The Finetest Lite Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Finetest Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Finetest Lite Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The Finetest Lite Smart Blood Glucose Test Strips are for use with the Finetest Lite Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be fingertins, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

Device Description

The Finetest Lite Smart Blood Glucose Monitoring System consists of a meter, test strips, control solution and a lancing device. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Finetest Lite Smart Blood Glucose Monitoring System" (K201396). This document is a regulatory approval, not a detailed study report. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance or AI algorithm validation is not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device (Oh'Care Lite Smart Blood Glucose Monitoring System, K182286). It states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not provide the specifics of these tests, such as the exact acceptance criteria for accuracy, precision, or the methodology of the studies.

Specifically, the document does not include information on:

A table of acceptance criteria and reported device performance (in the sense of clinical accuracy metrics).
Sample sizes used for test sets (other than implicitly, e.g., for disinfection study, but not for glucose measurement accuracy).
Data provenance (country of origin, retrospective/prospective) for clinical performance tests.
Number of experts, their qualifications, or adjudication methods for ground truth establishment.
Whether an MRMC study was done, or related effect sizes.
Standalone algorithm performance.
Type of ground truth (e.g., expert consensus, pathology, outcomes data).
Training set sample size or ground truth establishment for training, as this is a medical device approval, not an AI algorithm approval for which such data would be relevant.

The only specific "study" mentioned is a "Disinfection Study":
"Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of live virus of use with the meter." This is a validation for cleaning and disinfection, not for glucose measurement accuracy.

Therefore, I cannot fulfill most of your request based on the provided text. The document is a regulatory letter and a 510(k) summary, which typically summarizes the information provided to the FDA for a substantial equivalence determination rather than detailing all the underlying study results.

Summary of what can be extracted from the text (and what is missing):

Acceptance Criteria & Reported Performance:
- Acceptance Criteria for Disinfection: "complete inactivation of live virus" (implicitly, when CaviWipes are used).
- Reported Performance for Disinfection: "demonstrating complete inactivation of live virus".
- Acceptance Criteria for General Performance: "based on pre-determined Pass/Fail criteria" (details not provided).
- Reported Performance for General Performance: "The device passed all of the tests" (details not provided).
- Specific performance metrics for glucose measurement (e.g., accuracy, precision as per ISO 15197 guidelines often used for blood glucose meters) are NOT detailed in this summary.
Sample size for the test set and data provenance: Not specified for glucose accuracy tests. A "Disinfection Study" is mentioned, but its sample size is not quantified.
Number of experts and qualifications for ground truth: Not applicable/not provided for this type of device and submission summary.
Adjudication method for the test set: Not applicable/not provided.
MRMC comparative effectiveness study: Not mentioned/not applicable for this device type (not an AI-assisted diagnostic imaging task).
Standalone (algorithm only) performance: Not mentioned/not applicable.
Type of ground truth: Not specified (presumed to be laboratory reference methods for glucose measurement, but not stated).
Sample size for the training set: Not applicable (this device is not an AI algorithm that requires a "training set" in the machine learning sense).
How the ground truth for the training set was established: Not applicable.

Summary

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October 16, 2020

OSANG Healthcare Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA. Inc. 1150 Roosevelt STE 200 Irvine, CA 92620

Re: K201396

Trade/Device Name: Finetest Lite Smart Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: October 16, 2020 Received: September 16, 2020

Dear Priscilla Chung:

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.

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

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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 postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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. Kelm, Ph.D. Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201396

Device Name

Finetest Lite Smart Blood Glucose Monitoring System

Indications for Use (Describe)

The Finetest lite Smart Blood Glucose Monitoring System is comprised of the Smart meter and the Finetest Lite Smart Blood Glucose Test Strips.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (K201396)

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 10/16/2020

Applicant / Submitter: 1.

OSANG Healthcare Co., Ltd. 132, Anyangcheondong-Ro Dongan-Gu Anyang, Gyeonggido, 14040, Republic of Korea Tel : +82-31-460-0415 Fax : +82-31-460-0401

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Irvine, CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device:

Trade Name: Finetest Lite Smart Blood Glucose Monitoring System
· Classification Name: Blood Glucose Test System
Classification regulation: 21 CFR Part 862.1345
" Product Code: NBW

4. Predicate Device:

Oh'Care Lite Smart Blood Glucose Monitoring System (K182286) by OSANG Healthcare Co., Ltd.

5. Description:

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6. Indications for use:

The Finetest lite Smart Blood Glucose Monitoring System is comprised of the Finetest Lite Smart meter and the Finetest Lite Smart Blood Glucose Test Strips.

The Finetest Lite Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh, The Finetest Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Finetest Lite Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Finetest Lite Smart Blood Glucose Test Strips are for use with the Finetest Lite Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

7. Comparison to the Cleared Device

The modifications are changes in the meter appearance. Other than these modifications, the modified meter is identical to the predicate device in terms of indications for use, technological characteristics, and specifications.

8. Performance Data

Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.

Disinfection Study: Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of live virus of use with the meter.

9. Conclusion

The conclusion drawn from the verification/validation activities is that the subject devices is substantially equivalent to the predicated device.

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.