510(k) · Cleared
ClearedLyphochek Immunoassay Plus Control
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 May 12, 1998 as substantially equivalent to K891475 (Bio-Rad, 1989) after a 13-day review. Its family tree reaches back 1 generation to 1989. 12 later devices descend from it.
- Decided
- May 12, 1998
- Review
- 13 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891475 (1989). 12 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK891475 Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3Bio-Rad · 1989
- This deviceK981532 Lyphochek Immunoassay Plus ControlBio-Rad · 1998
- Descendant · cites it directly · 5 of its ownK043108 Liquichek Specialty Immunoassay ControlBio-Rad Laboratories, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK110641 Fujirebio Diagnostics Vitamin D ControlFujirebio Diagnostics,Inc. · 2011
- Descendant · cites it directly · 1 of its ownK984594 Lyphochek Maternal Serum Control, Model 220Bio-Rad · 1999
- Descendant · 2 generations on · 0 of its ownK143379 Liquichek Maternal Serum II ControlBio-Rad Laboratories · 2015
- Descendant · 2 generations on · 0 of its ownK133960 Lypochek Specialty Immunoassay ControlBio-Rad Laboratories · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K043108Liquichek Specialty Immunoassay ControlBio-Rad Laboratories, Inc. · 2004 · cites it directly5descendants
- K110641Fujirebio Diagnostics Vitamin D ControlFujirebio Diagnostics,Inc. · 2011 · 2 generations on1descendant
- K984594Lyphochek Maternal Serum Control, Model 220Bio-Rad · 1999 · cites it directly1descendant
- K143379Liquichek Maternal Serum II ControlBio-Rad Laboratories · 2015 · 2 generations on0descendants
- K133960Lypochek Specialty Immunoassay ControlBio-Rad Laboratories · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891475 | Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3 | Bio-Rad | 1989 | — |
| 0 (this device) | K981532 | Lyphochek Immunoassay Plus Control | Bio-Rad | 1998 | — |
| +1 | K043108 | Liquichek Specialty Immunoassay Control | Bio-Rad Laboratories, Inc. | 2004 | — |
| +2 | K110641 | Fujirebio Diagnostics Vitamin D Control | Fujirebio Diagnostics,Inc. | 2011 | — |
| +1 | K984594 | Lyphochek Maternal Serum Control, Model 220 | Bio-Rad | 1999 | — |
| +2 | K143379 | Liquichek Maternal Serum II Control | Bio-Rad Laboratories | 2015 | — |
| +2 | K133960 | Lypochek Specialty Immunoassay Control | Bio-Rad Laboratories | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K891475 | Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3Summary page 1…ality Control Material (Assayed and Unassayed) Devices to Which Substantial Equivalence is Claimed Lyphochek Immunoassay Plus Control Bio-Rad Laboratories, Irvine, CA K891475 Statement of Intended Use Lyphochek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor… | 1989 |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043108 | Liquichek Specialty Immunoassay Control | 2004 | 5 |
| K984594 | Lyphochek Maternal Serum Control, Model 220 | 1999 | 1 |
| K121603 | Randox Immunoassay Speciality Control (II), Level 1, Level 2 and Level 3 | 2012 | 0 |
| K110616 | Thermo Scientific Mas Omni-Immune, Mas Omni Immune Pro | 2011 | 0 |
| K050536 | Quest Diagnostics Immunoassay/TDM Control | 2005 | 0 |
| K990016 | Vitros Immunodiagnostic Products Anemia Controls | 1999 | 0 |
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?
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 Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981532: Lyphochek Immunoassay Plus Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981532
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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