The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by health care professionals for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. It is intended to provide plasma equivalent results to laboratory methods. The Nova StatStrip Lactate Hospital Meter System is indicated for use in a clinical setting by healthcare professionals as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis.

Nova StatStrip Lactate Test Strips are intended for use only with Nova StatStrip Lactate Hospital Meter for quantitative determination of lactate in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. The performance characteristics of the device for lactate measurements on capillary specimens have not been established. Nova StatStrip Lactate Test Strips are for testing outside the body (in vitro diagnostic use only).

Nova StatStrip Lactate Control Solutions are intended for use with the Nova StatStrip Family of Meters and Nova StatStrip Lactate Test Strips as a quality control check to verify the accuracy of blood lactate test results. There are 2 levels of controls. (Level 1 and Level 2).

Nova StatStrip Lactate Linearity Kit solutions are used to check the linearity of the Nova StatStrip Family of Meters. There are 4 levels of lactate linearity solutions: Level 1, Level 2, Level 3, and Level 4.

Device Description

The Nova StatStrip Lactate Hospital Meter System consists of:

Nova StatStrip Lactate Hospital Meter
Nova StatStrip Lactate Test Strips
Nova StatStrip Lactate Control Solutions (Levels 1 and 2)
Nova StatStrip Lactate Linearity Solutions (Levels 1,2,3 and 4)
Meter Docking Station

AI/ML Overview

The provided text does not contain specific acceptance criteria or detailed performance data from a study that would allow for a direct numerical comparison in a table. The document is a 510(k) summary and approval letter, stating that performance studies were conducted and the device was found substantially equivalent to predicate devices. However, it does not provide the raw performance data, acceptance thresholds, or detailed methodology of these studies.

Therefore, many of the requested fields cannot be filled with specific information from the provided document.

Here's an attempt to answer based on the available information, with clear indications where information is not provided:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Not explicitly stated numerically in document)	Reported Device Performance (Summary statement only, no specific values)
Accuracy (vs. predicate devices)	(Not explicitly stated numerically, implied to be "substantially equivalent")	"The studies demonstrated that the blood lactate results were substantially equivalent to the current methods for blood lactate measurements."
Equivalence (to laboratory methods)	(Not explicitly stated numerically)	"It is intended to provide plasma equivalent results to laboratory methods."
Precision/Reproducibility	(Not provided)	(Not provided)
Linearity	(Not provided, though linearity solutions are mentioned for checking)	(Not provided)
Interference	(Not provided)	(Not provided)
Measuring Range	(Not provided)	(Not provided)
Time to Result	(Not provided, though "within 13 seconds" is mentioned for both new and predicate device)	"Each utilizes a test strip that is inserted into a meter for results within 13 seconds."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not provided. The document mentions "Laboratory and clinical testing was performed" but does not specify the number of samples or patients included in these studies.
Data Provenance: Not provided specific details. The studies were described as "Laboratory and clinical testing," implying data collected for the purpose of this submission. The country of origin is not specified, but the submitter is a U.S. company. It's likely prospective data collected for the purpose of the 510(k) submission, given the nature of performance studies for new devices, but this is an inference.

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

Not provided. The document states "substantially equivalent to the current methods for blood lactate measurements" and "plasma equivalent results to laboratory methods," implying comparison to established methods or gold standards, but the process of establishing ground truth for the specific test set is not detailed.

4. Adjudication method for the test set

Not provided. Given that the ground truth establishment method is not described, the adjudication method is also not mentioned.

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 is a medical device for quantitative determination of lactate in whole blood, not an imaging or diagnostic AI device that involves human reader interpretation. Therefore, an MRMC study is not relevant to this type of device.

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

The device itself is a standalone system (meter and test strips) that provides a quantitative lactate reading. The performance studies described would inherently be standalone, assessing the device's ability to measure lactate accurately. There isn't a separate "algorithm only" component beyond the device's inherent operation.

7. The type of ground truth used

The ground truth would implicitly be reference laboratory methods for lactate measurement, as the device aims to provide "plasma equivalent results to laboratory methods" and demonstrate "substantial equivalence to the current methods for blood lactate measurements."

8. The sample size for the training set

Not applicable/Not provided. This device is a measurement system (meter and test strips), not a machine learning or AI-based diagnostic tool that typically involves a distinct "training set" for model development in the same way. Its performance is based on its electrochemical detection principle and manufacturing precision, not on being "trained" on a dataset. The performance studies mentioned are for validation or verification, not training.

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

Not applicable/Not provided, as there isn't a "training set" in the context of this type of device.

Summary

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510(k) Summary

K/00602

510(k) Summary

(as required by 21 CFR 807.92)

AUG 1 7 2011

Submitter: Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454 U.S.A.

Correspondent: Paul W. MacDonald Chief Quality Assurance and Regulatory Affairs Officer

Phone: 781-894-0800 ex 211; Fax: 781-891-4806 Email: pmacdonald@novabio.com

Device Name:

Nova StatStrip Lactate Hospital Meter System

Common Name:

Blood Lactate Test System

Classification:

Division of Clinical Laboratory Devices Clinical Chemistry Lactate dehydrogenase test system. Class II per 21 CFR 862.1440

Product Codes:

CFJ, KHP

Predicate Devices:

KDK Corporation Lactate Pro System, K980908 (handheld meter) Nova Biomedical StatProfile pHOx Plus L K023567, K012058 (analyzer)

Description of the Device:

The Nova StatStrip Lactate Hospital Meter System consists of:

1. Nova StatStrip Lactate Hospital Meter
1. Nova StatStrip Lactate Test Strips
1. Nova StatStrip Lactate Control Solutions (Levels 1 and 2)
1. Nova StatStrip Lactate Linearity Solutions (Levels 1,2,3 and 4)
1. Meter Docking Station

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Intended Use/Indications for Use:

Meter:

Test Strips:

Control Solutions:

Summary of Technological Characteristics:

The Nova StatStrip Lactate Hospital Meter System has similar fundamental scientific technology and a similar intended use as the currently marketed Lactate Pro System (K980908).

Both the Lactate Pro and the proposed Nova StatStrip Lactate Hospital Meter System are hand held devices with similar intended use to quantitatively measure the lactate levels in whole blood. The principle of operation is the same for the proposed and predicate device. Each utilizes a test strip that is inserted into a meter for results within 13 seconds.

Comparison to Predicate Devices:

The proposed Nova StatStrip Lactate Hospital Meter System uses the same fundamental scientific technology, similar specifications, and has a similar intended use as the predicate Lactate Pro System (K980908). In addition, the proposed Nova StatStrip Lactate Hospital Meter System can produce equivalent results to the previously cleared Nova Biomedical StatProfile pHOx Plus L (K023567, K012058), which is a tabletop multianalyte chemistry analyzer,

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Performance Studies:

Laboratory and clinical testing was performed on the proposed Nova StatStrip Lactate Hospital Meter System. The studies demonstrated that the blood lactate results were substantially equivalent to the current methods for blood lactate measurements.

Conclusion:

Results of laboratory and clinical testing demonstrate that the performance of the Nova StatStrip Lactate Hospital Meter System has the same intended uses, with similar technological characteristics and can produce results that are substantially equivalent to results obtained on the predicate devices. The system performs as intended and raises no new safety or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping shapes representing the head, body, and legs.

Re:

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Nova Biomedical Corporation c/o Mr. Paul W. MacDonald Chief Quality Assurance/Regulatory Affairs Officer 200 Prospect Street Waltham, MA 02454-9141

AUG 1 7 2011

K100602 Trade/Device Name: Nova StatStrip Lactate Hospital Meter System. Regulation Number: 21 CFR 862.1450 Regulation Name: Lactic acid test system. Regulatory Class: Class 1, meets limitations of exemptions per 21 CFR 862.9(c)(9) Product Code: KHP, JJX Dated: August 15, 2011 Received: August 16, 2011

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 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

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

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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510(k) Number:

K100602

Device Name:

Nova StatStrip Lactate Hospital Meter System

Indications for Use:

Meter:

The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals for multiple patient use in a professional healthcare setting for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis. It is not for use on capliary blood specimens. It is intended to provide plasma equivalent results to laboratory methods.

Test Strips:

Nova StatStrip Lactate Test Strips are intended for use only with the Nova StatStrip Lactate Hospital Meter for quantitative determination of lactate in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. The performance characteristics of the device for lactate measurements on capillary specimens have not been established. Nova StatStrip Lactate Test Strips are for testing outside the body (in vitro diagnostic use only).

Control Solutions:

Nova StatStrip Lactate Control Sclutions are intended for use with the Nova StatStrip Lactate Hospital Meter and Nova StatStrip Lactate Test Strips as a quality control check to verify the accuracy of blood lactate test results. There are 2 levels of controls, (Levels 1 and Level 2).

Nova StatStrip Lactate Linearity Kit solutions are used to check the linearity of the Nova StatStrip Lactate Hospital Meter. There are 4 levels of lactate linearity solutions: Level 1, Level 3, and Level 4.

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)

Initial Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Onice Oraluation and Safety

510(k) L4100602

(Updated February 3, 2005)

Page ( of .

Regulation Number and Section

§ 862.1450 Lactic acid test system.

(a)
Identification. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.