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

Indications for 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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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K201396

B Applicant

OSANG Healthcare Co., Ltd.

C Proprietary and Established Names

Finetest Lite Smart Blood Glucose Monitoring System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBW | Class II | 21 CFR 862.1345 - Glucose Test System | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. The Oh'Care Lite Smart Blood Glucose Monitoring System (K182286).
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:

- Change in color and texture of exterior meter housing materials and change in shape of the meter buttons.
- Dimensions of the meter were changed from 83 x 56 x 18 ±1 (mm) to 81 x 52 x 16±1 (mm).
- The meter weight with batteries changed from 43±1 g to 46±1 g.
- The meter memory capacity was changed from 365 test results to 500 test results.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

The device system is intended for single-patient use only. Disinfection efficacy studies were previously performed on the exterior meter materials (k103021) by an outside testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant CaviWipes Disinfecting Towelettes (EPA Registration 46781-8). A robustness study was performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 1,095 cleaning and disinfection cycles with the CaviWipes Disinfecting Towelettes. The robustness studies were designed to simulate 3 years of single patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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