510(k) · Cleared
ClearedMicrogenics Cyclosporine Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · LAS Drug Specific Control Materials
Cleared on Oct 17, 2003 as substantially equivalent to K030616 (Microgenics Corp., 2003) and 1 other predicate after a 36-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Oct 17, 2003
- Review
- 36 days
- Class
- Class I
- Product code
- LAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K895905 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK895905 Lyphochek Whole Blood Control (Human) Levels 1,2,3Bio-Rad · 1990
- 2 generations backK980871 Lyphochek Whole Blood ControlBio-Rad · 1998
- 1 generation backK022041 Lyphochek Whole Blood Control, Models 561, 562, 563Bio-Rad Laboratories, Inc. · 2002
- This deviceK032842 Microgenics Cyclosporine Control KitMicrogenics Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895905 | Lyphochek Whole Blood Control (Human) Levels 1,2,3 | Bio-Rad | 1990 | — |
| −2 | K980871 | Lyphochek Whole Blood Control | Bio-Rad | 1998 | — |
| −1 | K022041 | Lyphochek Whole Blood Control, Models 561, 562, 563 | Bio-Rad Laboratories, Inc. | 2002 | — |
| 0 (this device) | K032842 | Microgenics Cyclosporine Control Kit | Microgenics Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K030616 | Cedia Cyclosporine Plus High Range Controls 4 and 5Summary page 1…cology control material Product Code: LAS Regulatory Class: Class I Predicate Devices: CEDIA@Cyclosporine Plus High Range Controls 4 and 5 (K030616) Lyphochek@Whole Blood Control (KO2204 1) manufactured by Bio-Rad Laboratories. Device Description: The Microgenics Cyclosporin… | 2003 |
| * | K022041 | Lyphochek Whole Blood Control, Models 561, 562, 563Summary page 2…Predicate Device Predicated Device Characteristics ~ (K030616) (K022041) Intended Use Microgenics Cyclospor- CEDIA@' Cyclosporine Lyphochek@'Whole ine… | 2002 |
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 13 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All LAS devicesLAS Drug Specific Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032842 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032842: Microgenics Cyclosporine Control Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032842
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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