510(k) · Cleared
ClearedRoche Combitrol and Autotrol Plus B Multi Analyte Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionostics, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Aug 28, 2003 as substantially equivalent to K913133 (Bionostics, Inc., 1991) after a 17-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- Aug 28, 2003
- Review
- 17 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913133 (1991). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK913133 Chality Control Material (Assayed & Unassayed)Bionostics, Inc. · 1991
- This deviceK032453 Roche Combitrol and Autotrol Plus B Multi Analyte ControlBionostics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK152553 CueSee HypoxicEurotrol B.V. · 2016
- Descendant · cites it directly · 0 of its ownK131595 Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVMEurotrol B.V. · 2013
- Descendant · cites it directly · 0 of its ownK121468 Eurotrol Gas-Ise MetabolitesEurotrol B.V. · 2012
- Descendant · cites it directly · 0 of its ownK111188 Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B…Roche Diagnostics · 2012 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K152553CueSee HypoxicEurotrol B.V. · 2016 · cites it directly0descendants
- K131595Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVMEurotrol B.V. · 2013 · cites it directly0descendants
- K121468Eurotrol Gas-Ise MetabolitesEurotrol B.V. · 2012 · cites it directly0descendants
- K111188Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack…Roche Diagnostics · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913133 | Chality Control Material (Assayed & Unassayed) | Bionostics, Inc. | 1991 | — |
| 0 (this device) | K032453 | Roche Combitrol and Autotrol Plus B Multi Analyte Control | Bionostics, Inc. | 2003 | — |
| +1 | K152553 | CueSee Hypoxic | Eurotrol B.V. | 2016 | — |
| +1 | K131595 | Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVM | Eurotrol B.V. | 2013 | — |
| +1 | K121468 | Eurotrol Gas-Ise Metabolites | Eurotrol B.V. | 2012 | — |
| +1 | K111188 | Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc… | Roche Diagnostics | 2012 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K152553 (Eurotrol B.V., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032453 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032453: Roche Combitrol and Autotrol Plus B Multi Analyte Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032453
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026