Mission Lipid Panel Monitoring System

K180504 · ACON Laboratories, Inc. · CHH · Mar 28, 2018 · Clinical Chemistry

Device Facts

• Record ID: K180504
• Device Name: Mission Lipid Panel Monitoring System
• Applicant: ACON Laboratories, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Mar 28, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Indications for Use

The device system is intended for multiple-patient use.

Device Story

Mission Lipid Panel Monitoring System is a point-of-care diagnostic device for professional healthcare use. It utilizes a meter, test cartridges, optical verifier, and control solution to analyze human capillary or venous whole blood samples. The system performs quantitative measurements of Total Cholesterol, HDL Cholesterol, and Triglycerides. It also calculates an estimated LDL Cholesterol value when Triglycerides are ≤400 mg/dL. Healthcare providers operate the device to assist in the diagnosis and management of lipid metabolism disorders, diabetes, and related conditions. The system requires the use of single-use, auto-disabling lancing devices for patient safety. Results are displayed to the clinician to inform clinical decision-making regarding patient treatment and monitoring.

Clinical Evidence

Bench testing only. Disinfection efficacy studies demonstrated complete inactivation of HBV using PDI Super Sani Cloth Germicidal Disposable Wipes. Robustness studies confirmed no degradation in performance or external materials after 10,950 cleaning/disinfection cycles, simulating 3 years of multiple-patient use.

Technological Characteristics

System includes a meter, test cartridges, optical verifier, and control solution. Operates via quantitative in vitro diagnostic analysis of whole blood. Designed for multiple patient use in professional settings. Requires single-use, auto-disabling lancing devices.

Indications for Use

Indicated for use as a cholesterol monitoring system for multiple-patient use in clinical settings.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Submission Summary (Full Text)

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SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: k180504

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. (For a preamendments device, a statement to this effect has been provided.)

Mission Cholesterol Pro Monitoring System, k163406

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 a new recommended disinfecting wipe, a change to the material of a button and a change of the name of the device from “Mission Cholesterol Pro Monitoring System” to “Mission Lipid Panel Monitoring System”.

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

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The device system is intended for multiple-patient use. Disinfection efficacy studies were performed on the materials comprising the meter 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 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 patient use (10 cleaning and disinfection cycles per day). Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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