GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE

K112356 · Bionostics, Inc. · JJX · Sep 19, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112356
• Device Name: GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE
• Applicant: Bionostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The Glucose Meter-Check Control Solution for AgaMatrix is intended for use to verify the performance and correct operation of the AgaMatrix blood glucose monitoring test systems utilizing the WaveSense family of blood glucose test strips. Glucose Meter-Check Control Solution for AgaMatrix is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro Diagnostic Use.

Device Story

Glucose Meter-Check Control Solution is a buffered, aqueous D-glucose solution used to verify the performance of AgaMatrix blood glucose monitoring systems. It simulates whole blood response on WaveSense test strips. Used by healthcare professionals and patients with diabetes at home; the user applies the control solution to the test strip in the same manner as a blood sample. The meter provides a reading that the user compares against the target range provided by the manufacturer. If the result falls within the expected range, the system is operating correctly. This verification helps ensure the accuracy of glucose monitoring, supporting reliable clinical decision-making for diabetes management.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (closed/open bottle, transport) performed using YSI 2300 analyzer. Value assignment validated across multiple test strip lots and meters; >95% of measurements fell within assigned ranges.

Technological Characteristics

Buffered aqueous solution of D-glucose, viscosity modifier, preservatives. 6 mL LDPE vial, 4 mL fill volume. Traceable to high-precision gravimetry and calibrated instrumentation. Standards: ISO 15197, ISO 14971, ISO 13485, ISO 15223-1, ISO 18113, EN 13640.

Indications for Use

Indicated for healthcare professionals and people with diabetes mellitus to verify the performance and correct operation of AgaMatrix blood glucose monitoring test systems using WaveSense test strips.

Regulatory Classification

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.

Predicate Devices

• WaveSense Control Solution (K052762)

Submission Summary (Full Text)

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# 510(k) Summary1

SEP 1 9 2011

- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01434
Contact Person Randy Byrd VP, Chief Technical Officer [phone] x 272

Date of preparation of this summary: 15 August 2011

- (2) Device trade or proprietary name: Glucose Meter-Check Control for AgaMatrix
### Device common or usual name or classification name:

אר Single (Specified) Analyte Control, All Types, Assayed and Unassayed

| 11 11 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1<br>REGULATION MEDICAL | REGULATION | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------|------------------------|
| SPECIALTY | NUMBER<br>A BREAK SERVICE - In The CONSULT - In Comments of Children Comments of Children | CLASS | REGULATION DESCRIPTION |
| Chemistry | 862.1660 | | Glucose Control |

#### l. Substantial Equivalence

Glucose Meter-Check Control Solution for AgaMatrix substantially equivalent in function, safety and efficacy to currently marketed devices for the same intended use as shown in the following tables:

| Characteristic | Predicate Device | Modified Device |
|-------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Name: | WaveSense Control Solution | Glucose Meter-Check Control Solution for AgaMatrix |
| 510(k), Date: | K052762, Jan 23 2006 | |
| Number of levels: | 2, typical fasting glucose and high, elevated blood glucose | 1, typical fasting glucose |
| Target ranges: | 111-169 and 298-448 mg/dL | 105-158 mg/dL |
| Analytes: | glucose | glucose |
| Container: | 6 mL LDPE vial with dispensing tip and cap | 6 mL LDPE vial with dispensing tip and cap |
| Fill volume: | 4 mL | 4 mL |
| Color: | blue | blue |
| Matrix: | Buffered, aqueous solution of D-Glucose, viscosity modifier, preservatives and other, non-reactive ingredients. | Buffered, aqueous solution of D-Glucose, viscosity modifier, preservatives and other, non-reactive ingredients. |
| Brands: | WaveSense | Glucose Meter-Check |

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

K112356

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#### II. Description of the new device

Glucose Meter-Check Control Solution for AgaMatrix is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Control Solution is formulated for optimal performance on AgaMatrix glucose meters utilizing the WaveSense family of test strips.

#### (a) (1) Intended use of the device

The Glucose Meter-Check Control Solution for AgaMatrix is intended for use to verify the performance and correct operation of the AgaMatrix blood glucose monitoring test systems utilizing the WaveSense family of blood glucose test strips. Glucose Meter-Check Control Solution for AgaMatrix is intended for use by healthcare professionals and people with diabetes mellitus at home.

#### (a) (2) Technological characteristics of the device.

This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose with recovery on the test systems in the range typically considered normal, fasting glucose for a non-diabetic person. This solution has been optimized to simulate the response of whole blood on the blood glucose test systems manufactured by AgaMatrix and utilizing the WaveSense family of blood glucose test strips. The solution contains no hazardous, human or animal derived components.

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

Tests were conducted to verify specific performance requirements:

- a) Closed bottle stability (Shelf-life)
- b) Stability after opening (Use-life)
- c) Transport Stability
- d) Test response
- (b) (2) Summary of clinical tests submitted with the premarket notification for the device. N/A

#### (b) (3) 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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Public Health Service

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

Bionostics, Inc. c/o Mr. Randy Byrd Chief Technical Officer 7 Jackson Road Devens. MA 01434

SEP 1 9 2017

Re: k112356

Trade Name: Glucose Meter-Check Control Solution for AgaMatrix Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I. reserved Product Codes: JJX Dated: August 15. 2011 Received: August 16, 2011

Dear Mr. Byrd,

We have reviewed vour 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 either class II (Special Controls) or class III (PMA), 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 vour 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 Imited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809): medical device 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), picase contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. 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 [phone]. For questions regarding 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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours.

signature

Courtney H. Lias, 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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## Indications for Use

510(k) Number: Device Name: Indications for Use:

K112356 Glucose Meter-Check® Control Solution for AgaMatrix The Glucose Meter-Check Control Solution for AgaMatrix is intended for use to verify the performance and correct operation of the AgaMatrix blood glucose monitoring test systems utilizing the WaveSense family of blood glucose test strips. Glucose Meter-Check Control Solution for AgaMatrix is intended for use by healthcare professionals and people with diabetes mellitus at home.

: -

For In Vitro Diagnostic Use

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

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

AND/OR

Concurrent of CDRH, Office of Device Evaluation (OIVD)

Signature

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

510(k) k112356

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