The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). Thev are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

The Alliance Blood Glucose 3 levels Control Solution are for use with the A-CHECK DS-A Blood Glucose Monitoring System and DS-A Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Description

Based on an electrochemical biosensor technology and the principle of capillary action, DS-A Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and is displayed in 6 seconds.

The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of blood glucose in fingertip capillary whole blood. When the blood is applied to the edge of reaction zone, the blood is drawn into the reaction chamber and will display a reading on the meter. Only a small amount of blood is needed. The test strip for the quantitative measurement of blood glucose in the range is from 20-600 mg/dL (1.1-33.3 mmol/L).

AI/ML Overview

This document describes the DS-A Blood Glucose Monitoring System and its adherence to acceptance criteria, supported by various studies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood glucose monitoring systems typically involve accuracy compared to a laboratory reference method. The document presents results based on "lay user" (home user) and "professional" (clinical setting) studies, comparing the device to the YSI 2300 STAT Plus 1M glucose analyzer.

Acceptance Criteria (Commonly accepted for Blood Glucose Monitors):

For Glucose Concentration < 75 mg/dL (4.2 mmol/L):
- ≥95% of results within ±15 mg/dL of the reference method.
For Glucose Concentration ≥ 75 mg/dL (4.2 mmol/L):
- ≥95% of results within ±15% of the reference method.

Reported Device Performance (from the provided studies):

A. For Home Users (Lay User Study):

Glucose Concentration	Acceptance Criteria (≥95% within range)	Reported Device Performance	Meets Criteria?
< 75 mg/dL	Within ± 15 mg/dL	18/18 (100%)	Yes
	Within ± 10 mg/dL	18/18 (100%)	Yes
	Within ± 5 mg/dL	15/18 (83.3%)	No
≥ 75 mg/dL	Within ± 15%	131/132 (99.2%)	Yes
	Within ± 10%	129/132 (98%)	Yes
	Within ± 5%	83/132 (62.9%)	No

B. For Professionals (Accuracy Study):

Glucose Concentration	Acceptance Criteria (≥95% within range)	Reported Device Performance	Meets Criteria?
< 75 mg/dL	Within ± 15 mg/dL	32/32 (100%)	Yes
	Within ± 10 mg/dL	25/32 (78.1%)	No
	Within ± 5 mg/dL	16/32 (50.0%)	No
≥ 75 mg/dL	Within ± 15%	136/146 (93.2%)	No (slightly below)
	Within ± 10%	124/146 (84.9%)	No
	Within ± 5%	102/146 (69.9%)	No
Note: The "For Professionals" study shows the device did not meet the ≥95% within ±15% acceptance criteria for glucose concentrations ≥ 75 mg/dL. This might indicate a discrepancy or less stringent criteria were applied for approval.

Precision (Repeatability) Study Results:

Glucose Concentrations (mg/dL)	AVG (mg/dL)	S.D. (mg/dL)	C.V.%
40	42	2.5	5.9%
80	88	4.8	4.4%
120	133	7.5	4.0%
200	211	5.1	2.3%
300	329	8.8	2.5%

2. Sample Size and Data Provenance

Test Set for Lay User Study: 150 patients.
Test Set for Professional Accuracy Study: 178 patients.
Test Set for Precision Study: 40 tests per glucose concentration level (40, 80, 120, 200, 300 mg/dL), using oxygenated Heparin-venous blood.
Data Provenance: The document does not explicitly state the country of origin for the patient data for the lay user and professional accuracy studies, but the manufacturer is from Taiwan, ROC. The studies appear to be prospective clinical studies where human blood samples were tested.

3. Number of Experts and their Qualifications for Ground Truth

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth. However, the reference method used for comparison is the YSI 2300 STAT Plus 1M glucose analyzer, which is a widely accepted laboratory reference instrument for measuring blood glucose. This implies that the 'ground truth' is established by a highly accurate laboratory method, overseen by laboratory professionals, rather than by human expert consensus (e.g., radiologists, pathologists).

4. Adjudication Method for the Test Set

Not applicable. The ground truth is established by a reference laboratory instrument (YSI 2300), not by human interpretation or consensus that would require an adjudication method.

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

Not performed. This study focuses on the standalone performance of a medical device (blood glucose monitor) compared to a reference standard, not on the comparative effectiveness of human readers with or without AI assistance. Therefore, there is no effect size reported for human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. The device, the DS-A Blood Glucose Monitoring System, was tested on its own to measure blood glucose levels, and its readings were directly compared to the YSI 2300 reference analyzer. The "Lay User" and "Accuracy" sections provide these standalone performance metrics.

7. Type of Ground Truth Used

The ground truth used was laboratory reference method data, specifically readings from the YSI 2300 STAT Plus 1M glucose analyzer. This instrument is an established device for highly accurate glucose measurement in a controlled laboratory setting.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This type of device (blood glucose monitor) likely does not involve machine learning algorithms that require a distinct training phase with labeled data in the same way an AI diagnostic tool would. The studies described are validation studies for the finished product.

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

As there is no explicit training set mentioned for an AI/ML algorithm, this question is not directly applicable. If developmental testing was done, the ground truth would have similarly been established against a highly accurate laboratory reference method (like the YSI 2300) during the design and development phases of the device.

Summary

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510(K) Summary of Safety and Effectiveness II. (Per 21 CFR 807.92)

2.1. General Information Establishment

	Date Prepared:	September 28, 2008
	Manufacturer:	ALLIANCE International Co., Ltd.
	Address:	No.54, Ying Tao Rd. Yinge Town, Taipei County, 23942, Taiwan, ROC
	Owner Number:	9099902
	Contact Person:	Dr. Jen, Ke-Min	E-mail: ceirs.jen@msa.hint.net
		886-3-5208829 (Tel); 886-3-5209783 (Fax)
	Address:	No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC
Device

● Proprietary Name:	DS-A Blood Glucose Monitoring System
● Common Name:	Blood Glucose Monitoring System
● Classification Name:	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER, Class II
● Product Code:	NBW

2.2. Safety and Effectiveness Information

. Predicate Device: Claim of Substantial Equivalence (SE) is made to ACCU-CHEK Aviva System (K043474).
Based on an electrochemical biosensor technology ● Device Description: and the principle of capillary action, DS-A Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds.

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Intended Use: .

The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. They are not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Substantial Equivalence (SE) ●

A claim of substantial equivalence is made to ACCU-CHEK Aviva System Both of them have the same working principle and (K043474). The differences are coding method, sample volume, meter technologies. dimension, weight, HCT range, and memory data number. Besides, the subject device is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger but the predicate device can test whole blood include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf. Thus the differences are due to the feature design aspects, not relating to the safety or effectiveness aspects. They are substantially equivalent.

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	Differences
Items	A-CHECK DS-A(Alliance International )Subject Device (K082965)	Accu-Chek Aviva (Roche)Predicate Device (K043474)
Test Principle	GOD Electrochemical biosensor withcarbon electrodes	GDH Electrochemical
Meter Weight	56 g	60 g
Memory Storage	360 test results	500 blood glucose results
Meter Coding	Code Card	Code Key
OperatingTemperature	14 to 40 °C	6 to 44 °C
Strip StorageTemperature	4 to 32 °C	2 to 32 °C
Limitations	A-Check Draw-In test strips aredesigned for use with fresh capillarywhole blood sample. Do Not useserum or plasma samples.1. It should not be used in IntensiveCare settings or if the patient isdehydrated, hypotensive, hypoxic,in diabetic ketoacidosis, in shock, orin a hyperglycemic/hyperosmolarstate.2. Hematocrit: Variation in samplehematocrit between 30% and 55%has no significant effect on testresults. Very high (above 55%) andvery low (below 30%) hematocritcan cause inaccurate results.3. Neonates: Do not use Draw-In teststrips to test neonates. Theperformance of this system has notbeen validated with neonatalsamples.4. Blood concentration of AscorbicAcid > 1.2mg/dL or Uric Acid >7mg/dL will cause overestimation ofblood glucose results.5. Therapeutic levels of L-dopa(>10mg/dL) or Dopamine (>30mg/dL) may result in inaccurate(elevated) glucose readings with thesystem.6. Acetaminophen (<20mg/dL),Ibuprofen (<40mg/dL).Tetracycline (< 0.4mg/dL),Tolbutamide (<100mg/dL),Cholesterol (<500mg/dL), andCreatinine (<30mg/dL) may not	1. The injection or infusion of solutioncontaining galactose or maltose(present in some humanimmunoglobulin preparations) maycause overestimation of bloodglucose results.2. Blood concentrations galactose>10mg/dL or maltose > 13 mg/dL willcause overestimation of bloodglucose results.3. Do not use during a xyloseabsorption test.4. Lipemic samples in excess of 4800mg/dL may produce elevated results.5. In situations of decreased peripheralblood flow, fingerstick blood testingmay not be appropriate as it may notreflect the true physiological state.Examples would include, but are notlimited to: severe dehydration causedby diabetic ketoacidosis or thehyperglycemic hyperosmolarnonketotic state, hypotension, shocksevere congestive heart failure, orperipheral vascular disease.6. Blood glucose determination withvenous blood must be performedwithin 30 minutes of amplecollection.7. For best results with venous blood,the followinganticoagulants/preservation isrecommended: heparin or EDTA.Serum separator tubes are acceptableif whole blood is used immediately,lodoacetate or fluoride-containinganticoagulants are not recommended.8. Refrigerated samples should be

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. Synopsis of Test Methods and Results

Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA.

For Home Users

The table below was based on a study done with 150 patients to see how well the A-Check DS-A Blood Glucose Monitoring System compared to the YSI 2300.

Image /page/3/Figure/4 description: This image is a scatter plot titled "Lay User". The x-axis is labeled "YSI 2300" and ranges from 0 to 450. The y-axis is labeled "DS-A Meter" and ranges from 0 to 450. The data points are clustered around a diagonal line, indicating a positive correlation between the two variables.

Results for glucose concentration < 75mg/dL (4.2 mmol/L)

Within ± 5mg/dL	Within ± 10mg/dL	Within ± 15mg/dL
15/18 (83.3%)	18/18 (100%)	18/18 (100%)

Results for glucose concentration ≥ 75mg/dL (4.2 mmol/L)

Within ±5%	Within ±10 %	Within ±15 %	Within ±20 %
83/132	129/132	131/132	132/132
(62.9%)	(98%)	(99.2%)	(100%)

	A-CHECK DS-A Meter vs. YSI analyzer
n	Slope	Intercept	R2
150	0.954	0.3382	0.996

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Precision (Repeatability Precision)

To compare the precision of Draw-In series test strips and the YSI 2300 STAT Plus 1M glucose analyzer, oxygenated Heparin-venous blood, properly reconstituted with exogenous glucose to a final concentration of 40, 80, 120, 200, and 300 mg/dL. 40 tests of Draw-In series test strips were performed with each glucose concentration. The results obtained were as follows:

GlucoseConcentrations(mg/dL)	40	80	120	200	300
Number of Tests	40	40	40	40	40
AVG (mg/dL)	42	88	133	211	329
S.D. (mg/dL)	2.5	4.8	7.5	5.1	8.8
C.V.%	5.9%	4.4%	4.0%	2.3%	2.5%

Linearity

A-CHECK DS-A Blood Glucose Meter comparison with YSI 2300. 2 lots of Draw-In test strips were tested to assess the accuracy of the A-CHECK DS-A Blood Glucose Monitoring System by comparing to the reference method (YSI 2300) using venous whole blood concentrations between 20 and 600 mg/dL. The linear regression correlations are as follows:

Lot	Slope	Intercept	r	R2
1	1.02	-2.1 mg/dL	0.996	0.993
2	1.01	2.5 mg/dL	0.997	0.994

Y= A-CHECK DS-A Blood Glucose Meter X= YSI 2300

Accuracy

Accuracy (A-CHECK DS-A Blood Glucose Meter) comparison with YSI: 1 lot of Draw-In test strips were tested to assess the accuracy of the A-CHECK DS-A Blood Glucose Monitoring System by comparing to the reference method (YSI 2300) using whole blood concentrations. The table below was based on a study done with 178 patients getting samples by professionals to see how well the A-Check DS-A Blood Glucose Monitoring System compared to the YSI 2300. The accuracy regression correlations are as follows:

Image /page/4/Figure/9 description: The image shows a scatter plot comparing YS12300 and A-CHECK DS-A measurements in whole blood. The plot includes a linear regression line with the equation y = 1.0032x + 4.5469 and an R-squared value of 0.9938. The plot also shows dashed lines representing a 20% deviation from the line of identity (X=Y). The sample size is n=178, with 0 values out of range and a CV% of 2.97.

YSI2300 VS. A-CHECK DS-A (Whole Blood)

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A-CHECK DS-A System accuracy results for glucose concentration < 4.2 mmol/L < < 75mg/dL >

Within ± 5 mg/dL	Within ± 10 mg/dL	Within ± 15 mg/dL
16/32 (50.0%)	25/32 (78.1%)	32/32 (100%)

A-CHECK DS-A System accuracy results for glucose concentration≥ 4.2 mmol/L < ≥75mg/dL >

Within ± 5%	Within ± 10%	Within ± 15%	Within ± 20%
102/146 (69.9%)	124/146 (84.9%)	136/146 (93.2%)	146/146 (100.0%)

Lot	Slope	Intercept	r	R2
1	1.00	4.5mg/dL	0.997	0.993

Y= A-CHECK DS-A Blood Glucose Meter X= YSI 2300

Keiichi Ito

Dr. Jen, Ke-Min official correspondent for ALLIANCE International Co., Ltd.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Alliance International Co., Ltd. c/o Dr. Ke-Min Jen No. 58, Fu Chiun Street Hsin Chu City, 30067, Taiwan, ROC

DEC - 7 2009

Re: K082965

Trade/Device Name: DS-A Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: CGA, NBW, JJX Dated: November 20, 2009 Received: December 01, 2009

Dear Dr. Jen:

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. 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): (k)082965

Device Name: DS-A Blood Glucose Monitoring System

Indication For Use:

Prescription Use (21 CFR Part 801 Subpart D) And / Or

Over the Counter Use _ V (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 (OIVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) (k)082965

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.