(89 days)
KET-1 System: The KET-1 Blood Ketone Monitoring System is intended to quantitatively measure $\beta$ -hydroxybutyrate ( $\beta$ -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 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. The KET-1 Blood Ketone Monitoring System is comprised of the KET-1 Blood Ketone Meter and KET-1 Blood Ketone Test Strip.
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.
This document describes the regulatory approval of the KET-1 Blood Ketone Monitoring System. The provided text is a 510(k) summary, which outlines the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics. Instead, it describes general categories of testing and concludes that the device demonstrates substantial equivalence. For quantitative tests like accuracy, it states that "results demonstrate substantial equivalence to the predicate system" without providing specific numbers or ranges for the acceptance criteria.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions an "accuracy study" conducted with "home users using finger capillary whole blood." However, it does not specify the sample size (number of participants or samples) used for this accuracy study or any other mentioned tests (e.g., precision, repeatability, linearity).
- Data Provenance: The device manufacturer is Apex Biotechnology Corp. located in Hsinchu, Taiwan. The location of the clinical study (accuracy study) is not explicitly stated, but it is reasonable to infer it would be in Taiwan or a region where the manufacturer operates or has a testing facility. The data provenance is retrospective in the sense that the studies were completed before the 510(k) submission for regulatory review. However, the accuracy study itself was likely conducted prospectively (data collected specifically for the study) from the home users.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a blood ketone monitoring system, ground truth would typically be established by a reference laboratory method (e.g., gas chromatography-mass spectrometry or a highly accurate clinical chemistry analyzer) rather than expert human interpretation of images. The document does not specify details of the ground truth method or the personnel involved.
4. Adjudication method for the test set
This information is not applicable in the context of a blood ketone monitoring system, as it measures a quantitative analyte. Adjudication methods (e.g., 2+1, 3+1) are typically used for qualitative or diagnostic imaging studies where human experts interpret results and disagreements need to be resolved. For a quantitative measurement, the "ground truth" (reference method result) is directly compared to the device's measurement.
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
An MRMC study is not applicable to this device. This type of study is relevant for AI-powered diagnostic imaging devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The KET-1 Blood Ketone Monitoring System is a quantitative point-of-care device that measures a chemical analyte and does not involve human interpretation of complex images or AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The KET-1 Blood Ketone Monitoring System is a standalone device in the sense that it provides a direct quantitative measurement of β-ketone. Its "performance" is its accuracy and precision in measuring blood ketone levels compared to a reference method, rather than a diagnostic algorithm that processes complex data for human review. The documented testing (accuracy, precision, linearity) essentially assesses the standalone performance of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for the accuracy study was established by a reference method, as is standard for quantitative diagnostic devices. While not explicitly stated, clinical chemistry analyzers or other highly accurate laboratory methods would be used to obtain the "true" β-ketone values against which the KET-1 system's results are compared. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
The document does not provide any information about a training set. This is likely because the KET-1 Blood Ketone Monitoring System is a pre-calibrated electrochemical device, not an AI/machine learning model that typically requires a large training dataset. The "training" of such a device usually refers to the internal calibration and manufacturing processes, not the statistical training of a data-driven model.
9. How the ground truth for the training set was established
As there is no mention of a training set in the context of an AI/ML model, the establishment of ground truth for a training set is not applicable or described. The device's calibration and internal algorithms would be developed and validated through rigorous engineering and internal testing, using precisely known, manufactured control solutions and spiked samples, rather than a labeled training dataset in the AI sense.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Administrationndications for Use | ee PPA Statement belowoiration Date: 06/30/2020 |
|---|---|
| 510(k) Number (if knownK182593 | |
| KET-1 Blood Ketone Monitoring SystemDevice 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: lisaliu@apexbio.com | |
| Phone: 011-886-3-5641952 | |
| FAX: 011-886-3-5678021 | |
| 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 intendedto quantitatively measure $\beta$ -hydroxybutyrate ( $\beta$ -ketone) in fresh capillarywhole blood from fingertips. It should only be used by a single patient and itshould not be shared. Testing is done outside the body (In Vitro diagnosticuse). It is intended for self-testing by people with diabetes at home as an aid tomonitoring the effectiveness of diabetes control programs. It is not to be usedfor diagnosis or screening of diabetes, or for neonatal use.The KET-1 Blood Ketone Monitoring System is comprised of the KET-1Blood Ketone Meter and KET-1 Blood Ketone Test Strip. |
| Comparison ofTechnologicalCharacteristics: | The $\beta$ -ketone ( $\beta$ -Hydroxybutyrate) measurement is based on amperometricbiosensor technology using the enzyme $\beta$ -hydroxybutyrate dehydrogenase. Theenzyme reacts with $\beta$ -Hydroxybutyrate in blood and produces electrical currentthat the magnitude of electrical current resulting from this enzymatic reaction isproportional to the amount of $\beta$ -hydroxybutyrate. The meter measures theelectrical current and displays the concentration of $\beta$ -Hydroxybutyrate in blood.The technological characteristics of KET-1 Blood Ketone MonitoringSystem are substantially equivalent to the predicate system (K091547). |
| Non-ClinicalTesting: | Testing was conducted as follows: EMC and Electrical Safety, disinfectionperformance (robustness of meter to multiple cleanings and disinfections),software verification and validation, linearity testing with validation of Lo/Hidetection, temperature and humidity testing, sample volume verification,precision testing, repeatability testing, interferences testing, altitude testing,qualification of control solutions, hematocrit performance testing, resultsdemonstrate substantial equivalence to the predicate system. |
| Clinical Testing | An accuracy study was conducted with home users using finger capillarywhole blood. Results demonstrate substantial equivalence to the predicatesystem. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the KET-1 Blood KetoneMonitoring Systems perform in a substantially equivalent manner to that ofthe predicate. We conclude that the KET-1 Blood Ketone MonitoringSystems is substantially equivalent to the predicate system |
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510(k) Summary (Continued)
§ 862.1435 Ketones (nonquantitative) test system.
(a)
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.(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.