510(k) · Cleared
ClearedChromesytems Toxicology Calibrators and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chromsystems Instruments & Chemicals GmbH · LAS Drug Specific Control Materials
Cleared on Nov 17, 2009 as substantially equivalent to K072721 (Bio-Rad, Diagnostics Grp., 2007) and 1 other predicate after a 636-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Nov 17, 2009
- Review
- 636 days
- Class
- Class I
- Product code
- LAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K895905 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK895905 Lyphochek Whole Blood Control (Human) Levels 1,2,3Bio-Rad · 1990
- 3 generations backK980871 Lyphochek Whole Blood ControlBio-Rad · 1998
- 2 generations backK022041 Lyphochek Whole Blood Control, Models 561, 562, 563Bio-Rad Laboratories, Inc. · 2002
- 1 generation backK072721 Lyphochek Whole Blood Immunosuppressant Control , Abbott…Bio-Rad, Diagnostics Grp. · 2007
- This deviceK080459 Chromesytems Toxicology Calibrators and ControlsChromsystems Instruments & Chemicals GmbH · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895905 | Lyphochek Whole Blood Control (Human) Levels 1,2,3 | Bio-Rad | 1990 | — |
| −3 | K980871 | Lyphochek Whole Blood Control | Bio-Rad | 1998 | — |
| −2 | K022041 | Lyphochek Whole Blood Control, Models 561, 562, 563 | Bio-Rad Laboratories, Inc. | 2002 | — |
| −1 | K072721 | Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC | Bio-Rad, Diagnostics Grp. | 2007 | — |
| 0 (this device) | K080459 | Chromesytems Toxicology Calibrators and Controls | Chromsystems Instruments & Chemicals GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 LAS? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072721 | Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCCSummary page 1…ology) 21 CFR 862.3280 Common/Usual names: Immunosuppressants Control Material Predicate Devices: Bio-Rad Laboratories Lyphochek Whole Blood Immunosuppressant Control (K07272 1) Waters MassTrakTM Immunosuppressants Kit (K063868) K080459… | 2007 |
| * | K063868 | Masstrak Immunosuppressants KitSummary page 1…ppressants Control Material Predicate Devices: Bio-Rad Laboratories Lyphochek Whole Blood Immunosuppressant Control (K07272 1) Waters MassTrakTM Immunosuppressants Kit (K063868) K080459 11/02/09 Device De… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K072721.
How does its category compare?
All LAS devicesLAS Drug Specific Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LAS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LAS
Too few LAS 510(k)s in any year since 2007 to give a median.
Recalls per year · LAS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LAS
No MAUDE report names LAS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Chromsystems MassCheck Immunosuppressant Whole Blood Controls are in vitro
diagnostic devices intended to verify performance of various laboratory assay systems that
measure cyclosporine, tacrolimus, or sirolimus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080459 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080459: Chromesytems Toxicology Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080459
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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