RNA GLA Glucose Calibration Verification Control assayed controls are intended for use to verify the performance of multiple blood glucose meters as indicated on the package insert at their upper and lower ends of reportable range and at three points within the range. These controls can therefore be used to assess the linearity and calibration of the test system, or to verify the test systems' performance.

For In Vitro Diagnostic Use

Device Description

RNA GL4 Glucose Calibration Verification Control is a seven-vial, viscosityadjusted, aqueous liquid glucose control linearity set which provides two, five-level CVC sets, optimized for use with MediSense Point of Care blood glucose systems PCx and i-STAT 1 using Precision PCx or Precision PCx Plus test strips. RNA GL4 Glucose Calibration Verification Control 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 red color to help users see the solution while dispensing onto a test strip.

RNA GL4 Glucose Calibration Verification Control contains glucose values at the lower and upper limits of reportable range as well as three points within the range and therefore, may be used to assess the linearity and calibration, or verify performance of the blood glucose systems listed on the package insert.

RNA GL4 Glucose Calibration Verification Control is a non-hazardous aqueous solution containing no biological materials.

AI/ML Overview

The provided text describes the Bionostics RNA GL4 Glucose Calibration Verification Control, a device used to verify the analytical performance of blood glucose meters. It does not contain information about acceptance criteria or a specific study designed to prove the device meets these criteria in the manner one would expect for a diagnostic or AI device.

However, based on the information provided, here's a breakdown of what can be extracted, and where there are gaps in relation to your request:

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

The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., accuracy, precision limits) for the RNA GL4 Glucose Calibration Verification Control. It mentions the "intended use to verify the analytical performance" and to "assess the linearity and calibration, or verify performance."

The device performance is described by its characteristics and its ability to provide specific glucose concentrations.

Acceptance Criteria (Implied)	Reported Device Performance
Verification of Analytical Performance	Intended for use to verify the analytical performance of certain blood glucose meters (PCx and i-STAT 1).
Assessment of Linearity and Calibration	Contains glucose values at the lower and upper limits of reportable range as well as three points within the range, allowing for assessment of linearity and calibration.
Specific Glucose Concentrations	Provides seven specific glucose concentrations optimized to simulate whole blood response for listed blood glucose meters/test strips.
Stability	Accelerated aging studies on most labile analytes, together with real time experience with products with similar formulations, support stability claim.
Precision	Test precision was conducted. (No specific results provided).
Correlation to Reference Methodology	Correlation to reference methodology was conducted. (No specific results provided).

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 a "test set" in the context of a study with a sample size for evaluating the device's performance against clinical data or a ground truth. Instead, it discusses:

Accelerated aging studies and real-time experience: This implicitly involves testing the product over time, but no sample sizes or data provenance are mentioned.
Test precision: This refers to internal testing of the control solution itself, not a test set of patient samples. No sample size is given.
Correlation to reference methodology: This also refers to internal testing of the control. No sample size or data provenance is given.

This device is a calibration verification control, meaning it's a known standard used to check the performance of a blood glucose meter, not a diagnostic device that processes patient samples to generate an output. Therefore, the concept of a "test set" with patient data as typically understood for a diagnostic algorithm is not directly applicable here.

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

Not applicable. As this is a control solution, the "ground truth" for its own stated glucose concentrations would be established through precise chemical analysis and manufacturing controls, not through expert consensus on patient data.

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

Not applicable. There is no "test set" involving patient data and multiple readers or experts to require an adjudication method.

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 calibration control, not an AI-powered diagnostic tool, and therefore MRMC studies with human readers are irrelevant.

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

Not applicable. This is not an algorithm or AI device. It's a laboratory reagent.

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

The "ground truth" for the RNA GL4 Glucose Calibration Verification Control itself would be the analytically determined and precisely manufactured concentrations of glucose in each of its seven solutions (A through G). These concentrations are specified as "target midpoint values" (e.g., 40 mg/dL, 103 mg/dL, 440 mg/dL). This is established through rigorous chemical and metrological standards, not expert consensus on pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device is a control solution, not a machine learning model, so there is no training set.

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

Not applicable. There is no training set for this product.

Summary

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1621624

JUL 12 2002

BIONOS

510(k) Summary*

(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: 15 May 2002

(2) Device trade or proprietary name:	RNA GL4 GlucoseCalibration Verification Control
---------------------------------------	-----------------------------------------------------

Device common or usual name or classification name:

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

PRODUCT NOMENCLATURE	CLASSIFICATIONNUMBER	CLASS	PANEL
SINGLE ANALYTE CONTROL SOLUTION	862.1660 75 JJX	1	CHEMISTRY

(3) Substantial Equivalence

RNA GL4 Glucose Calibration Verification Control is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:

Comparison of Multi-Meter Glucose Calibration Verification Material to predicate devices for substantial equivalency

Characteristic	Predicate Devices	Modified Device
Name:	Multi-Meter GlucoseCalibration VerificationMaterial	RNA Medical GlucoseCalibration VerificationControl
510(k), Date:	K012430, 08/27/01	K002540, 09/18/00
Number of levels:	5*	5**7 vials per kit, only 5 levelsfor use on specific devices
Analytes:	Glucose	Glucose
Container:	plastic bottle	plastic bottle
Fill volume:	4 mL	4 mL
Color:	red	red
Matrix:	Buffered, aqueous solutionof D-Glucose, viscositymodifier, preservatives andother, non-reactiveingredients.	Buffered, aqueous solutionof D-Glucose, viscositymodifier, preservatives andother, non-reactiveingredients.

* 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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Description of the new device (4)

Strip Type	Solution A	Solution B	Solution C	Solution D	Solution E	Solution F	Solution G
PCx Plusstrip lots beginningwith "6"	40Level 1	--	120Level 2	220Level 3	290Level 4	370Level 5	--
PCxstrip lots beginningwith "1"	--	40Level 1	103Level 2	--	249Level 3	324Level 4	440Level 5

Target midpoint values for Precision PCx and Precision PCx Plus test strips

RNA GL4 Glucose Calibration Verification Control is a non-hazardous aqueous solution containing no biological materials.

(5) Intended use of the device

RNA GL4 Glucose Calibration Verification Control is intended for use to verify the analytical performance of certain blood glucose meters as listed on the package insert.

(6) Technological characteristics of the device.

This material consists of viscosity-adjusted, aqueous glucose control solutions prepared in seven specific glucose concentrations. The solutions have been optimized to simulate the response of whole blood for the blood glucose meters in combination with test strips, listed in the package insert.

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

Tests were conducted to verify specific performance requirements:

a) Accelerated aging studies on most labile analytes, together with real time experience with products with similar formulations and failure mode to support stability claim.
b) Test precision
c) Correlation to reference methodology
Summary of clinical tests submitted with the premarket notification for the (b) (2) device.

N/A

Conclusions drawn from the clinical and non-clinical trials. (b) (3)

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/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is a stylized symbol that resembles three wavy lines or a caduceus without the staff.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 2 2002

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

Re: K021624

Trade/Device Name: RNA GL4 Glucose Calibration Verification Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: May 15, 2002 Received: May 16, 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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Page 2 -

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/cdrh/dsmaldsmamain.html".

Sincerely yours,

Steven Putman

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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KO21624 510(k) Number:

RNA GL4 Glucose Calibration Verification Control Device Name:

Indications for Use:

For In Vitro Diagnostic Use

Sean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number.

(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) PREMARKET NOTIFICATION – GL4 Glucose CVC

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.