Nova Max Plus Glucose and β-Ketone Control Solutions are intended for use with the Nova Max Family of Monitors (Nova Max, Nova Max Plus, and Nova Max Link), BD Logic and Paradigm Link Monitors, Nova Max Glucose Test Strips, and Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood Glucose and ß-Ketone test results. There are two levels of Nova Max Plus Glucose and ß-Ketone Control Solutions (Mid and High).

Nova Max Plus Glucose and ß-Ketone Control Solutions are for in vitro diagnostic use ONLY (for testing outside the body).

Device Description

Nova Max Plus Glucose and β-Ketone Control Solutions are intended for use with the Nova Max Family of Monitors (Nova Max, Nova Max Plus, and Nova Max Link), BD Logic and Paradigm Link Morr yours, Nova Max Glucose Test Strips, and Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood Glucose and fl-Ketone test results. There are two levels of Nova Max Plucose and B-Ketone Control Solutions (Mid and High).

Nova Max Plus Glucose and B-Ketone Control Solutions are for in vitro diagnostic use ONLY (for testing outside the body).

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Nova Max Plus Glucose and β-Ketone Control Solutions.

The provided document describes a 510(k) submission for Nova Max Plus Glucose and β-Ketone Control Solutions, a Class I medical device (quality control material). As such, the information typically provided for more complex Class II or Class III devices regarding clinical trials, extensive performance metrics, and human reader studies is not applicable or present in this type of submission for a control solution.

The acceptance criteria here refer to the product demonstrating substantial equivalence to predicate devices. The study conducted primarily focuses on bench testing to support this claim, rather than clinical efficacy or diagnostic accuracy in patients.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a quality control solution and a 510(k) submission for a Class I device, "acceptance criteria" here relate to demonstrating that the new control solutions perform comparably to previously cleared predicate device components and are safe and effective for their intended use. The performance is assessed through laboratory studies.

Acceptance Criteria (Implied)	Reported Device Performance
Pertains to control solutions for glucose and β-ketone:	All studies were performed, and results support the conclusion of substantial equivalence:
1. Functional equivalency to predicate device components	The proposed Nova Max Plus Glucose and β-Ketone Control solutions use the same fundamental scientific technology and have the same intended use as the previously cleared predicate device components: Nova Max Plus Blood Glucose and β-Ketone Monitor System (K091547) and Nova Max Blood Glucose Monitor (K070255).
2. Stability of control solutions	Stability studies were performed. (Specific results or duration not detailed in this summary).
3. Reproducibility/Accuracy in relevant test systems	Averages in equivalency studies were performed. (Specific results or metrics not detailed, but imply comparison to expected values or predicate performance). The device measures Glucose and β-Ketone electrochemically, where the magnitude of current is proportional to the amount of analyte, providing a quantitative measure in control solutions.
4. No new concerns for safety and effectiveness	Results of laboratory testing demonstrate that the performance of the Nova Max Plus Glucose and β-Ketone Control Solutions is "comparable to the performance of the previously cleared predicate devices." The device utilizes the same fundamental scientific technology and has the same intended use. "There are no new concerns for safety and effectiveness that have been shown through testing." This implies that testing did not reveal any unexpected adverse performance or safety issues compared to predicates.
5. Adherence to general controls and regulatory requirements	The device is classified as Class I (21 CFR 862.1660 and 862.1435) with product codes JJX, JIN. The FDA's substantial equivalence determination implies compliance with necessary general controls (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).

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

Sample Size: The document does not specify a numerical sample size for the "test set." It broadly refers to "stability studies" and "averages in equivalency studies" being performed in the laboratory. For a control solution, the "test set" would refer to the batches of control solution produced and tested, as well as the number of measurements taken. This detail is not provided.
Data Provenance: The studies were conducted "in the laboratory." Given the submitter's address (Waltham, MA, U.S.A.) and the context of a U.S. FDA 510(k) submission, the data is presumably derived from retrospective internal laboratory testing conducted by Nova Biomedical Corporation in the U.S.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts & Qualifications: This category is not applicable in the traditional sense for this device. For quality control solutions, "ground truth" is typically established by certified reference materials, analytical chemistry methods, or the manufacturing specifications and target values for the control. The document refers to the proposed solutions being for "in vitro diagnostic use ONLY." The "averages in equivalency studies" would likely compare the control solutions' measured values to these pre-defined target values or to the performance of predicate controls, as determined by laboratory experts, not clinical experts for diagnostic accuracy. No specific number or qualifications of experts for "ground truth" are mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: This concept is generally not applicable for a quality control solution. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations (e.g., radiologists reading images). Here, "performance studies" would involve comparing quantitative measurements against established norms or predicate device performance, which is a direct measurement and comparison rather than a subjective interpretation requiring adjudication.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging or interpretation devices, particularly those involving AI. The device in question is a quality control solution, not an AI-powered diagnostic tool.

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

Standalone Performance: This concept is not applicable to this device. A standalone (algorithm-only) performance is relevant for AI or automated diagnostic algorithms. The Nova Max Plus Glucose and β-Ketone Control Solutions are chemical solutions used to verify the accuracy of a monitor system; they do not have an "algorithm-only" performance in the way an AI diagnostic tool would. Their performance is inherent in their chemical composition and stability when measured by the intended monitor.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground-truth for quality control solutions is typically based on certified reference values, analytical standards, or established manufacturing targets for the glucose and β-ketone concentrations. The document implies that the device's performance, as measured by the monitor, is compared to these predetermined values or the performance of predicate controls, which represent the "ground truth" for what the control solution should measure. The text mentions "averages in equivalency studies," which would rely on such established truth.

8. The Sample Size for the Training Set

Sample Size for Training Set: This is not applicable. This device is a quality control solution. It is manufactured, not "trained" in the context of machine learning or AI. Performance studies for control solutions involve batch testing, stability testing, and equivalency testing, but not a "training set" like an algorithm would require.

9. How the Ground Truth for the Training Set was Established

How Ground Truth for Training Set was Established: This is not applicable as there is no "training set" for a quality control solution.

Summary

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5. 510(k) Summary

510(k) Summary

(as required by 21 CFR 807.92)

AUG 2 7 2010

Submitter:	Nova Biomedical Corporation200 Prospect StreetWaltham, MA 02454 U.S.A.
Correspondent:	Paul W. MacDonaldChief Quality Assurance and Regulatory Affairs Officer
Phone:Fax:Email:	781-894-0800 x211781-891-4806pmacdonald@novabio.com
Device Name:	Nova Max Plus Glucose and β-Ketone Control Solutions
Common Name:	Single (Specified) Analyte Controls (Assayed And Unassayed)
Classification:	Clinical Chemistry and Clinical Toxicology DevicesClinical ChemistrySingle (Specified) Analyte Controls (Assayed And Unassayed)Class I per 21 CFR 862.1660Nitroprusside, Ketones (Urinary, Non-Quant.)Class I per 21 CFR 862.1435
Product Codes:	JJX, JIN
Predicate Devices:	Nova Max Plus Blood Glucose and B-Ketone Monitor System, K09154Nova Max Blood Glucose Monitor, K070255

Description of the Device:

Intended Use/Indications for Use:

Nova Max Plus Glucose and β-Ketone Control Solutions are intended for use with the Nova Max Family of Monitors (Nova Max, Nova Max Plus, and Nova Max Link), BD Logic and Paradigm Link Morr yours, Nova Max Glucose Test Strips, and Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood Glucose and fl-Ketone test results. There are two levels of Nova Max Plucose and B-Ketone Control Solutions (Mid and High).

Nova Max Plus Glucose and B-Ketone Control Solutions are for in vitro diagnostic use ONLY (for testing outside the body).

Summary of Technological Characteristics:

The proposed Nova Max Plus Glucose and ß- Ketone Control Solutions measures Glucose and ß-Ketone electrochemically. The magnitude of the current is proportional to the amount of Glucose or, 8hydroxybutyrate (ß- Ketone) present in the sample, providing a quantitative measure of Glucose or ß-Ketone in whole blood, or control solutions.

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Comparison to Predicate Devices:

The proposed Nova Max Plus Glucose and p-Ketone Control solutions use the same fundamental scientific technology and have the same intended use as the some in the same findamental sciences Nova Max Plus Blood Clucose and B-Ketone Monitor Speviously cleared in the predicate
Nova Max Plus Blood Glucose and B-Ketone Monitor System (K091547), and the predicate Nova Blood Glucose Monitor (K070255).

Performance Studies:

The performance of the Nova Max Plus Glucose and β-Ketone control solutions has been studied in the laboratory. Stability studies, aren's in equivalency studies have all been studied in the results support the conclusion of substantial equivalence to the all been performed. All.
results support the conclusion of substantial equivalence to the currently markete

Conclusion:

Results of laboratory testing demonstrate that the performance of the Nova Max Plus Glucose and B-Ketone Control Solution of any and the performatice of the Nova Wax Philose and Jpreviously cleared predices devices . In addition . H previously cleared predicate devices. In addition, the proposed device utilizes the same fundamed with scientific technology, and has the intended inte as the previously cleared predicate devices. There are no new concerns for safety and effectiveness that have been shown through testing.

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing the department's focus on health, well-being, and human services. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Nova Biomedical Corporation c/o Mr. Paul W. MacDonald Regulatory Affairs Specialist 200 Prospect Street Waltham, MA 02454

AUG 2 7 2010

Re: K101633

Trade Name: Nova Max Plus Glucose and B-Ketone Control Solutions Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material Regulatory Class: Class I, reserved Product Codes: JJY Dated: July 20, 2010 Received: July 21, 2010

Dear Mr. MacDonald:

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 I vard to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Courtney C. Harper, 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

K101633

Indications for Use

510(k) Number:

K101633

Device Name:

..............................................................................................................................................................................

Nova Max Plus Glucose and B-Ketone Control Solutions

Indications for Use:

Nova Max Plus Glucose and ß-Ketone Control Solutions are for in vitro diagnostic use ONLY (for testing outside the body).

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _X (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)

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Devi Evaluation and Safety

510(k) K1101633

Page / of

(Updated February 3, 2005)

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.