The i-QARE DS-W Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The i-QARE DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The i-QARE DS-W Draw-in Blood Glucose Test Strips are for use with the i-QARE DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Description

Based on an electrochemical biosensor technology and the principle of capillary action, i-QARE DS-W 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.

AI/ML Overview

This document describes the i-QARE DS-W Blood Glucose Monitoring System. However, it does not contain a detailed study report that proves the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily providing a comprehensive study with detailed acceptance criteria and performance against those criteria.

Here's a breakdown of what can be extracted, and what cannot:

Information that can be extracted:

Device Name: i-QARE DS-W Blood Glucose Monitoring System
Predicate Device: DS-A Blood Glucose Monitoring System (K082965)
Intended Use: Quantitative measurement of glucose in fresh capillary whole blood samples from fingertips, forearm, or palm for self-testing by people with diabetes at home. Not for diagnosis, screening, or neonatal use.
Test Principle: Electrochemical biosensor with carbon electrodes.
Measuring Time: 6 seconds
Detecting Range: 20 ~ 600 mg/dL
Sample Volume: 0.7 µL
Specimen Type: Capillary whole blood from fingertip, palm, and forearm.
HCT Range: 20 ~ 60 %
Training Set Sample Size: Not explicitly stated, however, the document mentions "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." This indicates that some clinical data was used.
How ground truth for the training set was established: Not explicitly stated, beyond the general statement that "Pre-clinical and clinical data are employed". For glucose meters, ground truth is typically established using a reference laboratory method, but this is not detailed here.

Information that CANNOT be extracted from the provided text:

A table of acceptance criteria and the reported device performance: While there are limitations listed, and a general statement about "accurate results for the larger range have been validated. The results were all within ±15% acceptable range" concerning HCT, a formal table of explicit acceptance criteria and corresponding reported performance metrics (e.g., accuracy percentages, bias, precision) is not provided. The "±15% acceptable range" related to HCT seems to be the closest to an acceptance criterion mentioned, but it's not a comprehensive set.
Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "relevant clinical and performance tests" but does not provide specific sample sizes for the test set or the country of origin/retrospective/prospective nature of the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
Adjudication method for the test set: Not applicable and not mentioned, as this is typically for subjective assessments, whereas glucose measurement is objective.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable and not mentioned, as this device is a standalone measurement system, not an AI-assisted interpretation tool for human readers.
If a standalone performance (algorithm only without human-in-the-loop performance) was done: The document describes a "Blood Glucose Monitoring System" which is inherently a standalone device. While the performance of the system as a whole is discussed, the specific term "standalone algorithm-only" in the context of human-in-the-loop is not explicitly used because it's not an AI-driven image interpretation system. Its performance is its standalone performance. No separate human-in-the-loop component is described beyond the user operating the device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for a blood glucose monitor, the ground truth would typically be a laboratory reference method (e.g., YSI analyzer).

Summary of available and unavailable information based on the input text:

Information Requested	Status	Details / Explanation
1. Table of Acceptance Criteria and Reported Device Performance	Partially Available	No formal table. The closest explicit "acceptance criteria" mentioned is related to Hematocrit: "The results were all within ±15% acceptable range" for the enlarged HCT range (20-60%). Other performance claims are general statements like "precisely" and "accurate and reliable testing results". The document focuses on substantial equivalence via comparison to a predicate device rather than presenting detailed performance against a comprehensive set of acceptance criteria.
2. Sample size for test set & data provenance	Not Available	"Pre-clinical and clinical data are employed" is stated, but no specific sample sizes for test sets, country of origin, or whether the data was retrospective/prospective are provided.
3. Number and qualifications of experts for ground truth	Not Available	Not mentioned.
4. Adjudication method for test set	Not Applicable	Not relevant for an objective measurement device like a blood glucose meter.
5. MRMC comparative effectiveness study and effect size	Not Applicable	This is a standalone diagnostic device, not an AI-assisted tool meant to improve human reader performance.
6. Standalone (algorithm only) performance	Applicable / Implicitly Done	The device itself is a standalone measurement system. The performance tests ("relevant clinical and performance tests") would assess its standalone performance. There is no concept of a separate "algorithm only" performance vs. "human-in-the-loop" once the device is operated.
7. Type of ground truth used	Not Explicitly Stated	For a blood glucose device, it would typically be a laboratory reference method (e.g., YSI analyzer), but this document does not specify the method used.
8. Sample size for the training set	Not Available	"Pre-clinical and clinical data are employed" is stated, but no specific sample sizes for training sets are provided.
9. How ground truth for the training set was established	Not Explicitly Stated	Similar to point 7, it's implied to be from clinical data, but the specific methodologies for establishing ground truth are not detailed.

In conclusion, the provided document is a regulatory submission for substantial equivalence. It highlights the device's features, intended use, and differences from a predicate device, but it lacks the detailed study results and specific acceptance criteria typically found in a dedicated performance study report.

Summary

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Image /page/0/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" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines representing movement or connection.

April 20, 2015

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

ALLIANCE INTERNATIONAL CO., LTD. JEN KE-MIN OFFICIAL CORRESPONDENT NO.54 YING TAO RD. YING DISTRICT NEW TAIPEI CITY, 239 23942, TAIWAN

Re: K132663

Trade/Device Name: i-QARE DS-W Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA Dated: March 31, 2015 Received: April 10, 2015

Dear Jen Ke-min:

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/Resourcesfor You/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) K132663

Device Name

i-QARE DS-W Blood Glucose Monitoring System

Indications for Use (Describe)

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image is a logo for Alliance+. The word "Alliance" is written in bold, black letters. Below the word is a white plus sign. The word and plus sign are superimposed on a yellow, crescent-shaped background. The logo is surrounded by a white border.

5. 510(K) Summary of Safety and Effectiveness

(Per 21 CFR 807.92)

5.1. General Information Establishment

■	The assigned 510(k) number is :	K 132663
■	Manufacturer:	Alliance International Co., Ltd.
■	Address:	No.54, Ying Tao Rd. Yinge District, New Taipei City, 239,Taiwan, R.O.C.
■	Owner Number:	9099902
■	Contact Person:	Dr. Jen, Ke-MinE-mail: ceirs.jen@msa.hinet.net(Tel)+886-2-86781007;(Fax)+886-2-86781006
●	Date Prepared:	March 27, 2015
●	Proprietary Name:	i-QARE DS-W Blood Glucose Monitoring SystemTrademark: i-QAREModel: DS-W (i.e. “DS-Walkie”)
●	Common Name:	Blood Glucose Monitoring System
●	Classification Name:	SYSTEM, TEST, BLOOD GLUCOSE,OVER THE COUNTER. Class II

Product Code: NBW

5.2. Safety and Effectiveness Information

● Predicate Device: Claim of Substantial Equivalence (SE) is made to DS-A Blood Glucose Monitoring System (K082965)

Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, i-QARE DS-W Blood Glucose Monitoring System only needs a small amount of blood. Capillary action

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Image /page/4/Picture/0 description: The image is a logo for Alliance+. The logo features the word "Alliance" in bold, black letters, stacked on top of a white plus sign. The plus sign is centered within a yellow, crescent-shaped graphic that resembles a stylized flame or wing. The entire logo is set against a white background with a thin, gray border.

亞蘭斯國際股份有限公司 Alliance International Co., Ltd.

No. 54, Ying Tao Rd., Yinge Dist, New Taipei City 239, Taiwan TEL: 886-2-8678-1007 FAX: 886-2-8678-1006 E-mail: miller.brenda@gmail.com

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.

● Intended Use:

The i-QARE DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The i-QARE DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The i-OARE DS-W Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The i-QARE DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The i-QARE DS-W Draw-in Blood Glucose Test Strip are for us with the i-QARE DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

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.

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Image /page/5/Picture/0 description: The image is a logo for an organization called "Alliance+". The word "Alliance" is written in bold, black letters, stacked on top of a plus sign. The plus sign is white and is set against a yellow, curved shape that resembles a flame or a stylized yin-yang symbol. The entire logo is enclosed in a white frame with rounded corners.

亞蘭斯國際股份有限公司 Alliance International Co., Ltd. No. 54, Ying Tao Rd., Yinge Dist, New Taipei City 239, Taiwan TEL: 886-2-8678-1007 FAX: 886-2-8678-1006 E-mail: miller.brenda@gmail.com Comparison Table

Similarities:

Item	Predicate device	Subject device
Manufacturer	Alliance International	Alliance International
ProprietaryName:	DS-A Blood GlucoseMonitoring System	i-QARE DS-W Blood GlucoseMonitoring System
510(k) No.	K082964	K132663
Indications for use	The A-CHECK DS-A BloodGlucose Monitoring System is usedwith DS-A Test Strips and 3-levelControls for the measurement ofglucose in fresh capillary wholeblood from the finger. Testing isdone outside the body ( in vitrodiagnostic use). It is indicated foruse at home ( over the counter[OTC] ) by person with diabetes, orin clinical setting by health careprofessionals, as an aid to monitorthe effectiveness of diabetescontrol. There are not intendedfor diagnosis of or screening fordiabetes mellitus, and are notintended for use on neonates.	The i-QARE DS-W Blood GlucoseMonitoring System is intended to beused for the quantitative measurementof glucose (sugar) in fresh capillarywhole blood samples drawn from thefingertips, forearm or palm. Thei-QARE DS-W Blood GlucoseMonitoring System is intended to beused by a single person and should notbe shared. The i-QARE DS-W BloodGlucose Monitoring System is intendedfor self testing outside the body (in vitrodiagnostic use) by people with diabetesat home as an aid to monitor theeffectiveness of diabetes control. Thei-QARE DS-W Blood GlucoseMonitoring System should not be usedfor the diagnosis of or screening ofdiabetes or for neonatal use. Alternativesite testing should be done only duringsteady-state times (when glucose is notchanging rapidly). The i-QARE DS-WDraw-in Blood Glucose Test Strip arefor us with the i-QARE DS-W BloodGlucose Meter to quantitatively measureglucose (sugar) in fresh capillary wholeblood samples drawn from thefingertips, forearm or palm.
Test Principle	Electrochemical biosensor withcarbon electrodes	same
Measuring Time	6 sec	same
Detecting Range	20 ~ 600 mg/dL	same
OperatingTemperature	10 to 40 °C	same
Image: Alliance logo
亞蘭斯國際股份有限公司Alliance International Co., Ltd.No. 54, Ying Tao Rd., Yinge Dist, New Taipei City 239, TaiwanTEL: 886-2-8678-1007 FAX: 886-2-8678-1006E-mail: miller.brenda@gmail.com
Strip StorageTemperature	4 to 32 °C	same
Battery Power	One 3V Lithium CR 2032 battery	same
Data Recall	By button (memory capacity: 20sets)	same

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Differences:

Item	Predicate device	Subject device
Limitations	DS-A 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,or in ahyperglycemic/hyperosmolarstate.2. Hematocrit: Variation in samplehematocrit between 30% and 55%has no significant effect on testresults. Very high (above 55%)and very low (below 30%)hematocrit can cause inaccurateresults.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 overestimationof blood glucose results.5. Therapeutic levels of L-dopa(>10mg/dL) or Dopamine (>1.25mg/dL) may result ininaccurate (elevated) glucosereadings with the system.6. Acetaminophen (<20mg/dL).	1. Apply only capillary wholeblood sample to test your bloodglucose level.2. For over-the-counter use3. Not for screening or diagnosis ofdiabetes mellitus4. Alternative site testing (AST)testing should only be doneduring steady-state times (whenglucose us not changing rapidly)5. AST should not be used tocalibrate continuous glucosemonitors (CGMs)6. AST should not be used forinsulin dose calculations7. Not for neonatal use which willcause inaccurate result.8. For single-patient use only9. The Blood Glucose MonitoringSystem is not for use in thecritically ill.10. This system should not beused on persons who are inshock, are dehydrated, or whoare hyper-osmolar.11. The following substances maycause interference at levels abovethe following concentrations:• Dopamine - 0.02 mg/dL• L-Dopa – 0.712 mg/dL• Methyldopa - 0.9 mg/dL• Uric Acid - 6 mg/dL• Triglycerides - 1900 mg/dL

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	亞蘭斯國際股份有限公司Alliance International Co., Ltd.No. 54, Ying Tao Rd., Yinge Dist, New Taipei City 239, TaiwanTEL: 886-2-8678-1007 FAX: 886-2-8678-1006E-mail: miller.brenda@gmail.com
	Ibuprofen (<40mg/dL),Tetracycline (< 0.4mg/dL),Tolbutamide (<100mg/dL),Cholesterol (<500mg/dL), andCreatinine (<30mg/dL) may notaffect the glucose meter readings.	• Ascorbic Acid - 4.7 mg/dL• Acetaminophen - 20 mg/dL• Cholesterol - 500 mg/dL12. The acceptable hematocritrange is 20-60%. If yourhematocrit is outside of thisrange, your blood glucose resultmay not be accurate.13. Please read your test stripinstructions carefully foradditional health-related
Meter Weight	56 g	46g (exclude battery )
Meter Dimension	94.5mm x 56mm x 27.5mm	47.5mm x76.5 mm x 21.9mm
Button Design	Two buttons	One button
Sample Volume	1 µL	0.7 µL
Specimen Type	capillary whole blood from thefingertip	capillary whole blood from thefingertip, palm, and forearm
Control solution	Level 1, Level 2, Level 3	Level 1, Level 2
HCT Range	30 ~ 55 %	20 ~ 60 %
Memory Storage	360 test results	20 test results
Meter Coding	Code Card	Code card free
Meter Check	Resistor (Code Card)	Built-in code (Code card free)

(1) Substantial Equivalence (SE) Discussion

Both of them have the same working principle and technologies including fresh capillary whole blood, measuring time, detecting range, operating temperature, strip storage temperature, battery power, data recall. The difference comparisons between the subject device DS-W and the predicate

device DS-A Blood Glucose Monitoring System (K082965) are as follows, 1) The subject device uses the capillary whole blood from alternate site including the palm and forearm, and the predicate device uses the capillary whole blood from fingertip only. Since the testing results of alternate site for the subject device have been validated, more sites for drawing blood bring more convenience.
1. The subject device control solutions. Level 1/Level 2 are the same as those of Level 1/Level 2 for the predicate device, which are already 510(k)-clearance. There are no safety and effectiveness concerns.
1. The subject device has 13 limitations and predicate device has 6 ones. Though more limitations mean more restrictions on usage, it leads to more accurate and reliable testing results, thus more safety is ensured.

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Image /page/8/Picture/0 description: The image is a logo for Alliance+. The logo is a white square with rounded corners. Inside the square is a yellow crescent shape with a white plus sign in the center. The word "Alliance" is written in black, bold letters above the plus sign.

亞蘭斯國際股份有限公司 Alliance International Co., Ltd. lo. 54, Ying Tao Rd., Yinge Dist, New Taipei City 239, Taiwan TEL: 886-2-8678-1007 FAX: 886-2-8678-1006 E-mail: miller.brenda@gmail.com

1. The DS-W is smaller and lighter than DS-A; and DS-W is designed to be the simplest model by the same applicant, Alliance International Co., Ltd., and DS-W is created using only one button for operation. Smaller volume and lighter weight bring more convenience on usage, i.e., fewer hazards.
1. Due to the needs of customers and market, the smaller volume of blood sample is more acceptable than 1xL, thus, DS-W develops a smaller volume of 0.71L and alternate site testing from the palm and forearm without affecting the test results.
1. The subject device enlarges the HCT range for more users to test their blood sugar in accurate results. In the HCT report, the accurate test results for the larger range have been validated. The results were all within ±15% acceptable range.
1. The design concept of DS-W is to be simple. 20 sets of memory for users to recall the latest test results without getting confused in selecting too many data of 360 sets for predicate device.
1. In order to avoid customers forgetting to code the meter and getting wrong test results, the subject device DS-W has developed Code card free function to avoid this hazard.

The subject device completed relevant clinical and performance tests. The differences between the subject device and the predicate device are not critical to the intended therapeutic, diagnostic, or surgical uses of the device. Therefore, these differences do not raise any safety and effectiveness concerns. They are substantially equivalent.

19 Conclusions:
The conclusions drawn from the clinical and the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.

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.