Device Information
The LifeOutcomes C-Quest Blood Culture Sampling Device is a blood collection system designed to sequester the first portion of blood samples to reduce contamination in blood cultures. The device includes three main components: the tee body assembly, a universal culture tube holder, and a third-party FDA-cleared 5 ml diversion syringe.
Indications
This devicee collects patient blood samples and sequesters the initial portion to reduce contamination compared to standard blood culture methods.
Intended Use
The device is intended for medical professionals to reduce contamination in blood cultures. It can be used with a scalp vein set for venipuncture or via an IV using an extension set.
Availability
Prescription use only.
Study Results
- Nonclinical and Safety Testing: Testing included biocompatibility, sterilization validation, packaging integrity, and performance tests like actuation force and sequestration verification. The device passed all necessary standards, including ISO 10993-1 and IEC 62366.
Regulatory Information:
- Regulation Number: 21 CFR 862.1675
- Regulatory Class: Class II
- Product Code: JKA
- 510(k) Number: K231282
The device must comply with various regulations, including good manufacturing practices (21 CFR Part 820) and biological evaluation for material safety (ISO 10993-1).
Manufacturer Information:
- Name: LifeOutcomes LLC
- Address: 88 Inverness Circle East, Unit E-102, Englewood, CO 80112
- Contact Person: Robert J. McKinnon
Predicate Device Information
- Primary Predicate Device: Steripath Gen2 Blood Collection System (K192247)
- Differences: The predicate device allows for infusion, while C-Quest does not. Both devices sequester the initial blood sample to reduce contamination.
Implications
This device reduces contamination in blood cultures. Compared to predicate devices, it does not introduce significant changes and meets current regulatory standards.
References:
- LifeOutcomes C-Quest Blood Culture Sampling Device. K231282. LifeOutcomes LLC: FDA summary link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K231282
- Manufacturer website: https://www.lifeoutcomes.us
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