# K972868: Trademark Blood Gas/Electrolyte/Glucose, Lactate, Bun and Creatinine Control

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Aug 28, 1997 after 24 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K012431: Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte Control, Levels 1,2,3 (2001), 0 descendants of its own

## Recalls of this device
- Jan 9, 2024 · Class II · Z-1315-2024: Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 
- Jan 9, 2024 · Class II · Z-1314-2024: Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 

## Indications for use
This material is intended for use to monitor the measurements of: a. pH and pCO2 and p02 in blood gas analyzers, b. Na, K, C1, Li, Cat+, and Mg++ in electrolyte analyzers, and; c. glucose, lactate, BUN and creatinine in analyzers which measure these metabolites. The Control is provided at three clinically significant levels to make possible verification of instrument performance at different points for each analyte. This product is for In Vitro Diagnostic Use only. Determination of acid-base status, and the concentrations of oxygen, carbon dioxide, electrolytes and certain critical metabolites in arterial blood is an important adjust to patient monitoring for a variety of clinical conditions. Since therapeutic regiments are often determined by the results obtained on patient samples, the instruments used to perform these measurements must meet stringent requirements for accuracy and precision. The use of this quality control material is to confirm the performance of instruments which measure critical blood analytes (i.e. electrolytes and critical metabolites) and blood gases and pH.

Source page: https://510kreport.com/device/K972868
Methodology: https://510kreport.com/methodology