Search Results
Found 1 results
510(k) Data Aggregation
K Number
K231282Device Name
LifeOutcomes C-Quest Blood Culture Sampling Device
Manufacturer
Date Cleared
2024-01-26
(268 days)
Product Code
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
LifeOutcomes LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LifeOutcomes C-Quest Blood Culture Sampling Device intended to collect a patient blood sample and sequester the first portion of the sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. It is used in conjunction with either a scalp vein set for venipuncture or access to an existing patient IV using an extension set. C-Quest may be used with a blood culture tube or a standard blood collection syringe.
Device Description
The LifeOutcomes LLC (LO) C-Quest™ Blood Culture Sampling Device (C-Quest) is a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample. This reduces the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. C-Quest is intended for use by medical professionals. The C-Quest consists of three (3) major components: • the tee body assembly. • a universal culture tube holder, and - a third-party, FDA cleared, 5 ml diversion syringe.
Ask a Question
Ask a specific question about this device
Page 1 of 1