# K231282: LifeOutcomes C-Quest™ Blood Culture Sampling Device

- Pathway: 510(k) (Traditional)
- Applicant: Lifeoutcomes, LLC
- Decided: Jan 26, 2024 after 268 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K970259 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192247: Steripath Gen2 Blood Collection System, Magnolia Medical Technologies, Inc. (2020) Summary page 4.

## Indications for use
The LifeOutcomes C-Quest Blood Culture Sampling Device (C-Quest) is a 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.

Source page: https://510kreport.com/device/K231282
Methodology: https://510kreport.com/methodology