Glucose Control Solution for Chdiagnostics Senova™ Blood Glucose Monitoring System is intended for use to verify the performance of the Chdiagnostics Senova™ BGM System at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home. For In Vitro Diagnostic Use

Device Description

Glucose Control Solution for Chdiagnostics Senova™ is a three-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Control Solution for Chdiagnostics Senova™ provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a blue color to help users see the solution while dispensing onto a test strip. Glucose Control Solution for Chdiagnostics Senova™contains glucose values at three points within the reportable range and to verify performance of the Chdiagnostics Senova™ BGM. Glucose Control Solution for Chdiagnostics Senova™ is a non-hazardous aqueous solution containing no biological materials.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Glucose Control Solution for Chdiagnostics Senova™ Blood Glucose System." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of the device's diagnostic performance against specific acceptance criteria.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not directly addressed in the provided text. The device is a control solution, designed to verify the performance of a blood glucose monitoring (BGM) system, not a diagnostic device itself that measures a patient's condition.

Here's an attempt to answer the questions based on the available information, noting where information is not provided:

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

The document does not explicitly list acceptance criteria in terms of performance metrics (e.g., accuracy percentages, sensitivity, specificity) for the control solution itself. Instead, it describes general performance requirements that were verified.

Acceptance Criteria (Implied)	Reported Device Performance (as tested)
Closed bottle stability	Tests were conducted to verify. (Specific results not provided in this summary)
Stability after opening	Tests were conducted to verify. (Specific results not provided in this summary)
Correlation to gravimetric D-glucose	Tests were conducted to verify. (Specific results not provided in this summary)
Test precision and range	Tests were conducted to verify. (Specific results not provided in this summary) The control contains glucose values at three points within the reportable range of the Chdiagnostics Senova™ BGM.
Simulates whole blood response	Optimized to simulate the response of whole blood on the Chdiagnostics Senova™ BGM system.
Non-hazardous aqueous solution	Stated as a characteristic.
No biological materials	Stated as a characteristic.
Three-level control	Confirmed as a three-level control.
Viscosity-adjusted	Confirmed as viscosity-adjusted.
Packaged in plastic bottles with dropper tips	Confirmed.
Blue color to aid dispensing	Confirmed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the non-clinical tests (closed bottle stability, stability after opening, correlation to gravimetric D-glucose, test precision, and range). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This device is a control solution for a glucose meter. The "ground truth" for its performance would typically involve analytical chemistry methods and standardized testing protocols, such as gravimetric analysis for glucose concentration. The document does not specify the number or qualifications of experts involved in establishing this analytical ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe any adjudication method, as it's not relevant for the type of non-clinical analytical testing performed for a control solution.

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

An MRMC comparative effectiveness study is not applicable as this device is a control solution, not an AI-assisted diagnostic tool.

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

This concept is not applicable as the device is a control solution, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the glucose concentration of the control solution would likely be established through laboratory analytical methods, such as gravimetric D-glucose analysis, which is mentioned in the "Summary of non-clinical tests."

8. The sample size for the training set

This is not applicable as the device is a chemical control solution and does not involve machine learning algorithms that require a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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K032819

OCT 2 0 2003 BIONOSTICS

510(k) Summary1

(a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01432
Contact Person Kathleen Storro Director, QA & Regulatory Affairs (978) 772-7070 x 220

Date of preparation of this summary: 9 September 2003

(2) Device trade or proprietary name:
Glucose Control Solution for Chdiagnostics Senova™ Blood Glucose System

Device common or usual name or classification name:

Single Analyte Control Solution, All Types (Assayed and Unassayed)

CLASSIFICATION
PRODUCT NOMENCLATURE	NUMBER	CLASS	PANEL
SINGLE ANALYTE CONTROL SOLUTION	862.1660 75 JJX	I	CHEMISTRY

I. Substantial Equivalence

Glucose Control Solution for Chdiagnostics Senova™ is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:

Comparison of Glucose Control Solution for Chdiagnostics Senova™ to predicate devices for substantial equivalency

Characteristic	Predicate Device	Modified Device
Name:	Multi-Meter Glucose CalibrationVerification Material	Glucose Control Solution forCHDiagnostics Senova
510(k), Date:	K012430, 08/27/01
Number of levels:	5	3
Analytes:	Glucose	Glucose
Container:	plastic bottle	plastic bottle
Fill volume:	4 mL	4 mL
Color:	red	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-reactiveingredients.

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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II. Description of the new device

Glucose Control Solution for Chdiagnostics Senova™contains glucose values at three points within the reportable range and to verify performance of the Chdiagnostics Senova™ BGM.

Glucose Control Solution for Chdiagnostics Senova™ is a non-hazardous aqueous solution containing no biological materials.

(5) Intended use of the device

Glucose Control Solution for Chdiagnostics Senova™ is intended to be used to monitor and evaluate the analytical performance of the Chdiagnostics Senova™ BGM.

(6) Technological characteristics of the device.

This material consists of viscosity-adjusted, aqueous glucose control solutions prepared in three specific glucose concentrations. The solutions have been optimized to simulate the response of whole blood on the Chdiagnostics Senova™ BGM system.

(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
c) Correlation to gravimetric D-glucose
d) Test precision and range

Summary of clinical tests submitted with the premarket notification for the (b) (2) 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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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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines connecting them. The logo is black and white.

OCT 2 0 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen Storro Director, OA and Regulatory Affairs Bionostics, Inc. 7 Jackson Road Devens, MA 01432

Re: K032819

Trade/Device Name: Glucose Control Solution for Chdiagnostics Senova™ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 9, 2003 Received: September 11, 2003

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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Glucose Control Solution for Chdiagnostics Senova™ Device Name:

Indications for Use:

For In Vitro Diagnostic Use

Division Sign-Off
for Jean Cooper
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K032819
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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.