The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (%HbA1c) levels in fresh fingerstick capillary blood or venous whole blood samples. This system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes.

The SD A1cCare Spoit Type Test Kit is part of the SD A1cCare System. It includes the test panel that receives the blood sample and is used with the SD A1cCare Analyzer for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh fingerstick capillary or venous whole blood samples. The system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control in persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes.

The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level M are intended for use as quality control materials for the SD A1cCare System.

Device Description

The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh capillary or venous whole blood samples. It is intended for professional use.

The SD HbA1c Control Set is intended for use as quality control materials for the SD A1cCare System.

The SD A1cCare System include the analyzer, analyzer check strip, DC power adapter, immunoassay test panels, lot-specific calibration code chips, and control set.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SD A1cCare System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "All testing met acceptance criteria," but it does not provide a table with specific numerical acceptance criteria alongside the reported device performance for each test. Instead, it lists the types of tests conducted.

To provide a tabular format, I will extract the types of tests mentioned under "Functional and Safety Testing" and indicate that the results met unstated acceptance criteria.

Acceptance Criteria Category	Reported Device Performance
NGSP certification	Met acceptance criteria
Accuracy method comparison	Met acceptance criteria
Linearity	Met acceptance criteria
Precision	Met acceptance criteria
Comparison of Spoit Type test kit performance	Met acceptance criteria
Hematocrit range	Met acceptance criteria
Interferences	Met acceptance criteria
Hemoglobin variants	Met acceptance criteria
Total hemoglobin	Met acceptance criteria
Altitude	Met acceptance criteria
Testing time	Met acceptance criteria
Operating temperature range	Met acceptance criteria
Optimal sample and mixture volume	Met acceptance criteria
Anticoagulants	Met acceptance criteria
Sample collection and preparation	Met acceptance criteria
Stability of blood samples	Met acceptance criteria
Vibration	Met acceptance criteria
Temperature and humidity	Met acceptance criteria
EMC and electrical safety testing	Met acceptance criteria
Shelf-life testing	Met acceptance criteria
Software verification and validation	Met acceptance criteria

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

The document mentions "a user study clinical evaluation was conducted comparing home user results against a reference method." However, it does not specify the sample size for this test set nor the specific country of origin for the data. It implies the data is prospective, gathered from the user study.

For other functional and safety tests, no specific sample sizes are provided.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth. It states "comparing home user results against a reference method," but the nature of this reference method and the involvement of experts in its establishment or application are not detailed.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. It only mentions a comparison against a "reference method."

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device is an immunoassay system designed for quantitative measurement, not an imaging or diagnostic aid typically assessed via MRMC studies. The "user study clinical evaluation" compared home user results to a reference method, which is different from an MRMC study assessing human reader improvement with AI assistance.

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

Yes, the studies described are indicative of standalone performance of the device. The "SD A1cCare System" is an automated reflectometry immunoassay system. The bench testing and clinical evaluation would assess the performance of this system (analyzer and test kit) in isolation, measuring its accuracy, precision, linearity, etc., without an explicit human-in-the-loop component influencing the measurement itself. The "user study clinical evaluation" did involve home users, but their role was in operating the device, not in interpreting results in conjunction with an AI algorithm.

7. Type of Ground Truth Used

The ground truth for the clinical evaluation was established by a "reference method". The specific nature of this reference method is not detailed, but for HbA1c assays, it typically refers to a highly accurate laboratory method (e.g., HPLC or mass spectrometry, often NGSP-certified) used to provide the true HbA1c values against which the device's measurements are compared.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. Immunoassays like the SD A1cCare System typically use a different development and validation paradigm than machine learning models that require distinct training and test sets. While the system may have undergone internal calibration and optimization during development, the text does not refer to a "training set" in the context of a machine learning algorithm.

9. How Ground Truth for the Training Set Was Established

As no "training set" in the machine learning sense is mentioned, this information is not available in the provided text. The calibration and performance optimization of an immunoassay system would typically be based on a series of characterized samples and reference methods, but this is not referred to as a "training set."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 30, 2015

SD BIOSENSOR, INC. C/O PRISCILLA CHUNG OFFICIAL CORRESPONDENT 2651 E CHAPMAN AVE STE 110 FULLERTON CA 92831

Re: K140827

Trade/Device Name: SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JJE, JJE, JJX Dated: August 21, 2015 Received: August 28, 2015

Dear Priscilla Chung:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140827

Device Name

SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set

Indications for Use (Describe)

The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level M are intended for use as quality control materials for the SD A1cCare System.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

(K140827)

This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter:	SD Biosensor, Inc.C-4th & 5th Floor, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu,Suwon-si, Gyeonggi-do, Republic of Korea443-702
Contact Person:	Yeon, ParkQA/RA Assistant ManagerPhone: 011-82-31-300-0416FAX: 011-82-31-300-0497py@sdbiosensor.com
Date Prepared:	September 29, 2015
Trade Names:	SD A1cCareSystemSD A1cCare Spoit Type Test KitSD HbA1c Control Set
Classifications:	21 CFR 864.7470; Assay, Glycosylated Hemoglobin21 CFR 862.1660; Quality control material (assayed and unassayed)21 CFR 862.2160; Discrete photometric chemistry analyzer for clinical use
Product Codes:	LCP, JJE, JJX
Predicate Devices:	A1cNow+ (Professional Use) [K090413]; Bayer HealthCare Diabetes CareAfinion HbA1c Contols [K110056]; AXIS-SHIELD POC AS
Device Description:	The SD A1cCare System is a reflectometry immunoassay used for thequantitative measurement of glycated hemoglobin (HbA1c) levels infresh capillary or venous whole blood samples. It is intended forprofessional use.The SD HbA1c Control Set is intended for use as quality control materialsfor the SD A1cCare System.The SD A1cCare System include the analyzer, analyzer check strip, DCpower adapter, immunoassay test panels, lot-specific calibration codechips, and control set.
Intended Use:	The SD A1cCare System is a reflectometry immunoassay used for thequantitative measurement of glycated hemoglobin (%HbA1c) levels infresh fingerstick capillary blood or venous whole blood samples. Thissystem is intended for clinical laboratory and point-of-care use to monitorlong term glycemic control of persons previously diagnosed with diabetes.This test is not for screening or diagnosis of diabetes.The SD A1cCare Spoit Type Test Kit is part of the SD A1cCare System. Itincludes the test panel that receives the blood sample and is used with theSD A1cCare Analyzer for the quantitative measurement of glycatedhemoglobin (HbA1c) levels in fresh fingerstick capillary or venous wholeblood samples. The system is intended for clinical laboratory and point-of-
	care use to monitor long term glycemic control in persons previouslydiagnosed with diabetes. This test is not for screening or diagnosis ofdiabetes.The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level
	M are intended for use as quality control materials for the SD A1cCareSystem.
Comparison ofTechnologicalCharacteristics:	Like the predicate, the SD A1cCare System employs immunoassaytechnology to measure HbA1c from both capillary and venous samples.The SD A1cCare System provides quality control using a check strip,control set, and a lot-specific code chip for reagent test panels; whereas,the predicate has internal quality control checks for the analyzer, controlsolutions, and requires the user to match meter and reagent testcartridges to ensure proper calibration. Like the predicate, the SDA1cCare System requires simple preparation of the blood sample prior toapplication to the reagents. Like the predicate, the SD A1cCare Systemrequires a 5 µL blood samples and display test results on a Liquid CrystalDisplay (LCD) within a few minutes.
	For control material, the predicate and the subject device have the sameindication for use and the principle of operation. There are differences innumber of levels, package, storage condition, shelf life time, use life time;however, the results of the performance tests provided in this submissionsupport that the subject device is substantially equivalent to thepredicate device in safety and effectiveness.
Functional and SafetyTesting:	Bench testing addressed the following: NGSP certification, accuracymethod comparison, linearity, precision, comparison of Spoit Type testkit performance, hematocrit range, interferences, hemoglobin variants,total hemoglobin, altitude, testing time, operating temperature range,optimal sample and mixture volume, anticoagulants, sample collectionand preparation, stability of blood samples, vibration, temperature andhumidity. EMC and electrical safety testing was done. Shelf-life testingwas conducted on the reagent test panels and control sets. Software wassubject to design control during development and comprehensiveverification and validation testing. No animal testing was conducted. Auser study clinical evaluation was conducted comparing home userresults against a reference method which also evaluated ease-of-understanding of the instructions.
Conclusion:	The technological and functional characteristics of the SD A1cCaresystems are substantially equivalent to that of the predicate product. Alltesting met acceptance criteria and support the contention that the SDA1cCare systems are substantially equivalent to the predicate product.

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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).