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 the Roche ACCU-CHEK brand BGM Systems listed in the package insert at glucose levels within the normal fasting blood glucose range for non-diabetic persons. This mid-level glucose concentration will complement the current, low and high glucose concentrations available in quality control products distributed by Roche Diagnostics for these same BGM systems. 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

The provided text describes a 510(k) submission for a medical device called "Glucose Meter-Check™ Control Solution for Roche ACCU-CHEK." This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria in the typical sense of a clinical trial for diagnostic performance.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or explicitly stated in the provided documentation. The acceptance criteria in this context are for demonstrating substantial equivalence based on technological characteristics and performance verification that would typically be done in a lab.

Here's an analysis based on the information provided, addressing as many points as possible:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a table of specific acceptance criteria in the traditional clinical performance sense (e.g., sensitivity, specificity thresholds) nor does it report device performance against such criteria. Instead, it focuses on verifying a few specific performance requirements for a control solution.

Acceptance Criteria (Implied / Verified)	Reported Device Performance (Summary)
Closed bottle stability	Tests were conducted to verify.
Stability after opening	Tests were conducted to verify.
Bias to glucose as determined by YSI 2300	Tests were conducted to verify.
Test precision and range	Tests were conducted to verify.
Substantial equivalence to predicate devices based on:	Comparison of technological characteristics, formulation, and intended use supports substantial equivalence.
- Net Fill	4 mL
- Color	red
- Analyte	glucose
- Container	plastic vial
- Matrix	aqueous
- Level	normal
- Mid Assigned Range	107

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for the "tests were conducted to verify" sections (closed bottle stability, open bottle stability, bias, precision, and range). These are likely laboratory-based studies. No information is provided about data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The verification tests performed for this control solution do not involve human expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. There is no mention of an adjudication method as the device is a control solution, and its performance is assessed through analytical tests, not human interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a glucose control solution, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a control solution, not an algorithm. Its performance is inherent to its chemical and physical properties.

7. The type of ground truth used

For the analytical tests (stability, bias, precision, range), the "ground truth" would be established by reference methods or established laboratory standards (e.g., YSI 2300 for glucose bias).

8. The sample size for the training set

Not applicable. This device is a control solution, and its development does not involve machine learning or a "training set" in that sense.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set mentioned or implied for this type of device.

Summary

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L081403

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510(k) Summary2

JUL 2 5 2008

(a) (1)	Submitter's name, addressBionostics, Inc.7 Jackson RoadDevens, MA 01432	Contact PersonRandy ByrdVP, Chief Technical Officer(978) 772-7070 x 272
	Date of preparation of this summary:	16 May 2008
(2)	Device trade or proprietary name:	Glucose Meter-Check™ Control Solutionfor Roche ACCU-CHEK

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" Solution 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-ChekSolution	Accu-ChekAVIVA Control	Accu-ChekACTIVEControl	Accu-ChekADVANTAGEControl	Accu-ChekCOMPACTControl	SMS GlucoseControl
510(k), Date		K04347404.27.05	K01232412.05.01	K03255209.12.03	K02217107.23.02	K07050604.18.07
Net Fill	4 mL	2.5 mL	4 mL	4 mL	3 mL	3.6 mL
Color	red	blue	clear	blue	dark blue	red
Analyte	glucose	glucose	glucose	glucose	glucose	glucose
Container	plastic vial	plastic vial	plastic vial	plastic vial	plastic vial	plastic vial
Matrix	aqueous	aqueous	aqueous	aqueous	aqueous	aqueous
Level	normal	low high	low high	low high	low high	normal
Mid Assigned Range	107	40 300	54 173	61 342	83 410	169

*Mid Assigned Range is mean of assigned ranges for each meter (Accuse 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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II. Description of the new device

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

(2) Intended use of the device

Glucose Meter-Check "Control Solution is intended for in vitro diagnostic use to assess the performance of the Roche ACCU-CHEK blood glucose test systems: Aviva, Active, Advantage and Compact and Compact Plus by healthcare professionals and in the home by people with diabetes mellitus.

(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 Roche ACCU-CHEK blood glucose test systems. 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
b) Stability after opening
Bias to glucose as determined by YSI 2300 c)
d) Test precision and range
(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

Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bionostics, Inc. c/o Mr. Randy Byrd Vice President, Chief Tcchnical Officer 7 Jackson Road Devens, MA 01432

JUL 2 5 2008

Re: K081403

Trade Name: Glucose Meter-Check™ Control Solution for Roche ACCU-CHEK Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: July 15, 2008 Received: July 16, 2008

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.

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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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.

Jean 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): K081403

Device Name: Glucose Meter-Check" Control Solution for Roche ACCU-CHEK

Indication For Use:

Glucose Meter-Check" Solution is intended to assess the performance of the following Roche ACCU-CHEK blood glucose test systems:

Roche ACCU-CHEK Advantage using Comfort Curve® test strips '

Roche ACCU-CHEK Active® ・
· Roche ACCU-CHEK Aviva®

Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus® .

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

For In Vitro Diagnostic 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) K081403

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.