NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS by NOVA BIOMEDICAL CORP.

The Nova StatSensor Creatinine Hospital Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.

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

Nova StatSensor Creatinine Control Solutions are intended for use with the Nova StatSensor Creatinine Hospital Meter and Nova StatSensor Creatinine Test Strips as a quality control check to verify the accuracy of blood creatinine 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 StatSensor Creatinine Linearity Kit solutions are used to check the linearity of the Nova StatSensor Creatinine Hospital Meter System. There are five levels of Linearity Solutions, (Level 1, Level 2, Level 3, Level 4, and Level 5).

Device Description

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AI/ML Overview

Here's the analysis of the provided text regarding the Nova StatSensor Creatinine Hospital Meter, focusing on acceptance criteria and study details.

Important Note: The provided document is an FDA 510(k) clearance letter and an Indications for Use statement. It does not contain the detailed study write-up that would typically include acceptance criteria and specific performance data. Therefore, I can only extract information that is explicitly stated or can be reasonably inferred from this type of regulatory document. Many of the requested details (sample sizes, expert qualifications, adjudication methods, MRMC studies, training set details) are not present in this document.

Acceptance Criteria and Device Performance Study Analysis

Based on the provided documents (FDA 510(k) clearance letter K070068 and Indications for Use), the Nova StatSensor Creatinine Hospital Meter is cleared for marketing as it has been deemed "substantially equivalent" to legally marketed predicate devices. This indicates that the device met the performance requirements necessary to demonstrate this substantial equivalence. However, the exact numerical acceptance criteria and the detailed study design proving those criteria are not present in these documents.

Missing Information: A typical detailed study report would include specific numerical targets for accuracy, precision, linearity, etc., and the results obtained against those targets. This document only confirms that such testing must have occurred to achieve 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (from predicate/general regulatory standards)	Reported Device Performance (as inferred from 510(k) clearance)
Accuracy / Bias	Must be demonstrably equivalent to a legally marketed predicate device for creatinine measurement in whole blood.	Deemed substantially equivalent to predicate devices; performs with acceptable accuracy for its intended use (quantitative measurement of creatinine in capillary, venous, and arterial whole blood, providing plasma equivalent results).
Precision	Must be within acceptable limits for a quantitative creatinine assay.	Achieved sufficient precision to demonstrate substantial equivalence.
Linearity	Must demonstrate linearity across the stated measurement range.	Linearity kit solutions are available, implying successful linearity testing across 5 levels.
Interfering Substances	(Not specified in document, but generally required) Minimal interference from common endogenous and exogenous substances.	Implied to be acceptable based on 510(k) clearance.
Reproducibility	(Not specified in document, but generally required) Consistent results across different operators, lots, and instruments.	Implied to be acceptable based on 510(k) clearance.
Calibrated to Plasma Equivalency	Must provide plasma equivalent results.	Explicitly stated: "The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods."

(Note: The "Acceptance Criteria" column is inferred from the general requirements for 510(k) cleared IVD devices and the nature of the predicate determination. The "Reported Device Performance" column states what the FDA's clearance implies, rather than specific numerical outcomes, as these are not provided.)

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

Sample Size (Test Set): Not specified in the provided documents.
Data Provenance: Not specified in the provided documents (e.g., country of origin, retrospective or prospective). Safety and effectiveness data, likely gathered prospectively from clinical or laboratory studies in the US or other regions, would have been submitted to the FDA as part of the 510(k) application.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
- For an in vitro diagnostic device measuring a chemical analyte like creatinine, the "ground truth" would typically be established by a reference method run by trained laboratory personnel in a CLIA-certified or equivalent laboratory, not necessarily "experts" in the sense of clinicians reviewing images, but rather highly skilled laboratory technicians and clinical chemists.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. This is generally not applicable in the same way for quantitative chemical assays as it would be for subjective interpretations (e.g., radiology reads). The "ground truth" for a chemical assay is typically a quantitative result from a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC study is not applicable for this type of device. MRMC studies are used for devices that assist human interpretation of diagnostic images (e.g., radiologists interpreting X-rays or MRI scans). The Nova StatSensor Creatinine Hospital Meter is a quantitative assay device; it measures a biochemical marker directly, rather than assisting human readers in interpreting complex data.
Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed or is relevant for this device type.

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

Standalone Performance Study: Yes, the performance testing for an in vitro diagnostic device like this is inherently "standalone" in the sense that the device measures creatinine directly without human interpretive intervention. The performance characteristics (accuracy, precision, linearity, etc.) are evaluated based on the device's output compared to a reference method. There isn't an "algorithm" in the same sense as an AI image interpretation tool, but rather the electrochemical detection and calculation within the meter.

7. The Type of Ground Truth Used

Ground Truth Type:
- Reference laboratory method: For quantitative diagnostic devices like this, the ground truth is established by a highly accurate and precise reference method for creatinine measurement (e.g., enzymatic or HPLC-based methods) performed in a clinical laboratory.
- The document states, "The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods," indicating that established laboratory methods serve as the standard for comparison.

8. The Sample Size for the Training Set

Sample Size (Training Set): Not specified in the provided documents.
- For a chemical assay device, "training set" doesn't apply in the same way as for machine learning algorithms. Instead, there would be internal development and verification studies using various samples to optimize the assay chemistry, electrode design, and instrument calibration before formal validation studies. The number of samples used in these internal studies is generally proprietary and not disclosed in regulatory summaries.

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

Ground Truth for Training Set: Not specified.
- Similar to the test set, during the development and calibration phases, the ground truth would have been established using reference laboratory methods for creatinine measurement on various samples to guide the optimization and calibration of the Nova StatSensor system.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three human figures below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Nova Biomedical Corp. c/o Dr. Paul W. MacDonald Chief Quality and Regulatory Affairs Officer 200 Prospect Street Waltham, MA 02454-9141

MAY - 7 2007

Re: K070068

Trade/Device Name: Nova Statsensor Creatinine Hospital Meter, Nova Statsenor Creatinine Quality Control Levels 1,2,3, Nova Statsensor Creatinine Linearity Solutions Levels 1,2,3,4.5 Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system. Regulatory Class: Class II Product Code: CGL, JJX Dated: March 19, 2007 Received: March 20, 2007

Dear Dr. 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 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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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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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 (if known): K070068

Device Name:_____Nova StatSensor Creatinine Hospital Meter

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Office of In Vitro Diagnostic Device
Evaluation and Safety

Regulation Number and Section

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.