The Nova StatStrip Glucose Hospital Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous and arterial whole blood. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.

Nova StatStrip Glucose Test Strips are intended for use only with the StatStrip Glucose Hospital Meter for quantitative tests. The glucose meter is intended to quantitatively measure glucose (sugar) in whole blood. The Glucose Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use only).

Nova StatStrip Control Solutions is intended for use with the Nova StatStrip Glucose Hospital Meter and Nova StatStrip Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Level 1, Level 2, and Level 3). These solutions will be offered for sale separately from the meter.

Nova StatStrip Glucose Linearity Kit solutions are used to check the linearity of the Nova StatStrip Glucose Hospital Meter System.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a glucose meter and does not contain the detailed study information typically found in a clinical trial report or a scientific publication describing device performance and acceptance criteria. The provided document is an FDA clearance letter and an Indications for Use statement.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study that proves the device meets specific criteria based solely on the provided text. The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than proof of meeting specific, pre-defined acceptance criteria in a detailed study report within this document.

For a glucose meter, acceptance criteria typically relate to accuracy (e.g., bias, precision, and agreement with a reference method as per ISO 15197 for point-of-care blood glucose monitoring systems) and other performance characteristics, but these specific criteria and the data to prove them are not in this clearance letter.

To answer your specific questions in the format requested, based only on the provided text, I can state:

Table of acceptance criteria and the reported device performance:
Not provided in this document. The document primarily concerns the FDA's substantial equivalence determination, not a detailed presentation of performance data against specific acceptance criteria.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not provided in this document.
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):
Not applicable or not provided. For a glucose meter, ground truth is typically established by laboratory reference methods (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer), not expert readers.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable or not provided.
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 is a glucose meter, not an AI-assisted diagnostic imaging device.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
A glucose meter inherently operates "standalone" in generating a quantitative reading. However, the details of its standalone performance testing (e.g., accuracy against a reference method) are not included in this document.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
While not explicitly stated in this document, for glucose meters, the ground truth is typically established using a high-precision laboratory reference method (e.g., hexokinase method on a central laboratory analyzer).
The sample size for the training set:
Not applicable or not provided. This device is likely using established electrochemical principles; modern machine learning "training sets" are not typically used for this type of device in the same way they would be for an AI algorithm.
How the ground truth for the training set was established:
Not applicable or not provided.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The eagle is positioned above a ribbon-like design. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Paul W. Mac Donald Chief Quality Assurance and Regulatory Affairs Officer Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454

APR 2 8 2006

Re: K060345

Trade/Device Name: Nova StatStrip Glucose Hospital Meter Regulation Number: 21 CFR8862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, JJX Dated: February 9, 2006 Received: February 10, 2006

Dear Mr. Mac Donald:

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) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto Gutz

Alberto Gutierrez, Ph.D. 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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Indications for Use

510(k) Number: K060345

Nova StatStrip Glucose Hospital Meter Device Name:

Indications for Use:

Nova StatStrip Glucose Linearity Kit solutions are used to check the linearity of the Nova StatStrip Glucose Hospital Meter System.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) •

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety	Page 1 of 1
§19(k)	K060345
	(Updated February 3, 2005)

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.