NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM

K112955 · Nova Biomedical Corporation · KHP · Jan 5, 2012 · Clinical Chemistry

Device Facts

• Record ID: K112955
• Device Name: NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
• Applicant: Nova Biomedical Corporation
• Product Code: KHP · Clinical Chemistry
• Decision Date: Jan 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1450
• Device Class: Class 1

Intended Use

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 capillary blood specimens. It is intended to provide plasma equivalent results to laboratory methods. 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). Nova StatStrip Lactate Control Solutions are intended for use only 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 two levels of controls (Level 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 2, Level 3, and Level 4.

Device Story

Handheld lactate monitor; uses electromechanical biosensor with lactate oxidase (LOD) enzyme; accepts 0.6 uL fresh venous or arterial whole blood sample via test strip; provides quantitative lactate results in 13 seconds. Used by healthcare professionals in professional healthcare settings for point-of-care testing. Meter features automatic calibration; stores 1000 patient tests, 200 QC tests, and 4000 operator IDs. Output used by clinicians to assess patient acid-base status and identify lactic acidosis. Benefits include rapid, plasma-equivalent lactate measurement at the point of care, facilitating timely clinical decision-making.

Clinical Evidence

Bench testing only. Linearity study (n=9 concentrations, 0.2-21 mM) and method comparison (n=105 whole blood specimens) performed against Nova Stat Profile CCX Analyzer. Regression analysis showed high correlation (R2 > 0.99) across the 0.3-20 mmol/L range. No clinical studies conducted.

Technological Characteristics

Handheld electromechanical biosensor; utilizes lactate oxidase (LOD) enzyme; measuring range 0.3-20.0 mmol/L; sample size 0.6 uL; test time 13 seconds; automatic calibration; data storage for 1000 patient tests, 200 QC tests, and 4000 operators; weight 360 grams.

Indications for Use

Indicated for healthcare professionals in professional settings to quantitatively measure lactate in fresh venous and arterial whole blood to evaluate acid-base status in patients suspected of lactic acidosis. Not for use on capillary blood or neonates. Not for use with patients suspected of having sepsis.

Regulatory Classification

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).

Predicate Devices

• Nova StatStrip Lactate Hospital Meter System (k100602)

Submission Summary (Full Text)

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K112955

*nova*
biomedical

JAN - 5 2012

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# 510(k) Summary

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| 510(K) Owner: | Nova Biomedical Corporation |
|-----------------------|--------------------------------------------------------|
| Registration Number: | 1219029 |
| Address: | 200 Prospect St.<br>Waltham, MA 02454 USA |
| Phone: | 781-894-0800 |
| Fax Number: | 784-891-4806 |
| Contact Person: | Paul W. MacDonald |
| Date Prepared: | 30 Sept 2011 |
| Proprietary Name: | Nova StatStrip Lactate Hospital Meter System |
| Common Or Usual Name: | Lactate Monitor |
| Classification Name: | System, Test, Lactate |
| Product Codes: | KHP, JJX |
| Predicate Device: | K100602 - Nova StatStrip Lactate Hospital Meter System |
| Device Description: | Nova StatStrip Lactate Hospital Meter System |

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Nova Biornedical, 200 Prospect Street, Waltham, MA 02454-9141 U.S.A. Tel: [phone] www.novabiomedical.com

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| Intended Use: | Indications for Use:<br>The Nova StatStrip Lactate Hospital Meter System is intended for in vitro<br>diagnostic use by healthcare professionals for multiple patient use in a<br>professional healthcare setting for clinical and for point-of-care usage for<br>the quantitative determination of Lactate (Lac) in fresh venous and arterial<br>whole blood specimens as an aid to evaluate the acid-base status of<br>patients suspected of having lactic acidosis. It is not for use on capillary<br>blood specimens. It Is intended to provide plasma equivalent results to<br>laboratory methods. |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Technological<br>Characteristics: | The Nova StatStrip Lactate Hospital Meter System has the same<br>fundamental scientific technology and intended use as the currently<br>marketed Nova StatStrip Lactate Hospital Meter System (K100602).<br>Both the Nova StatStrip Lactate Hospital Meter System and the proposed<br>Nova StatStrip Lactate Hospital Meter System are hand held devices with<br>similar intended use to quantitatively measure the lactate levels in whole<br>blood. The principle of operation is the same for the proposed and<br>predicate device. Each utilizes a test strip that is inserted into a meter for<br>results within 13 seconds. |
| Comparison to<br>Predicate<br>Devices: | The proposed Nova StatStrip Lactate Hospital Meter System uses the same<br>fundamental scientific technology, similar specifications, and has the same<br>intended use as the predicate Nova StatStrip Lactate Hospital Meter<br>System (K100602). |
| Performance<br>Studies: | Laboratory testing was performed on the proposed Nova StatStrip Lactate<br>Hospital Meter System. The laboratory studies demonstrated that the blood<br>lactate results from the Nova StatStrip Lactate Hospital Meter System were<br>substantially equivalent to the current methods for blood lactate<br>measurements. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that the performance<br>of the Nova StatStrip Lactate Hospital Meter System has the same intended<br>uses, with similar technological characteristics and can produce results that<br>are substantially equivalent to results obtained on the predicate device. The<br>system performs as intended and raises no new safety or effectiveness<br>issues. |

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| Characteristic | Predicate | Proposed |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| | K100602 - Nova StatStrip Lactate<br>Hospital Meter System | Nova StatStrip Lactate<br>Hospital Meter System |
| Measuring Range | 0.7 - 20.0 mmol/L | 0.3 - 20.0 mmol/L |
| Operating Principle | Electromechanical Biosensor<br>Lactate oxidase (LOD) | Same |
| Intended Use | Indications for Use:<br>The Nova StatStrip Lactate Hospital<br>Meter System is intended for in<br>vitro diagnostic use by healthcare<br>professionals for multiple patient<br>use in a professional healthcare<br>setting for clinical and for point-of-<br>care usage for the quantitative<br>determination of Lactate (Lac) in<br>fresh venous and arterial whole<br>blood specimens as an aid to<br>evaluate the acid-base status of<br>patients suspected of having lactic<br>acidosis. It is not for use on<br>capillary blood specimens. It is<br>intended to provide plasma<br>equivalent results to laboratory<br>methods. | Same |
| Sample type | Whole Blood | Same |
| Sample size | 0.6 uL | Same |
| Sample application | Capillary Draw | Same |
| Handheld meter? | Yes | Same |
| Meter Calibration | Automatic | Same |
| Data storage | 1000 Patient Tests<br>200 QC Tests<br>4000 Operators | Same |
| Test Time | 13 Seconds | Same |
| Weight | 360 grams | Same |

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# Comparison of Predicate Devices and Proposed device

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Nova Biomedical Corporation c/o Paul W. MacDonald Chief Quality & Regulatory Affairs Officer 200 Prospect St. Waltham, MA 02454, USA

JAN - 5 2012

Re: k112955 Trade/Device Name: Nova StatStrip Lactate Hospital Meter System Regulation Number: 21 CFR 862.1450 Regulation Names: Lactic Acid Test System Regulatory Class: Class I, meets limitations of exemptions per 21 CFR 862.9 (c)(9) Product Code: KHP, JJX Dated: December 7, 2011 Received: December 9, 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 class II (Special Controls), 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); 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). 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.

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If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 [phone]. 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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

z

Courtney H. Lias, 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 (if known):

K112955

Device Name:

Nova StatStrip Lactate Hospital Meter System

Indications for Use:

### Meter.

Meter:
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arterial whole blood specimens as an aid to eveluse the acid-base status of provide arterial whole blood specimens as an all to eveluate the account of particle provide
of having lactic acidosis. It is not for use on capillary blood specimens. It is intended of naving lable doldes ults to laboratory methods.

### Test Strips:

Test Strips:
Nova StatStrip Lactate Test Strips are intended for use only with the Nova StatStrip Lactate Nova StatStrip Lactate Test Strips are intended to fresh venous and edited.
Hospital Meter for quantitative determination of lacted in fresh venous and the Hospital Meter for quantitative determination of actions. The performance characteristics of the
specimens. It is not for use on capillary blood specimens. The performance of specimens. It is not for use on capillary specimens. The portugios in the market in the material.
device for lact the one for tapillary specimens have not been other device for lactate measurements on capillary specifically outside the body in vitro diagnostic use only).

## Control and Linearity Solutions:

Control and Lineanty Solutions are intended for use with the Nova Stats of Lactate Nova Statstrip Lactate Control Solutions are intended in the resident Hospital Meter and Nova Statstip Laciate Test Sunps as a quality of and Level 2).
accuracy of blood lactate test results. There are 2 levels of check the Nova Sta accuracy of blood lactate test necused to check the lines the linearthy of the Nova StatStrip
Nova StatStrip Lactate Linearity Kit solutions an used the linearthy solutions: Nova StatStrip Lactate Linearly Kit solutions are used to check to check of the really of the really of the really a and Level 4.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(Part 21 CFR 601 Subpair D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (O(VD)

Signature

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

510(k) K112955

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