On Call Pro Blood Glucose Monitoring System

K161867 · Acon Laboratories · NBW · Aug 5, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161867
• Device Name: On Call Pro Blood Glucose Monitoring System
• Applicant: Acon Laboratories
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 5, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device system is intended for multiple-patient use.

Device Story

On Call Pro Blood Glucose Monitoring System; quantitative measurement of glucose in capillary whole blood. Input: fresh capillary blood sample via test strip. Operation: electrochemical biosensor technology; meter measures electrical current generated by glucose reaction on strip; converts current to glucose concentration. Output: digital glucose reading on meter display. Usage: clinical settings; operated by healthcare professionals. Benefit: aids monitoring of diabetes control programs. Requires single-use, auto-disabling lancing devices for infection control in multi-patient environments.

Clinical Evidence

No clinical data provided in the document. Substantial equivalence established via bench testing and performance evaluation of the glucose monitoring system.

Technological Characteristics

Glucose monitoring system consisting of meter and lancing device. Materials validated for robustness against PDI Super Sani Cloth Germicidal Disposable Wipes (EPA Reg. no. 9480-4). No changes to fundamental scientific technology, sensing principle, or energy source.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip, forearm, palm) by healthcare professionals in clinical settings to monitor diabetes control. Contraindicated for neonates and for diabetes diagnosis or screening. AST restricted to steady-state glucose conditions.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k161867

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)

On Call Pro Blood Glucose Monitoring System (k151595)

2. Submitter'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 addition of a validated cleaning and disinfection procedure for the use of an additional disinfectant, PDI Super Sani Cloth Germicidal Disposable Wipes (EPA Reg. no. 9480-4) to the labeling of On Call Pro 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 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 multiple-patient use. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, PDI Super Sani Cloth Germicidal Disposable Wipes (EPA Reg. no. 9480-4). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter and lancing device after 10950 cycles of cleaning and disinfection with the PDI Super Sani Cloth Germicidal Disposable Wipes. The robustness studies were designed to simulate 3 years of multiple-

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patient use (10 cleaning and disinfection cycles per day). Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.