Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use (i.e., for external use only) to assess the performance of blood glucose meters and test strips manufactured by TaiDoc Technology Corporation by healthcare professionals and in the home by people with diabetes mellitus. For In Vitro Diagnostic Use

Device Description

The control solutions are comprised of buffered aqueous liquid glucose control solution with viscosity modifiers to simulate certain properties of blood on the test strip and colored red to help users see the solution while dispensing onto a test strip. The control solutions are formulated to have performance comparable to those currently manufactured by TaiDoc Technology Corporation. The product is packaged in plastic bottles with dropper tips for dispensing the control solutions for use with test strips. This is a non-hazardous aqueous glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Glucose Meter-Check® Solution for TaiDoc, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Glucose Meter-Check Solution are derived from its intended use as a quality control material to assess the performance of TaiDoc blood glucose meters and test strips. The "performance" in this context refers to its ability to consistently produce glucose measurements within specified target ranges when tested on the intended meters and strips.

Characteristic / Acceptance Criteria	Reported Device Performance
Traceability of Glucose Concentration	Confirmed utilizing YSI-supplied calibrators traceable to NIST SRM 917.
Closed Bottle Stability (un-opened shelf-life)	2 years (24 months) at 15°C to 30°C (59°F to 86°F), as measured by YSI 2300 calibrated with N.I.S.T. 917 traceable materials.
Stability After Opening (percent glucose recovery)	Less than 5% change in percent glucose recovery on YSI from a single lot evaluated over 3 months (93 days in real time) when stored at ambient temperature (21-23 °C / 70-75 °F) compared to refrigerated vials (2-8 °C).
Value Assignment Range (for each lot and level)	Mean of all measurements ± 15 mg/dL (if glucose < 80 mg/dL) OR ± 15% (if glucose ≥ 80 mg/dL).
Expected Values / Reference Ranges (Target Ranges)	GOD & GDH Enzymes: - Level 1 (Low): 60-80 mg/dL (GOD), 35-65 mg/dL (GDH) - Level 2 (Normal): 100-150 mg/dL (GOD), 112-168 mg/dL (GDH) - Level 3 (High): 250-350 mg/dL (GOD), 224-336 mg/dL (GDH)

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

Sample Size for Analytical Performance Tests (Traceability, Stability, Value Assignment):
- Closed Bottle Stability: Three lots of equivalent product were used.
- Stability After Opening: Vials from a single lot were evaluated.
- Value Assignment: For each lot and level of control solution, 8 samples were measured on 5 meters using three lots of commercially distributed test strips, totaling 120 measurements (8 samples * 5 meters * 3 test strip lots = 120 measurements).
Data Provenance: The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. However, given that Bionostics, Inc. is located in Devens, MA, USA, and the submission is to the FDA, it is highly probable that the studies were conducted in the USA. The nature of stability studies and value assignment are typically prospective.

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

Experts and Qualifications: The document does not describe the use of human "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth for glucose concentrations is established through quantitative laboratory methods and traceable calibrators.
- Traceability of Glucose Concentration: NIST SRM 917 (National Institute of Standards and Technology Standard Reference Material) is used as the reference standard, indicating a highly certified and recognized ground truth.
- Measurement Devices: YSI 2300 and YSI-supplied calibrators are used, which are standard laboratory instruments for glucose measurement. The expertise lies in the certified nature of these instruments and calibrators, and the adherence to established protocols.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable in the context of this device. The 'ground truth' for glucose concentration is established through instrumental measurement and traceability to reference standards rather than expert consensus requiring adjudication.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation tasks where human readers' performance is compared with and without AI assistance to assess improved accuracy or efficiency. The Glucose Meter-Check Solution is a quality control material for in vitro diagnostic devices, not an AI diagnostic tool.

6. Standalone Performance Study

Standalone Performance: Yes, the described analytical performance studies (traceability, stability, value assignment) represent the standalone performance of the control solution. The control solution itself is tested to ensure its glucose concentrations are accurate, stable, and fall within the specified ranges, independent of a human operator's interpretation.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used is primarily traceable laboratory measurements / reference standards.
- Specifically, glucose concentration is traceable to NIST SRM 917, a highly regarded primary reference standard.
- Measurements are performed using a YSI 2300 calibrated with N.I.S.T. traceable materials, which acts as the gold standard for glucose measurement in this context.

8. Sample Size for the Training Set

Training Set Sample Size: The concept of a distinct "training set" for a machine learning algorithm is not directly applicable here, as this device is a chemical control solution, not an AI or algorithm. The "training" in this context refers to the development and formulation of the control solution to have specific characteristics and target ranges. The document states that the control solutions "are formulated to have performance comparable to those currently manufactured by TaiDoc Technology Corporation," implying an iterative development and testing process. However, specific "training set" sample sizes as defined in AI studies are not provided or relevant.

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

Training Set Ground Truth Establishment: Similar to point 8, the concept of a "training set" and its ground truth is not directly applicable in the AI sense.
- The "grounding" for the product's development and expected performance is based on the performance characteristics of predicate devices (FORA, TaiDoc Control Solutions) and the functional requirements of the TaiDoc blood glucose monitoring systems.
- The control solution is "optimized to simulate the response of whole blood on the relevant blood glucose test systems" and is formulated to contain d-glucose, the same analyte detected by the meters. This implies that the 'ground truth' for its development involved understanding the physiological range of glucose, the performance specifications of the TaiDoc meters, and the established ranges of existing control solutions.
- The "Target Ranges" for the control solution (e.g., Level 1: 60-80 mg/dL) are themselves a form of ground truth established based on clinical relevance (low, normal, high glucose levels) and the measurement capabilities of the TaiDoc meters. These ranges would have been derived from extensive testing during the development of both the meters and the control solutions.

Summary

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Quality Solutions

510(k) Summary1

K 131136

MAY 3 1 2013

(a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01434

Contact Person Randy Byrd VP, Chief Technical Officer (978) 862-1830

Date of preparation of this summary: 30 May 2013

(2) Device trade or proprietary name: Glucose Meter-Check® Solution for TaiDoc

Device common or usual name or classification name:

75 JJX, single (specified) analyte controls (assayed and unassayed)

	CLASSIFICATION
PRODUCT NOMENCLATURE	NUMBER	CLASS	PRODUCT CODCE
Quality Control Material	862.1660	I, reserved	JJX

(3) Substantial Equivalence

This quality control material is substantially equivalent in function, safety and efficacy to currently marketed devices for the same intended use:

	Fora, TaiDoc Control Solutions (GOD &GDH)	Glucose Meter-Check for TaiDoc (GOD& GDH)
510(k), date	K093724 07.29.2010	same
Net Fill	4 mL	same
Intended Use	The FORA Glucose Control Solution andTaidoc Glucose Control Solution areintended for in vitro diagnostic use (i.e.for external use only) to assess theperformance of the blood glucose testmeters and test strips manufactured byTaidoc Technology Corporation byhealthcare professionals and in thehome by people with diabetesmellitus.	Glucose Meter-Check Solution forTaiDoc is intended for in vitrodiagnostic use (i.e., for external useonly) to assess the performance ofblood glucose meters and test stripsmanufactured by TaiDoc TechnologyCorporation by healthcareprofessionals and in the home bypeople with diabetes mellitus
Color	red	same
Analyte	d-glucose	same
Container	6 mL LDPE vial with dispensing tip andcap	same
Matrix	buffered, aqueous solution with salts,viscosity modifier, preservatives andother non-reactive ingredients	same

1 This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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	Fora, TaiDoc Control Solutions (GOD & GDH)		Glucose Meter-Check for TaiDoc (GOD & GDH)
Auto QC detection	No		same
Levels	3		3
Enzyme Type	GOD	GDH	GOD	GDH
Target Ranges
	Low: 60-80	35-65	1: 60-80	35-65
	Normal: 100-150	112-168	2: 100-150	112-168
	High: 250-350	224-336	3: 250-350	224-336

Table 5.1: Summary of Equivalent Characteristics

(4) Description of the new device

This is a non-hazardous aqueous glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

Standard/Guidance Documents Referenced (if applicable):

ISO 15197:2003 In Vitro diagnostic test systems Requirements for blood glucose . monitoring systems for self-testing in managing diabetes mellitus.
. ISO 14971:2009 Medical devices – Application of risk management to medical devices
. ISO 13485:2007 Medical Devices – Quality Management Systems – Requirements for regulatory purposes
ISO 15223-1 Medical devices Symbols to be used with medical device labels, labeling . and information to be supplied - Part 1: General Requirements
. ISO 18113-4 In vitro diagnostic medical devices - Information supplied by the manufacturer (labeling) - Part 4: In vitro diagnostic reagents for self-testing
. EN 13640 Stability Testing of In Vitro Diagnostic Reagents
. Guidance for Industry and FDA Staff – Assayed and Unassayed Quality Control Material

(5) Intended use of the device

Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use (i.e., for external use only) to assess the performance and correct operation of blood glucose meters and test strips manufactured by TaiDoc Technology Corporation by healthcare professionals and in the home by people with diabetes mellitus.

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(6) Technological characteristics of the device.

This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of d-glucose and has been optimized to simulate the response of whole blood on the relevant blood glucose test systems. The solution contains no hazardous, human or animal derived components. The analyte, d-glucose, is the same as detected by the blood glucose monitoring systems for which this control is intended.

Test Principle

The BGMS with which this control solution is utilized all measure glucose concentration electrochemically in whole blood through enzymatic reactions utilizing glucose oxidase or glucose dehydrogenase enzymes.

(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.

Analytical performance

a) Traceability, stability, expected values (controls, calibrators, or methods)

Traceability

Glucose concentration is confirmed utilizing YSI-supplied calibrators traceable to NIST SRM 917.

Stability

Closed bottle stability

Stability characteristics were determined under un-opened conditions in real time stability studies on three lots of equivalent product to demonstrate an unopened shelf-life of 2 years (24 months) at the recommended storage temperatures, ranging from 15°C to 30°C (59°F to 86°F) as measured by YSI 2300 calibrated with N.I.S.T. 917 traceable materials.

Stability after opening

Glucose Meter-Check Solution for TaiDoc meets stability requirements as demonstrated by less than 5% change in percent glucose recovery on YSI on vials from a single lot evaluated over 3 months (93 days in real time) stored at ambient temperature ranging from 21 to 23 °C (70 to 75 °F) in comparison to vials of the same product stored at 2-8 °C.

Value assignment

Value assignment for each lot of product is determined as the mean of measurement on each lot and level of control solution determined from measurement of 8 samples on each of 5 meters with three lots of commercially distributed test strips for a total of 120 measurements. Value assignment range is determined as the mean of all measurements ±15 mg/dl (glucose < 80 mg/dL) or ± 15% (glucose ≥ 80 mg/dL).

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Expected values / Reference Range

The expected values for the Glucose Meter-Check for TaiDoc controls are provided on each vial of control solution.

Proposed Labeling

We have provided labeling with this submission which is sufficient and satisfies the requirements of 21 CFR Part 809.10.

(b) (2) Conclusions drawn from the clinical and non-clinical trials.

Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

May 31, 2013

Bionostics, Inc. C/O Mr. Randy Byrd 7 Jackson Road DEVENS MA 01434

Re: K131136

Trade/Device Name: Glucose Meter-Check Solution for TaiDoc Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJX Dated: April 19, 2013 Received: May 01, 2013

Dear Mr. Byrd:

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 Part 801); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for

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the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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,

Carol Carol Son -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): K131136

Device Name: Glucose Meter-Check Solution for TaiDoc

Indications For Use:

Prescription Use -- X (Part 21 CFR 801 Subpart D) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Over=The=Counter Use-(21 CFR 807 Subpart C)

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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.