# K032453: Roche Combitrol and Autotrol Plus B Multi Analyte Control

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Aug 28, 2003 after 17 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 K913133 (1991). 1 ancestor in all.
4 later devices descend from it; 4 cite 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)
- K913133: Chality Control Material (Assayed & Unassayed), Bionostics, Inc. (1991)

## Cited in the summary but kept off the family tree
- K910127: Sunglasses, Non-Prescription (Polinelli), The Limited Stores, Inc. (1991). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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

## Indications for use
COMBITROL PLUS B / AUTOTROL PLUS B assayed controls are intended to be used to monitor and evaluate the analytical performance of the Roche OMNI S for analytes listed in the package insert.

Source page: https://510kreport.com/device/K032453
Methodology: https://510kreport.com/methodology