# K053327: Oxicom Control

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Jan 26, 2006 after 56 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K880447 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921519: Oxicom-2100, Waters Instruments, Inc. (1992) Summary page 1.
- K974822: Avl Opti-Check PH/ Blood Gas/ Electrolyte/THB/ SO2 Control, Avl Scientific Corp. (1998) Summary page 1.
- K880447: Multi-Function Blood Gas Control, Bionostics, Inc. (1988) Summary page 1.

## Indications for use
Oxicom Control is intended to be used to monitor and evaluate the analytical performance of the Waters Oxicom models 2000, 2100 and 3000 oxygen saturation meters for the measurement of oxygen saturation. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The three levels of oxygen saturation provided by the controls allow performance monitoring within the clinically important range.

Source page: https://510kreport.com/device/K053327
Methodology: https://510kreport.com/methodology