Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System

K182046 · Tyson Bioresearch, Inc. · NBW · Nov 30, 2018 · Clinical Chemistry

Device Facts

• Record ID: K182046
• Device Name: Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System
• Applicant: Tyson Bioresearch, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 30, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Tyson Bio HS100-B Blood Glucose Monitoring System and Tyson Bio HS100 Blood Glucose Monitoring System are intended for single patient home use.

Device Story

The Tyson Bio HS100/HS100-B are blood glucose monitoring systems for home use by patients with diabetes. The system consists of a handheld meter, test strips, and control solutions. It uses electrochemical biosensor technology with glucose dehydrogenase to measure glucose in capillary whole blood. The patient applies a blood sample to the test strip; the meter performs amperometric detection and displays the glucose concentration. The HS100-B model includes Bluetooth connectivity, while the HS100 does not. The device aids patients in monitoring diabetes control effectiveness. It is intended for single-patient use; results are used by the patient to manage their condition.

Clinical Evidence

No clinical data provided. The submission relies on the substantial equivalence of the core technology (test strips and control solutions) to the previously cleared predicate (k170079).

Technological Characteristics

Electrochemical biosensor using glucose dehydrogenase (FAD); amperometric detection. Measuring range: 20-600 mg/dL. Hematocrit range: 10%-65%. Sample volume: 0.7 uL. Operating temperature: 10-40 °C. Humidity: 10-90%. Memory: 500 results. HS100-B includes Bluetooth; HS100 does not. Auto-coding test strips.

Indications for Use

Indicated for single patient home use for blood glucose monitoring.

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

• Tysons Bio HT100 Blood Glucose Monitoring System (K170079)
• Tyson Bio HT100-B Blood Glucose Monitoring System (K170079)

Submission Summary (Full Text)

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SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: k182046

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device: Tysons Bio HT100 Blood Glucose Monitoring System and Tyson Bio HT100-B Blood Glucose Monitoring System (k170079)

2. Applicant’s statement that the INDICATION/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 demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

The following modifications were made to the Tyson Bio HT100-B Blood Glucose Monitoring System:

- Change in meter size from 106 x 66x 20 mm (LWH) to 108 x 55 x 15mm (LWH).
- Change in meter color from pale grey to bright white
- Removal of USB transfer function
- Removal of Bluetooth function
- Change of test strip ejection button color from white to orange
- Moved the test strip ejection button from lower half to upper half of meter
- Change in operation button size
- Repositioning of icons on the user interface
- Change of name from Tyson Bio HT100-B Blood Glucose Monitoring System to Tyson Bio HS100-B Blood Glucose Monitoring System

The following modifications were made to the Tyson Bio HT100 Blood Glucose Monitoring System:

- Change in meter appearance
- Removal of USB transfer function
- Change of test strip ejection button color from white to orange
- Moved the test strip ejection button from lower half to upper half of meter
- Change in operation button size change

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- Repositioning of icons on the user interface.
- Change of name from Tyson Bio HT100 Blood Glucose Monitoring System to Tyson Bio HS100 Blood Glucose monitoring system

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, physical characteristics, and specifications.

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 applicant’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 applicant 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.

Tyson Bio HS100-B Blood Glucose Monitoring System and Tyson Bio HS100 Blood Glucose Monitoring System are intended for single patient home use. Disinfection efficacy studies were performed on the materials comprising the meter shell ejection button, LCD cover, and meter housing front and back with results demonstrating complete inactivation of hepatitis B Virus (HBV) with Clorox Germicidal Wipe (EPA Reg. No: 67619-12). The sponsor also conducted robustness studies and demonstrated that there was no change in performance or in the external materials of the meter after 550 cleaning and disinfection cycles representing 5 years of single patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures and found to be acceptable.

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