510(k) · Cleared
ClearedLyphochek (R) Immunoassay Contr Serum (Human) 1,2,3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Aug 1, 1989 after a 138-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- Aug 1, 1989
- Review
- 138 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 3 citing it directly.
- This deviceK891475 Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3Bio-Rad · 1989
- Descendant · cites it directly · 12 of its ownK981532 Lyphochek Immunoassay Plus ControlBio-Rad · 1998
- Descendant · 2 generations on · 5 of its ownK043108 Liquichek Specialty Immunoassay ControlBio-Rad Laboratories, Inc. · 2004
- Descendant · 3 generations on · 1 of its ownK110641 Fujirebio Diagnostics Vitamin D ControlFujirebio Diagnostics,Inc. · 2011
- Descendant · cites it directly · 1 of its ownK060205 General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · Recalled
- Descendant · 2 generations on · 1 of its ownK984594 Lyphochek Maternal Serum Control, Model 220Bio-Rad · 1999
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K981532Lyphochek Immunoassay Plus ControlBio-Rad · 1998 · cites it directly12descendants
- K043108Liquichek Specialty Immunoassay ControlBio-Rad Laboratories, Inc. · 2004 · 2 generations on5descendants
- K110641Fujirebio Diagnostics Vitamin D ControlFujirebio Diagnostics,Inc. · 2011 · 3 generations on1descendant
- K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · cites it directly1descendant
- K984594Lyphochek Maternal Serum Control, Model 220Bio-Rad · 1999 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891475 | Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3 | Bio-Rad | 1989 | — |
| +1 | K981532 | Lyphochek Immunoassay Plus Control | Bio-Rad | 1998 | — |
| +2 | K043108 | Liquichek Specialty Immunoassay Control | Bio-Rad Laboratories, Inc. | 2004 | — |
| +3 | K110641 | Fujirebio Diagnostics Vitamin D Control | Fujirebio Diagnostics,Inc. | 2011 | — |
| +1 | K060205 | General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2006 | 2 |
| +2 | K984594 | Lyphochek Maternal Serum Control, Model 220 | Bio-Rad | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJX? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 173 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?
- Of its descendants, K981532 (Bio-Rad, 1998) has gone furthest, with 12 descendants of its own.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K891475 · printed Nov 5, 2026
Cite this page
510(k) Report. “K891475: Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K891475
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026