Finetest Lite Smart Blood Glucose Monitoring System

K201396 · Osang Healthcare Co. , Ltd. · NBW · Oct 16, 2020 · Clinical Chemistry

Device Facts

• Record ID: K201396
• Device Name: Finetest Lite Smart Blood Glucose Monitoring System
• Applicant: Osang Healthcare Co. , Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 16, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Finetest lite Smart Blood Glucose Monitoring System is comprised of the 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 fingertins, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

Device Story

System measures glucose concentration in fresh capillary whole blood; utilizes electrochemical sensing via test strips. Meter receives electrical current generated by glucose reaction on strip; converts current to quantitative glucose value. Used at home by patients with diabetes for self-monitoring of glycemic control. Output displayed on meter screen; informs patient of current glucose level to aid diabetes management. System includes meter, test strips, control solution, and lancing device. Device is a modified version of predicate with changes limited to meter appearance.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed performance, functionality, and reliability against pre-determined pass/fail criteria. Disinfection study validated CaviWipes (EPA 46781-8) for effective inactivation of live virus on the meter surface.

Technological Characteristics

Electrochemical glucose measurement system. Components: meter, test strips, control solution, lancing device. Meter utilizes electrical current sensing principle. Disinfection validated for CaviWipes. No specific materials or software architecture details provided beyond standard blood glucose monitoring system functionality.

Indications for Use

Indicated for single-patient use for the quantitative measurement of glucose in capillary whole blood from the fingertip, palm, or forearm as an aid in monitoring the effectiveness of diabetes control programs.

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

• Oh'Care Lite Smart Blood Glucose Monitoring System (K182286)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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.

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="checked" type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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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 : [phone] Fax : [phone]

## 2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Irvine, CA 92620 Phone: [phone] Fax: [phone] Email: [e-mail]

## 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:

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.

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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.