Device Information
Device Specifications: The Facet Aurora Reusable Lancet Base is a reusable, spring-loaded device designed to quickly eject and retract a lancet to obtain a small blood sample for diagnostic purposes. It has been used in the U.S. for over ten years with no significant design changes. It has adjustable depth settings from 0.5 mm to 2.75 mm.
Indications
The device is intended to obtain capillary blood for diagnostic testing in children, adolescents, and adults in home settings. It is reusable and can be cleaned and disinfected between uses.
Intended Use
The device is designed for patients of all ages (children, adolescents, and adults) in home settings. It provides an easy-to-use method for obtaining capillary blood.
Availability
The device is available for over-the-counter use as per 21 CFR 801 Subpart C.
Study Results
- Nonclinical and Safety Testing: The device underwent extensive bench testing, including depth adjustment, durability, and biocompatibility assessments. Mechanical tests showed that it can endure a 1-meter drop and simulated 3 years of use.
Regulatory Information
- Regulation Number: 21 CFR 878.4850
- Regulatory Class: Class II
- Product Code: QRL
- 510(k) Number: K232912
The device must comply with additional regulations, including 21 CFR Parts 800 to 898 and other specific FDA standards for lancing devices.
Manufacturer Information
- Name: Facet Technologies, LLC
- Address: 3900 North Commerce Drive, Atlanta, GA 30344
- Contact Person: James Bonds, Director of Regulatory Affairs
Predicate Device Information
- Primary Predicate Device: Facet Aurora Reusable Lancet Base (510(k) exempt)
- Differences: The current device is substantially equivalent to the predicate device, with no major technological or functional changes.
Implications
The device offers a reusable method for blood sampling in home settings. It helps in managing conditions that require regular blood glucose monitoring.
References
- Facet Aurora Reusable Lancet Base. 510(k) Number K232912. Facet Technologies, LLC: FDA Summary Link. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K232912
- https://www.facetmed.com.
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