Kit containing HB1C Flex® reagent cartridges and HB1C Calibrator

Classification: Class II

Product Code: LCP/KRZ

Panel: Hematology

3. ldentification of the Legally Marketed Device:

BIO-RAD Variant® II Hemoglobin A16 - K070452

4. Device Descriptions:

ર્ . Device Intended Uses:

CONFIDENTIAL

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6. Summary of the devices technological characteristics

The Dimension ® HB1C kit has the same characteristics as the BIO-RAD Variant® II Hemoglobin Are. A comparison of features is provided.

Feature	Predicate Device:	New Device:
	BIO-RAD Variant® II HbA₁c	Dimension® HB1C kit
	K070452
Similarities
Intended Use	Both kits are for in vitro diagnostic use for the quantitative determination of hemoglobin A1c in human whole blood.	Both kits are for in vitro diagnostic use for the quantitative determination of hemoglobin A1c in human whole blood.
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.
Calibrator	Both devices are calibrated with whole blood hemolysate provided in lyophilized form.	Both devices are calibrated with whole blood hemolysate provided in lyophilized form.
Certification	Both methods certified by the NGSP as traceable to the Diabetes Control and Complications Trial (DCCT).	Both methods certified by the NGSP as traceable to the Diabetes Control and Complications Trial (DCCT).
Traceability	Both methods are traceable to the IFCC reference method.	Both methods are traceable to the IFCC reference method.
Sample Preparation	Both methods sample directly and dilute on board.	Both methods sample directly and dilute on board.
Packaging	Both kits contain the reagents and calibrator.	Both kits contain the reagents and calibrator.
Differences
Instrument	BIO-RAD Variant® II HPLC	All models of the Dimension® clinical chemistry system
Reporting Units	Reports in %HbA1c.	Reports in both %HbA1c and mmol/mol.
Analytical MeasuringRange	3.1 – 18.5 % HbA1c	3.6 – 16.0 % [17 – 151 mmol/mol]
Calibrator levels	Provides two calibrator levels plus a diluent for preparation of additional levels.	Includes five calibrator levels.
Technology	Uses ion-exchange high-performance liquid chromatography (HPLC).	Uses 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

7. Method Comparison

A split sample method comparison was conducted using the new device, Dimension ® HB1C kit vs. the predicate, BIO-RAD Variant® II Hemoglobin Ay. One hundred and twenty- six (126) human whole blood samples preserved with EDTA ranging from 4.4 to 16.18 homo and the month whole blood analyzed using Deming regression analysis. The analysis is as follows:

	%HbA1c		mmol/mol
	Coefficient	95% CI		Coefficient	95% CI
Intercept	0.44	0.12	0.75	2.17	-0.35	4.70
Slope	0.90	0.85	0.94	0.90	0.85	0.95
n	1241			1232

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Siemens Healthcare Diagnostics Inc.
Dimension® HB1C method and calibrator 510(k) Notification

¹ Two samples, out of range by one or both of the methods, were not included in the analysis

² Three samples, out of range by one or both of the methods, were not included in the analysis

8. Conclusion

Based on a review of the devices technological features and the method comparison study, the new Dimension® HB1C kit is substantially equivalent to the legally marketed device, BIO-RAD Varian® II Hemoglobin A1c.

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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 features the department's name in a circular arrangement around the perimeter. In the center is a stylized symbol resembling a caduceus or a bird-like figure, representing health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics Inc.
c/o Ms. Anna Marie Ennis
500 GBC Drive
PO Box 6101
Newark, DE 19714

MAY 1 3 2011

Re: K102510

Trade/Device Name: Dimension® HB1C kit (Model DF 105A), Dimension® HB1C Calibrator Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP & JJX Dated: April 5, 2011 Received: April 7, 2011

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). 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

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 tolli fire (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

: 172 :

Enclosure

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Indications for Use Form

510(k) Number (if known): K 102510

Dimension(r)HB1C Kit

Device Name:

Indications for Use:

The HB1C assay on the Dimension® clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin Alc (HbAlc) in human anticoagulated whole blood. Measurements of hemoglobin Alc are effective in monitoring long term glucose control in individuals with diabetes mellitus.

XX Prescription Use Over-The-Counter Use Prescription Ose _____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102510

Page 1 of

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Indications for Use Form

510(k) Number (if known): K102510

Dimension(r)HB1C Calibrator

Device Name:

Indications for Use:

The HB1C CAL is an in vitro diagnostic product for the calibration of the Hemoglobin A1c (HB1C) method on the Dimension® clinical chemistry system.

XX Prescription Use Over-The-Counter Use Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (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 Diagnostic Devices (OIVD)

Cawf C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102510

Page 2 of 2

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).