# K913133: Chality Control Material (Assayed & Unassayed)

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Sep 27, 1991 after 73 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K032453: Roche Combitrol and Autotrol Plus B Multi Analyte Control (2003), 4 descendants of its own
- K152553: CueSee Hypoxic (2016), 0 descendants of its own
- K131595: Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVM (2013), 0 descendants of its own
- K121468: Eurotrol Gas-Ise Metabolites (2012), 0 descendants of its own
- K111188: Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus B (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K913133
Methodology: https://510kreport.com/methodology