On Call Express Voice Blood Glucose Monitoring System

K191038 · ACON Laboratories, Inc. · NBW · Jun 12, 2019 · Clinical Chemistry

Device Facts

• Record ID: K191038
• Device Name: On Call Express Voice Blood Glucose Monitoring System
• Applicant: ACON Laboratories, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 12, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The On Call® Express Voice Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steadystate times (when blood glucose level is not changing rapidly). The On Call® Express Voice Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only. The On Call® Express Voice Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

Device Story

On Call Express Voice Blood Glucose Monitoring System; quantitative glucose measurement in capillary whole blood; utilizes test strips and meter; intended for home use by patients with diabetes; provides audible voice output for results; aids in monitoring diabetes control programs; alternative site testing permitted during steady-state glucose levels; single-patient use; not for neonates.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison to the predicate device.

Technological Characteristics

Electrochemical glucose biosensor. Power: two 1.5V AAA batteries. Memory: 500 records. Dimensions: 3.94" x 2.39" x 0.94". Weight: 90g. Features: voice output (English/Spanish), volume control, expanded hematocrit range (25-60%).

Indications for Use

Indicated for single patient home use for the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, and forearm. Intended for use by people with diabetes to monitor glucose levels.

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

• On Call Express Blood Glucose Monitoring System (K133635)

Submission Summary (Full Text)

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K191038

B Applicant

ACON Laboratories, Inc.

C Proprietary and Established Names

On Call Express Voice 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. ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM (K132086)
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).

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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

- Addition of an optional voice feature that communicates results to the user in English and Spanish.
- The claimed hematocrit range has expanded from 30-55% to 25-60%.
- The meter size has changed from 3.46" x 1.93" x 0.65" to 3.94" x 2.39" x 0.94" and the meter weight (with batteries) has changed from 50 grams to 90 grams.
- The display size has increased from 1.38" x 1.26" to 1.54" x 1.67" and a volume control icon was added to the meter display.
- The battery was changed from one (1) CR 2032 3.0V coin cell battery to two (2) AAA 1.5V batteries.
- Change in name from On Call® Express Glucose Monitoring System to On Call® Express Voice Glucose Monitoring System.
- The memory has increased from 300 records with time and date to 500 records with time and date.

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

4. 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 On Call Express Voice Blood Glucose Monitoring System is intended for single patient home use. Disinfection efficacy studies were performed on the external materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, DisCide Ultra Disinfecting Towelettes (EPA Registration number: 10492-4). The sponsor also conducted robustness studies and demonstrated that there was no change in performance or in the external materials of the meter after 260 cleaning and disinfection cycles representing 5 years of single patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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