510(k) · Cleared
ClearedLyphochek Elevated Immunosuppressant Control, Level 4, 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Oct 7, 2004 as substantially equivalent to K022041 (Bio-Rad Laboratories, Inc., 2002) after a 41-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Oct 7, 2004
- Review
- 41 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K895905 (1990). 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 deviceK042324 Lyphochek Elevated Immunosuppressant Control, Level 4, 5Bio-Rad · 2004
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) | K042324 | Lyphochek Elevated Immunosuppressant Control, Level 4, 5 | Bio-Rad | 2004 | — |
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? (1)
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 |
|---|---|---|---|
| * | K022041 | Lyphochek Whole Blood Control, Models 561, 562, 563Summary page 1…Which Substantial Equivalence is Claimed Lyphochek Whole Blood Control Bio-Rad Laboratories Irvine, California 510 (k) Number: K022041 4.0 Description of Device This product is prepared from human whole blood with added chemicals and pr… | 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 14 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K022041.
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?
Lyphochek Elevated Immunosuppressant Control is intended for use as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042324: Lyphochek Elevated Immunosuppressant Control, Level 4, 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042324
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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