# K980178: Oxyhemoglobin Control for CO-Oximetry

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Feb 12, 1998 after 23 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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: 1 generation back to K832066 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832066: Control 282, Bio-Nustics, Inc. (1983) Summary page 1.
- K861901: Multi-4 CO-Oximeter Control, Allied Instrumentation Laboratory (1986) Summary page 1.

## Indications for use
The measurement of the concentrations of total hemoglobin, oxyhemoglobin, carboxyhemoglobin, and methemoglobin can serve to monitor tissue oxygenation and therefore the various metabolic factors which effect oxygen transport of blood. Since therapeutic regimes are often determined by the result obtained in patient samples, the instruments used for these analyses must meet clinical requirements for precision and accuracy. The use of control materials are designed to verify test results and assist in identifying instrument calibration or operating problems.

Source page: https://510kreport.com/device/K980178
Methodology: https://510kreport.com/methodology