On Call Express II Blood Glucose Monitoring System

K192175 · ACON Laboratories, Inc. · NBW · Oct 17, 2019 · Clinical Chemistry

Device Facts

• Record ID: K192175
• Device Name: On Call Express II Blood Glucose Monitoring System
• Applicant: ACON Laboratories, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 17, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The On Call® Express II 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 steady-state times (when blood glucose level is not changing rapidly). The On Call® Express II 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 II Blood Glucose Monitoring System is not intended for the diamosis of or diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call® Express II Blood Glucose meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

Device Story

System measures glucose in fresh capillary whole blood; utilizes electrochemical biosensor technology; intended for single-patient home use. User applies blood sample to test strip inserted into meter; meter performs electrochemical analysis; displays glucose concentration on screen. Device features 500-record memory; powered by two CR2032 3.0V batteries. Designed for patient self-monitoring of blood glucose levels to assist in diabetes management. Meter housing is textured white plastic; dimensions 81.5 mm x 48.3 mm x 16 mm; weight 47.4 g. Validated for 260 cleaning/disinfection cycles using DisCide Ultra Towelettes to ensure material integrity and viral inactivation.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing.

Technological Characteristics

Electrochemical glucose test system. Meter housing: textured white plastic. Dimensions: 81.5 mm x 48.3 mm x 16 mm. Weight: 47.4 g. Power: 2x CR2032 3.0V batteries. Memory: 500 records. Hematocrit range: 25-60%.

Indications for Use

Indicated for single-patient home use for the quantitative measurement of glucose in fresh capillary whole blood samples.

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 (K132086)

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

K192175

B Applicant

ACON Laboratories, Inc.

C Proprietary and Established Names

On Call Express II 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).

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:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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- The claimed hematocrit range has expanded from 30-55% to 25-60%.
- The meter housing material surface texture and color changed from smooth coating to textured and from black to white, respectively.
- The meter size has decreased from 85 mm x 49 mm x 16.4 mm to 81.5 mm x 48.3 mm x 16 mm and the meter weight has changed from 50 g to 47.4 g (with batteries).
- The meter has an increased memory from 300 records to 500 records with time and date.
- The number of batteries has changed from 1 CR20323.OV coin cell battery to 2 CR20323.OV batteries.
- Change in name from On Call® Express Blood Glucose Monitoring System to the On Call Express II Blood Glucose Monitoring System.

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 II Blood Glucose Monitoring System is intended for single-patient home use only. Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of viral hepatitis B virus (HBV) with the chosen disinfectant, DisCide Ultra Disinfecting Towelettes (EPA Reg. No: 10492-4). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 260 cleaning and disinfection cycles designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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