510(k) · Cleared
ClearedLyphochek Whole Blood Control, Models 561, 562, 563
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jul 16, 2002 as substantially equivalent to K980871 (Bio-Rad, 1998) after a 22-day review. Its family tree reaches back 2 generations to 1990. 6 later devices descend from it.
- Decided
- Jul 16, 2002
- Review
- 22 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895905 (1990). 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK895905 Lyphochek Whole Blood Control (Human) Levels 1,2,3Bio-Rad · 1990
- 1 generation backK980871 Lyphochek Whole Blood ControlBio-Rad · 1998
- This deviceK022041 Lyphochek Whole Blood Control, Models 561, 562, 563Bio-Rad Laboratories, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK072721 Lyphochek Whole Blood Immunosuppressant Control , Abbott…Bio-Rad, Diagnostics Grp. · 2007
- Descendant · 2 generations on · 0 of its ownK132174 Multichem WBTTechno-Path Manufacturing, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK080459 Chromesytems Toxicology Calibrators and ControlsChromsystems Instruments & Chemicals GmbH · 2009
- Descendant · cites it directly · 0 of its ownK051074 Mas Immunosuppressant ControlsMicrogenics Corp. · 2005
- Descendant · cites it directly · 0 of its ownK042324 Lyphochek Elevated Immunosuppressant Control, Level 4, 5Bio-Rad · 2004
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K072721Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCCBio-Rad, Diagnostics Grp. · 2007 · cites it directly2descendants
- K132174Multichem WBTTechno-Path Manufacturing, Ltd. · 2013 · 2 generations on0descendants
- K080459Chromesytems Toxicology Calibrators and ControlsChromsystems Instruments & Chemicals GmbH · 2009 · 2 generations on0descendants
- K051074Mas Immunosuppressant ControlsMicrogenics Corp. · 2005 · cites it directly0descendants
- K042324Lyphochek Elevated Immunosuppressant Control, Level 4, 5Bio-Rad · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895905 | Lyphochek Whole Blood Control (Human) Levels 1,2,3 | Bio-Rad | 1990 | — |
| −1 | K980871 | Lyphochek Whole Blood Control | Bio-Rad | 1998 | — |
| 0 (this device) | 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 | — |
| +2 | K132174 | Multichem WBT | Techno-Path Manufacturing, Ltd. | 2013 | — |
| +2 | K080459 | Chromesytems Toxicology Calibrators and Controls | Chromsystems Instruments & Chemicals GmbH | 2009 | — |
| +1 | K051074 | Mas Immunosuppressant Controls | Microgenics Corp. | 2005 | — |
| +1 | K042324 | Lyphochek Elevated Immunosuppressant Control, Level 4, 5 | Bio-Rad | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K980871 | Lyphochek Whole Blood ControlSummary page 1…e to Which Substantial Equivalence is Claimed Lyphochek@Whole Blood Control Bio-Rad Laboratories Irvine, California Docket Number: K980871 4.0 Description of Device Lyphochek@Whole Blood Control is prepared from human whole blood, with pure che… | 1998 |
What descends from it? (6)
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072721 (Bio-Rad, Diagnostics Grp., 2007) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K980871.
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?
LyphochekQ Whole Blood Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022041: Lyphochek Whole Blood Control, Models 561, 562, 563.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022041
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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