# K974822: Avl Opti-Check PH/ Blood Gas/ Electrolyte/THB/ SO2 Control

- Pathway: 510(k) (Traditional)
- Applicant: Avl Scientific Corp.
- Decided: Jan 22, 1998 after 29 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 K880447 (1988). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880447: Multi-Function Blood Gas Control, Bionostics, Inc. (1988) Summary page 1.
- K911755: Control for PH,Blood Gases,Eletrolytes,Glucose, Bionostics, Inc. (1991) Summary page 1.

## Most influential descendants
- K053327: Oxicom Control (2006), 0 descendants of its own

## Indications for use
AVL OPTI-check assayed control is intended to be used to monitor the measurement of pH, PCOz, POz, sodium, potassium, total hemoglobin content and oxygen saturation in the AVL OPTI Critical Care Analyzer, as well as other devices measuring the same parameters and ionized calcium and chloride. The determination of acid-base status, and concentration of carbon dioxide, oxygen, electrolytes, total hemoglobin and oxygen saturation is an important adjunct to patient monitoring for a variety of clinical conditions described in the labeling for those devices used for these purposes. Since therapeutic regimes are often determined by the results obtained in patient samples, the instruments used for these analyses must meet stringent requirements for accuracy and precision of measurement. It should be the goal of the quality control program in institutions performing these analyses to determine the instrumentation is working properly before the analysis and report of patient specimens, or after any suspicious results have been obtained.

Source page: https://510kreport.com/device/K974822
Methodology: https://510kreport.com/methodology