FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM

K131013 · Nova Biomedical Corporation · NBW · Oct 17, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131013
• Device Name: FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Nova Biomedical Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FOCUS Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or forearm. Intended to be used by a single-patient and should not be shared. Intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. Alternative site testing on the forearm can be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates. FOCUS Blood Glucose Test Strips are used only with FOCUS Meters to quantitatively measure whole blood glucose in fresh, human capillary whole blood taken from the fingertip or forearm. FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and Test Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. The FOCUS PRO Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood obtained from the fingertip or forearm. Intended for testing outside the body (in vitro diagnostic use) for multi-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. Alternative site testing on the forearm should be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates. FOCUS PRO Blood Glucose Test Strips are used only with FOCUS PRO Meters for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood taken from the fingertip or forearm..

Device Story

Handheld blood glucose monitoring system; measures glucose in capillary, venous, or arterial whole blood via electrochemical sensing (GDH-FAD enzyme). User inserts test strip into meter; applies blood sample via capillary action; meter performs analysis in 4 seconds. Output displayed on LCD; results plasma-calibrated. FOCUS version for single-patient self-testing; FOCUS PRO version for multi-patient professional use. Meter stores up to 400 results; provides audible/visual alerts; includes ketone alert (>240 mg/dL). Powered by 3V lithium battery. Control solutions verify system performance; meter automatically detects control solution via impedance measurement and excludes results from patient averages. Benefits include rapid, quantitative glucose monitoring to aid diabetes control.

Clinical Evidence

Bench testing only. No new clinical performance studies were required for the modifications. Analytical performance (precision, linearity, specificity, hematocrit range, altitude, and sample volume) was established in previous submissions (k112638, k122435). Verification studies included a Glucose Control Auto Detection Study (n=360, 100% correct identification) and a Ketone Test Alert Study. Infection control robustness was validated for 10,950 cleaning/disinfection cycles.

Technological Characteristics

Electrochemical glucose sensor using GDH-FAD enzyme. Handheld meter powered by 3V CR2032 lithium battery. No-coding system. Measures glucose in 4 seconds using 0.4µL sample. Connectivity: standalone. Storage: 400 results. Features: test strip ejector, ketone alert, automatic control solution detection via impedance.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip/forearm) for single-patient self-testing (FOCUS) or venous/arterial/capillary whole blood for multi-patient professional use (FOCUS PRO) as an aid in diabetes control monitoring. Contraindicated for neonates, diabetes screening/diagnosis, and critically ill/shock/dehydrated/hyper-osmolar patients.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Nova One Glucose Monitor System (K122435)

Submission Summary (Full Text)

{0}------------------------------------------------

KI3JOB

## 510(k) Summary

:

:

.

.

:

| 510(K) Owner: | Nova Biomedical Corporation |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 200 Prospect St.<br>Waltham, MA 02454 |
| Phone: | 781-894-0800 |
| Fax Number: | 784-891-4806 |
| Registration<br>Number: | 1219029 |
| Contact Person: | Paul W. MacDonald |
| Date Prepared: | 01 April 2013 |
| Proprietary<br>Name: | FOCUS Blood Glucose Monitoring System<br>FOCUS Pro Blood Glucose Monitoring System |
| Common Or<br>Usual Name: | Glucose Test System (Glucose Meter, Test Strips, and Glucose Controls) |
| Classification<br>Name: | Glucose Dehydrogenase, Glucose |
| Device<br>Classification: | II |
| Regulation<br>Number: | 21 CFR § 862.1345 |
| Product Codes: | NBW, LFR, JJX |
| Predicate<br>Device(s): | K122435: Nova Biomedical Corporation Nova One Glucose Monitor System |
| Intended Use: | The FOCUS Blood Glucose Monitoring System is intended for the quantitative<br>measurement of glucose in fresh capillary whole blood obtained from the fingertip<br>or forearm. Intended to be used by a single patient and should not be shared.<br>Intended for self-testing outside the body by people with diabetes mellitus as an<br>aid to monitor the effectiveness of diabetes control. Alternative site testing on the<br>forearm can be used only during steady-state blood glucose conditions. Not<br>intended for the diagnosis of or screening for diabetes, and not intended for use<br>on neonates.<br><br>FOCUS Blood Glucose Test Strips are used only with FOCUS Meters to<br>quantitatively measure whole blood glucose in fresh, human capillary whole blood<br>taken from the fingertip or forearm.<br><br>FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and<br>Test Strips as a quality control check to verify that the meter and test strip are<br>working together properly, and that the test is performing correctly. |

OCT 17 2013:

{1}------------------------------------------------

The FOCUS PRO Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood obtained from the fingertip or forearm. Intended for testing outside the body (in vitro diagnostic use) for multipatient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with sing-use, auto-disabling lancing devices. Alternative site testing on the forearm should be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates.

FOCUS PRO Blood Glucose Test Strips are used only with FOCUS PRO Meters for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood taken from the fingertip or forearm.

FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and Test Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.

The FOCUS and FOCUS Pro Blood Glucose Monitoring Systems are comprised of glucose reagent test strips using glucose dehydrogenase flavin-adenine dinucleotide chemistry (GDH-FAD), a portable hand-held electronic meter and glucose control solutions.

The FOCUS and FOCUS Pro Blood Glucose Monitoring Systems are identical and include identical components (test strips, meter, control solutions), differing only in name to identify the intended user of the system. The FOCUS Blood Glucose Monitoring System is intended for single-patient use (self-testing) and the FOCUS Pro Blood Glucose Monitoring System is intended for multi-patient use (healthcare professional user).

When a user inserts a test strip into the meter, the meter turns on. While the test strip is in the meter, the user obtains a blood or glucose control sample, and then applies the sample to the test strip by touching the test strip to the sample. When an adequate amount of sample has been applied to the test strip, the meter emits an audible beep (when this feature is selected by the user) and the test begins. The meter's liquid crystal display (LCD) shows a test is in process by counting down from the number 4. When the test is complete, the meter displays the glucose result. Blood glucose results are plasma-calibrated to facilitate comparison to standard laboratory methods of blood glucose measurement.

The Blood Glucose Meter is a handheld device powered by one 3-volt nonrechargeable lithium battery. The meter includes a Test Port for insertion of a single test strip, an LCD display, a test strip release button, and buttons to navigate through menu choices. Meter operation is self-prompting using three user interface buttons. In addition to measuring glucose, the Meter also stores blood glucose and control solution results. The Meter offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts. A "battery low" warning alerts the user to change the batteries. Battery charge information is available on the "Meter status screen". The user can select the auto shutoff option to conserve power when the Meter is not in use. Test data and Meter setup information will be stored in a non-volatile form to prevent data loss.

Device Description:

{2}------------------------------------------------

Meter Power Supply: The meter uses single volt (3V) lithium, non rechargeable battery (# CR2032). Theoretical battery life is approximately 1 year or 1000 tests, when testing is performed three times per day.

No-Coding System. The user is not required to enter a test strip lot-specific Calibration Code into the meter by pressing a button or by inserting a Code Key. FOCUS and FOCUS Pro test strips are assigned only one code and this single code is used for all strip lots.

Glucose Control Solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other nonreactive ingredients (dye). They contain no products of human origin. There are three leveis of controls, (Levels 1, 2 and 3).

When a control solution sample is applied to the FOCUS or FOCUS Pro test strip, the meter automatically detects and identifies the glucose control sample using an impedance measurement while performing the glucose measurement. After identifying the sample as control solution, the meter marks the result with the control solution icon and stores the marked result in the meter memory. All control results are excluded from the glucose patient result average calculations.

Summary of the Technological Characteristics: The FOCUS and FOCUS Pro Blood Glucose Monitors have the same fundamental scientific technology and the same intended use as the predicate Nova One Glucose Monitor System (K122435).

The FOCUS and FOCUS Pro Blood Glucose Monitors measure glucose electrochemically as described in the Nova One Glucose Monitor System (K122435). In the same manner, the magnitude of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in whole blood and control solutions.

fundamental scientific technology and have the same intended use as the

The FOCUS and FOCUS Pro Biood Glucose Monitors use the same

predicate Nova One Glucose Monitor System (K122435).

Comparison to Predicate Devices:

Performance Studies:

The performance of the FOCUS and FOCUS Pro Blood Glucose Monitors was studied in the laboratory and in Human Factors testing by healthcare professionals and lay users. The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements.

Conclusion: Results of laboratory and Human Factors testing demonstrate that the performance of the FOCUS and FOCUS Pro Blood Glucose Monitors have the same intended uses, with similar technological characteristics and can produce results that are substantially equivalent to results obtained on the predicate devices. The systems perform as intended and raise no new safety or effectiveness issues.

{3}------------------------------------------------

liernation of the finances for ass on moonatoo.
Itemative site testing on the forearm should
e used only during steady-state blood
lucose conditions. 122435: Nova One System Professional Monitori edicate Device 20 - 600 oCUS PRO Blood Glucose Test Strips are
ed only with FOCUSS PRO Meters for Meters for Mare
antitative measurement of the Meters for Areast of Arman
nous and arterial whole blo FOCUS PRO Blood Glucose Monitori
System (Professional Monitoring) ng together properly, and that IS Control Solution is for use t
IS and FOCUS PRO Meter and Meter and the see a
that the meter and test strips ometric Electrochemical Senso is performing correc or foream 20 - 600 for FOCUS Blood Glucose Test Strips are used
only with FOCUS Meters to quantitatively
measure whole blood glucose in fresh, links
measure whole blood glucose in fresh many t intended for the diagnosis of or screening
diabetes, and not intended for use on OCUS Blood Glucose Monitoring System
Self-Monitoring) FOODS Biood Glucose Monitorias
Alam Andre Maniforne Monitorial Colliany
Palante Maniforne of Costa Marillany
Paraman Antalina County Collection Comments of Comments on Comme betes mellitus as an aid to more of a more home methor mess of energenerality and the mess of diveness of diveness of disable for and one on one of one of one of one of one o orking together properly, and that
st is performing correctly. CUS Control Solution is for uss
CUS and FOCUS PRO Meter Child Meter of Strips and For the Strips as a stription in the strip ulometric Electrochemical Sens or foream neonates 20 - 600 leasurement Range Operating Principl Jse/Intended Use HARACTERIST ndications for

ble 0-1: Comparison of Proposed Devices and Predicate devic

Page 4 of

{4}------------------------------------------------

| CHARACTERISTIC | FOCUS Blood Glucose Monitoring System<br>(Self-Monitoring) | FOCUS PRO Blood Glucose Monitoring<br>System (Professional Monitoring) | Predicate Device<br>K122435: Nova One System<br>(Professional Monitoring) |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Hematocrit Range (%) | 25 - 60 | 25 - 60 | 25 - 60 |
| Sample Type | Capillary whole blood from the fingertip, forearm | Venous, arterial whole blood and capillary<br>whole blood from the fingertip, forearm | Venous, arterial whole blood and capillary<br>whole blood from the fingertip, forearm |
| Sample Size | 0.4µL | 0.4µL | 0.4µL |
| Glucose Units | mg/dL | mg/dL | mg/dL |
| Sample Application | Capillary action of test strip | Capillary action of test strip | Capillary action of test strip |
| Handheld Meter | Yes | Yes | Yes |
| Meter Data Storage | Up to 400 blood and control solution results | Up to 400 blood and control solution results | Up to 400 blood and control solution results |
| Analysis Time<br>(seconds) | 4 | 4 | 4 |
| Insulin Tracking | No | No | No |
| Power Source | One 3-volt coin cell battery | One 3-volt coin cell battery | One 3-volt coin cell battery |
| Test Strip Ejector | Yes | Yes | Yes |
| Test Strip Active<br>Reagent (Enzyme) | Glucose Dehydrogenase - FAD | Glucose Dehydrogenase - FAD | Glucose Dehydrogenase - FAD |
| Test Strip Calibration<br>Coding | No coding. No user input of calibration code<br>required | No coding. No user input of calibration code<br>required | No coding. No user input of calibration code<br>required |
| Controls | Liquid, 3 levels | Liquid, 3 levels | Liquid, 3 levels |
| Automatic Control<br>Detection | Yes, identifies Control sample as Control. | Yes, identifies Control sample as Control | N/A |
| Lancing Device | Reusable lancing device and sterile lancets | Single use disposable safety lancets (not<br>supplied) | Nova single use disposable safety lancets |
| Ketone Alert | Yes, when glucose value is above 240 mg/dL.<br>Feature can be turned on/off by the user<br>during set up. | Yes, when glucose value is above 240 mg/dL.<br>Feature can be turned on/off by the user<br>during set up. | N/A |

.

Page 5 of 5

{5}------------------------------------------------

DEPARTMENT OF HEALTII & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 17, 2013

Nova Biomedical Corporation c/o Paul W. MacDonald, Ph.D. 200 Prospect St. WALTHAM MA 02454-9141

Re: K131013

Trade/Device Name: Focus Blood Glucose Monitoring System Focus Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: October 11, 2013 Received: October 15, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{6}------------------------------------------------

Page 2-Dr. MacDonald

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDcvices/Salcty/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 [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

## Indications for Use Form

510(k) Number (if known): K131013

FOCUS Blood Glucose Monitoring System Device Name:

Indications for Use:

The FOCUS Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or forearm. Intended to be used by a single patient and should not be shared. Intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. Aitemative site testing on the forearm can be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates.

FOCUS Blood Glucose Test Strips are used only with FOCUS Meters to quantitatively measure whole blood glucose in fresh, human capillary whole blood taken from the fingertip or forearm.

FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and Test Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.

Prescription Use

AND/OR

Over-The-Counter Use ×

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

## Stayce Beck

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) _

Page 1 of 1

{8}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K131013 FOCUS Pro Blood Glucose Monitoring System Device Name:

Indications for Use:

The FOCUS PRO Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood obtained from the fingertip or forearm. Intended for testing outside the body (in vitro diagnostic use) for multi-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with sing-use, auto-disabling lancing devices. Alternative site testing on the foream should be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates.

FOCUS PRO Blood Glucose Test Strips are used only with FOCUS PRO Meters for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood taken from the fingertip or forearm.

FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and Test Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.

Prescription Use ×

AND/OR

Over-The-Counter Use ×

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

## Stayce Beck

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) .

Page 1 of 1