Glucose Meter-Check" Control Solution is intended for in vitro diagnostic use to assess the performance of the Bayer Ascensia blood glucose test systems: Breeze 2, Contour, Elite and DEX 2 by healthcare professionals and in the home by people with diabetes mellitus.

Device Description

Glucose Meter-Check" Control Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Meter-Check" Control Solution is intended for use to verify the performance of Bayer Ascensia brand blood glucose test systems listed in the package insert at glucose levels within the normal fasting blood glucose range for non-diabetic persons. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. Glucose Meter-Check" Control Solution is a non-hazardous aqueous solution containing no human or animal-derived materials.

AI/ML Overview

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

This device is a control solution for blood glucose meters, not a diagnostic device that produces patient-specific measurements. Therefore, the acceptance criteria and study design are different from what would be expected for a diagnostic algorithm or imaging device. The "performance" being evaluated is the stability and consistent behavior of the control solution itself when tested on the specified blood glucose meters.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state formal "acceptance criteria" for the control solution in terms of specific numerical thresholds for accuracy, sensitivity, or specificity. Instead, the performance is demonstrated through comparison to predicate devices and verification tests, focusing on stability and consistent response within the expected range for a normal glucose level control.

Aspect Tested	Reported Device Performance
Closed Bottle Stability	Tests were conducted to verify specific performance requirements.
Stability After Opening	Tests were conducted to verify specific performance requirements.
Test Mean Response Data	Tests were conducted to verify specific performance requirements. (Mean Assigned Value: 86 mg/dL on Ascensia Contour)
Precision Data	Tests were conducted to verify specific performance requirements.
Substantial Equivalence	Demonstrated through comparison of technological characteristics, formulation, and intended use to predicate devices.

Note on "Acceptance Criteria": For control solutions, acceptance criteria typically relate to the stability of the analyte (glucose in this case) over time and under various storage conditions. The goal is for the control solution to consistently produce a reading on the target glucose meter that falls within a predefined acceptable range (often provided by the meter manufacturer). The summary states that tests were run to "verify specific performance requirements," implying these criteria were met, but the specific numerical targets for stability are not detailed in this public summary.

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

The document does not specify a "test set" in the context of patient data or algorithm performance. The "tests" mentioned are non-clinical studies on the control solution itself.

Sample Size: Not applicable in the traditional sense of patient samples. The "samples" would be aliquots of the control solution tested on the blood glucose meters. The number of such tests or batches is not disclosed.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for a non-clinical control solution study. These tests would have been performed by the manufacturer, Bionostics, Inc., likely in their facilities in Devens, MA, USA. They are prospective in the sense that they were designed to evaluate the product.

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

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

For a control solution, the "ground truth" for the declared glucose concentration is typically established by manufacturing specifications, internal quality control, and analytical methods (e.g., traceable reference methods) to determine the actual glucose concentration within the control solution. This is not typically done by "experts" reviewing patient data. The "ground truth" for the meter's performance is that it should read the control solution within an expected range.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable.

This type of study does not involve expert adjudication of results. The results are quantitative measurements of glucose on blood glucose meters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC study was not done.

MRMC studies are relevant for diagnostic devices where human readers interpret medical images or data. This device is a control solution for an in vitro diagnostic device (blood glucose meter), which is used to verify the meter's performance.

Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Study: Yes, in a way. The "device" being evaluated is the control solution itself. Its performance is entirely "standalone" in that it is evaluated for its inherent properties (stability, consistency) when used by the blood glucose meters per their instructions. There's no AI algorithm involved. The control solution itself doesn't have "human-in-the-loop" performance; it's a reagent.

7. The Type of Ground Truth Used

For the Glucose Meter-Check™ Control Solution:

Type of Ground Truth: The "ground truth" for the control solution itself is its analytically determined glucose concentration (0.1% w/v glucose) and its stability. This would be established by the manufacturer using established analytical chemistry methods and Quality Control procedures, likely traceable to a primary reference standard. The "Mid Assigned Value" (e.g., 86 mg/dL for Ascensia Contour) serves as the expected reading for that specific meter.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable.

This is not an AI/machine learning device that requires a training set.

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

How Ground Truth for Training Set Was Established: Not applicable.

Summary

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1082395

SEP 1 8 2008

510(k) Summary2

BIONOSTIC

Quality Solutions

Contact Person Submitter's name, address (a) (1) Bionostics, Inc. Kathleen Storro Sr. Dir. QA/RA 7 Jackson Road (978) 772-7070 x 220 Devens, MA 01434 18 August 2008 Date of preparation of this summary: Glucose Meter-Check™ Control Solution (2) Device trade or proprietary name: For Bayer Ascensia Blood Glucose Test Systems
Device common or usual name or classification name:

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

	CLASSIFICATION
PRODUCT NOMENCLATURE	NUMBER	CLASS	PANEL
SINGLE ANALYTE CONTROL SOLUTION	862.1660	1	75 CLINICAL CHEMISTRY

l. Substantial Equivalence

Glucose Meter-Check" Control Solution for Bayer Ascensia Blood Glucose Test Systems is substantially equivalent in function, safety and efficacy to currently marketed devices for the same intended use:

Comparison of Glucose Meter-Check Control Solution to predicate devices for substantial equivalency

Product	GlucoseMeter-CheckSolution	AscensiaBreeze 2	AscensiaContour	AscensiaElite	AscensiaDEX 2	SMS GlucoseControl
510(k), Date		K06234711-21-06	K02365705-11-04	K04331112-22-04	K02358411-20-02	K07050604-18-07
Net Fill	4 mL	2.5 mL	2.5 mL	2.5 mL	2.5 mL	3.6 mL
Color	red	red	red	red	red	Red
Analyte	glucose	glucose	glucose	glucose	glucose	Glucose
Glucose (% w/v)	0.1%	0.10%	0.12%	0.10%	0.15%	0.12%
Container	plastic vial	plastic vial	plastic vial	plastic vial	plastic vial	plastic vial
Matrix	aqueous	aqueous	aqueous	aqueous	aqueous	aqueous
Level	normal	normal	normal	normal	normal	normal
Mid AssignedValue* (mg/dL)	86	108	122	88	140	110

Mid Assigned Value is the mean of assigned values for each meter (Ascensia Contour for Glucose Meter-Check and SMS Glucose Control)

2 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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ll. Description of the new device

Glucose Meter-Check" Control Solution is a non-hazardous aqueous solution containing no human or animal-derived materials.

Intended use of the device (a) (1)

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

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 Bayer Ascensia blood glucose test systems. The solution contains no hazardous, human or animal derived components.

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

Tests were conducted to verify specific performance requirements:

a) Closed bottle stability
b) Stability after opening
c) Test mean response and precision data
Summary of clinical tests submitted with the premarket notification for the device. (b) (2) 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bionostics, Inc. c/o Ms Kathleen Storro 7 Jackson RD. Devens, MA 01434

SEP 1 8 2008

K082395 Re:

Trade/Device Name: Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucosc Test Systems Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Codes: JJX Dated: August 18, 2008 Received: August 20, 2008

Dear Ms. Storro:

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 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.v.M.

Yean M. Cooper, M.S., D.V.M. 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): K082395

Device Name: Glucose Meter-Check" Control Solution for Bayer Ascensia Blood Glucose Test Systems

Indication For Use: Glucose Meter-Check" Control Solution is intended to assess the performance of the following Bayer blood glucose test systems:

Bayer Ascensia Breeze® 2 .
Bayer Ascensia Contour® .
Bayer Ascensia Elite® .
Bayer Ascensia DEX® 2

The Meter-Check Glucose Control Solution is intended for use by healthcare professional and people with diabetes mellitus at home.

For In Vitro Diagnostics Use

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

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

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Anr Chappie

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

510(k) K082395

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.