Glucose Control Solution for BD Latitude™ Blood Glucose Monitoring System is intended for use to verify the performance of the BD Latitude™ 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 BD Latitude™ is a three-level, viscosityadjusted, aqueous liquid glucose control solution. Glucose Control Solution for BD Latitude™ 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 BD Latitude™ contains glucose values at three points within the reportable range and verifies performance of the BD Latitude ™ BGM.

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Glucose Control Solution for BD Latitude™:

The provided document is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and performance data in the format of a typical study report. Therefore, direct answers to all your questions are not explicitly available or are inferred from the context of a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not present a formal table of acceptance criteria with specific numerical targets and corresponding performance results. Instead, it lists the types of tests conducted to ensure performance requirements are met, implying that the results of these tests demonstrated acceptable performance relative to existing, legally marketed predicate devices.

Acceptance Criteria Type (Inferred)	Reported Device Performance
Closed Bottle Stability	Tests conducted to verify specific performance requirements. (Implied acceptable stability for shelf life)
Stability After Opening	Tests conducted to verify specific performance requirements. (Implied acceptable stability for use life)
Correlation to Gravimetric D-Glucose	Tests conducted to verify specific performance requirements. (Implied acceptable correlation to a reference method)
Test Precision and Range	Tests conducted to verify specific performance requirements. (Implied acceptable precision and accurate glucose values within the reportable range of the BD Latitude™ BGM)
Manufacturing Process (as per predicate)	Substantially equivalent to predicate device in characteristics, formulation, and intended use.

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

The document does not specify the sample sizes used for the non-clinical tests. It only states that "Tests were conducted to verify specific performance requirements." Similarly, it does not provide details on the data provenance (e.g., country of origin, retrospective/prospective), as this level of detail is typically not included in a 510(k) summary that focuses on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not provided. For a control solution, "ground truth" would typically refer to the accurately measured glucose concentrations within the control solutions themselves. This is established through rigorous analytical chemistry methods rather than expert consensus on diagnostic images or clinical assessments.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of diagnostic data (e.g., medical images) where there can be inter-reader variability. For a chemical control solution, the 'ground truth' values are determined analytically, not through human adjudication.

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

No. An MRMC study is not relevant for a glucose control solution. This type of study is used to evaluate the impact of an AI system on human reader performance in diagnostic tasks.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The device is a glucose control solution, not an algorithm. Therefore, a standalone algorithm performance study is not applicable. The "performance" of this device is its ability to provide stable, accurate, and consistent glucose values that can be used to verify the performance of a blood glucose meter. The non-clinical tests assess these inherent properties.

7. The Type of Ground Truth Used

The ground truth for the control solution's glucose concentration would be established through gravimetric D-glucose (as mentioned in the summary, "Correlation to gravimetric D-glucose"). This is a highly accurate chemical reference method for determining glucose concentration.

8. The Sample Size for the Training Set

Not applicable. The device is a chemical control solution, not an AI/ML algorithm that requires 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.

In summary, the provided 510(k) summary focuses on demonstrating that the Glucose Control Solution for BD Latitude™ is substantially equivalent to a legally marketed predicate device. It explicitly states that "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence." The non-clinical tests listed (stability, correlation to gravimetric D-glucose, precision, and range) are the types of studies typically performed to ensure the quality and reliability of a control solution, but the detailed results and specific acceptance criteria are not presented in this summary document.

Summary

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JUL 12 2002

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510(k) Summary*

Submitter's name, address (a) (1) 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: 17 May 2002

(2) Device trade or proprietary name:	Glucose Control Solution forBD Latitude™ Blood Glucose System
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Device common or usual name or classification name:

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

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

Substantial Equivalence (3)

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

Comparison of Glucose Control Solution for BD Latitude™ to predicate devices for substantial equivalency

Characteristic	Predicate Device	Modified Device
Name:	Multi-Meter Glucose CalibrationVerification Material	Glucose Control Solution for BDLatitude
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-	Buffered, aqueous solution of D-
	Glucose, viscosity modifier,	Glucose, viscosity modifier,
	preservatives and other, non-	preservatives and other, non-reactive
	reactive ingredients.	ingredients.

· Devens, MA USA 01432 · · (978) 772-7070 · Fax: (978) 772-7072 7 Jackson Road

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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(4) Description of the new device

Glucose Control Solution for BD Latitude™ contains glucose values at three points within the reportable range and verifies performance of the BD Latitude ™ BGM.

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

(5) Intended use of the device

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

Technological characteristics of the device. (6)

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 BD Latitude™ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

JUL 12 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850 .

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

K021697 Re:

Trade/Device Name: Glucose Control Solution for BD Latitude™ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: May 17, 2002 Received: May 22, 2002

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 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); 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.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Glucose Control Solution for BD Latitude™ Device Name:

Indications for Use:

For In Vitro Diagnostic Use

Scan Coper

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K021697

(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) Over-The-Counter Use

(Optional Format 1-2-96)

510(K) BD LATITUDE

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.