KET-1 Blood Ketone Monitoring System

K182593 · Apex BioTechnology Corp. · JIN · Dec 18, 2018 · Clinical Chemistry

Device Facts

• Record ID: K182593
• Device Name: KET-1 Blood Ketone Monitoring System
• Applicant: Apex BioTechnology Corp.
• Product Code: JIN · Clinical Chemistry
• Decision Date: Dec 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1435
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The KET-1 Blood Ketone Monitoring system is intended to quantitatively measure β-hydroxybutyrate (β-ketone) in fresh capillary whole blood from fingertips. It should only be used by a single patient and it should not be shared. Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes mellitus at home as an aid to monitoring the effectiveness of diabetes control programs. It is not to be used for diagnosis or screening of diabetes, or for neonatal use.

Device Story

KET-1 Blood Ketone Monitoring System measures β-hydroxybutyrate in fresh capillary whole blood; utilizes amperometric detection via test strips; enzyme β-hydroxybutyrate dehydrogenase converts β-hydroxybutyrate to acetoacetate; magnitude of electrical current proportional to ketone concentration; results displayed in mmol/L. Intended for home self-testing by patients with diabetes; single-patient use only. Provides quantitative data to assist patients in monitoring diabetes control programs. System includes KET-1 meter, test strips, and control solutions. Requires 0.8 μL blood sample; analysis time 8 seconds. Not for diagnosis or screening of diabetes.

Clinical Evidence

Lay-user accuracy study conducted with 100 participants comparing self-tested fingertip capillary blood results to laboratory reference (Beckman DxC 800). For concentrations < 1.5 mmol/L, 98% (92/94) were within ± 0.15 mmol/L and 100% within ± 0.30 mmol/L. For concentrations ≥ 1.5 mmol/L, 100% (6/6) were within ± 20%. Linear regression showed R² = 0.9837. Bench testing confirmed precision, linearity (0.1-8.0 mmol/L), interference resistance, and robustness across hematocrit (20-60%), altitude (up to 10,335 ft), and environmental conditions.

Technological Characteristics

Amperometric biosensor; enzyme-based (β-hydroxybutyrate dehydrogenase); 0.8 μL sample volume; 8-second analysis time; 2x CR2032 3V battery power; operating range 10-40°C, 20-90% RH; hematocrit range 20-60%. Single-patient use design; validated for 1825 cleaning/disinfection cycles with Clorox Healthcare Bleach Germicidal Wipes.

Indications for Use

Indicated for self-testing of β-hydroxybutyrate (β-ketone) in fresh capillary whole blood from fingertips by people with diabetes to monitor diabetes control programs. Not for diagnosis or screening of diabetes; not for neonatal use.

Regulatory Classification

Identification

A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.

Predicate Devices

• Nova Max Plus Blood Glucose and β-ketone Monitor System (k091547)

Submission Summary (Full Text)

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December 18, 2018

Apex Biotechnology Corp. Lisa Liu Manager of Quality Assurance Division No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu. 30078 Taiwan

Re: K182593

Trade/Device Name: KET-1 Blood Ketone Monitoring System Regulation Number: 21 CFR 862.1435 Regulation Name: Ketones (nonquantitative) test system Regulatory Class: Class I, meets the limitation of exemption 21 CFR 862.9(c)(5) Product Code: JIN Dated: September 13, 2018 Received: September 20, 2018

Dear Lisa Liu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Kellie B. k

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

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| Food and Drug Administration<br>ndications for Use | ee PPA Statement below<br>oiration Date: 06/30/2020 |
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| 510(k) Number (if known<br>K182593 | |
| KET-1 Blood Ketone Monitoring System<br>Device Name | |
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## 9 510(k) Summary

| 510(k) number | K182593 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Apex Biotechnology Corp. |
| | No. 7, Li-Hsin Road V, Hsinchu Science Park |
| | Hsinchu, 30078 |
| | CHINA (TAIWAN) |
| Contact Person: | Lisa Liu |
| | Manager of Quality Assurance Division |
| | Apex Biotechnology Corp. |
| | No. 7, Li-Hsin Road V, Hsinchu Science Park |
| | Hsinchu, 30078 |
| | CHINA (TAIWAN) |
| | email: [e-mail] |
| | Phone: [phone] |
| | FAX: [phone] |
| Date Prepared: | December 05, 2018 |
| Trade Names: | KET-1 Blood Ketone Monitoring System |
| Classification: | Ketones (nonquantitative) test system, 21 CFR 862.1435, Class I, meets |
| | limitation of exemptions 21 CFR 862.9(c)(5) |
| Product Codes: | JIN |
| Predicate Devices: | Nova Max Plus Blood Glucose and β-ketone Monitor System (k091547) |
| Device Description: | The KET-1 Blood Ketone Monitoring System consists of the KET-1 |
| | Blood Ketone Meter, KET-1 Blood Ketone Test Strips, and KET-1 |
| | Ketone Control Solutions (Level 1 and Level 2). The system is for |
| | self-testing of blood ketone. The KET-1 Blood Ketone Test Strips and |
| | KET-1 Ketone Control Solutions are purchased separately. |
| Intended Use: | KET-1 System: The KET-1 Blood Ketone Monitoring System is intended<br>to quantitatively measure $\beta$ -hydroxybutyrate ( $\beta$ -ketone) in fresh capillary<br>whole blood from fingertips. It should only be used by a single patient and it<br>should not be shared. Testing is done outside the body (In Vitro diagnostic<br>use). It is intended for self-testing by people with diabetes at home as an aid to<br>monitoring the effectiveness of diabetes control programs. It is not to be used<br>for diagnosis or screening of diabetes, or for neonatal use.<br>The KET-1 Blood Ketone Monitoring System is comprised of the KET-1<br>Blood Ketone Meter and KET-1 Blood Ketone Test Strip. |
| Comparison of<br>Technological<br>Characteristics: | The $\beta$ -ketone ( $\beta$ -Hydroxybutyrate) measurement is based on amperometric<br>biosensor technology using the enzyme $\beta$ -hydroxybutyrate dehydrogenase. The<br>enzyme reacts with $\beta$ -Hydroxybutyrate in blood and produces electrical current<br>that the magnitude of electrical current resulting from this enzymatic reaction is<br>proportional to the amount of $\beta$ -hydroxybutyrate. The meter measures the<br>electrical current and displays the concentration of $\beta$ -Hydroxybutyrate in blood.<br><br>The technological characteristics of KET-1 Blood Ketone Monitoring<br>System are substantially equivalent to the predicate system (k091547). |
| Non-Clinical<br>Testing: | Testing was conducted as follows: EMC and Electrical Safety, disinfection<br>performance (robustness of meter to multiple cleanings and disinfections),<br>software verification and validation, linearity testing with validation of Lo/Hi<br>detection, temperature and humidity testing, sample volume verification,<br>precision testing, repeatability testing, interferences testing, altitude testing,<br>qualification of control solutions, hematocrit performance testing, results<br>demonstrate substantial equivalence to the predicate system. |
| Clinical Testing | An accuracy study was conducted with home users using finger capillary<br>whole blood. Results demonstrate substantial equivalence to the predicate<br>system. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the KET-1 Blood Ketone<br>Monitoring Systems perform in a substantially equivalent manner to that of<br>the predicate. We conclude that the KET-1 Blood Ketone Monitoring<br>Systems is substantially equivalent to the predicate system |

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510(k) Summary (Continued)