# K012431: Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte Control, Levels 1,2,3

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Aug 28, 2001 after 28 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 K972868 (1997). 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)
- K972868: Trademark Blood Gas/Electrolyte/Glucose, Lactate, Bun and Creatinine Control, Bionostics, Inc. (1997) Summary page 1.
- K001632: Opti-Check Plus Multi-Analyte Control, Model HC7009, Avl Scientific Corp. (2000) Summary page 1.

## Indications for use
As a part of the quality control program in institutions reporting those analytes listed in the package insert, COMBITROL TS and AUTOTROL TS Multi-Analyte Controls should be used in Roche OMNI, alpha series instruments to evaluate test precision and to detect systematic analytical deviations in those laboratories choosing to use a traditional, liquid, quality control product.

Source page: https://510kreport.com/device/K012431
Methodology: https://510kreport.com/methodology