510(k) · Cleared
ClearedLiquichek Specialty Immunoassay Control
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 Dec 7, 2004 as substantially equivalent to K981532 (Bio-Rad, 1998) after a 28-day review. Its family tree reaches back 2 generations to 1989. 5 later devices descend from it.
- Decided
- Dec 7, 2004
- Review
- 28 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K891475 (1989). 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK891475 Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3Bio-Rad · 1989
- 1 generation backK981532 Lyphochek Immunoassay Plus ControlBio-Rad · 1998
- This deviceK043108 Liquichek Specialty Immunoassay ControlBio-Rad Laboratories, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK110641 Fujirebio Diagnostics Vitamin D ControlFujirebio Diagnostics,Inc. · 2011
- Descendant · cites it directly · 0 of its ownK133960 Lypochek Specialty Immunoassay ControlBio-Rad Laboratories · 2014
- Descendant · cites it directly · 0 of its ownK130337 Randox Speciality Control (I) Levels 1, 2 and 3Randox Laboratories Limited · 2013
- Descendant · 2 generations on · 0 of its ownK113177 Complete D 25-OH Vitamin D ControlQuantimetrix Corp. · 2012
- Descendant · cites it directly · 0 of its ownK092749 Mas and Mini-Trol PTH ControlMicrogenics Corporation · 2009
Most influential descendants
Showing 5 of 5 · See all- K110641Fujirebio Diagnostics Vitamin D ControlFujirebio Diagnostics,Inc. · 2011 · cites it directly1descendant
- K133960Lypochek Specialty Immunoassay ControlBio-Rad Laboratories · 2014 · cites it directly0descendants
- K130337Randox Speciality Control (I) Levels 1, 2 and 3Randox Laboratories Limited · 2013 · cites it directly0descendants
- K113177Complete D 25-OH Vitamin D ControlQuantimetrix Corp. · 2012 · 2 generations on0descendants
- K092749Mas and Mini-Trol PTH ControlMicrogenics Corporation · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891475 | Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3 | Bio-Rad | 1989 | — |
| −1 | K981532 | Lyphochek Immunoassay Plus Control | Bio-Rad | 1998 | — |
| 0 (this device) | K043108 | Liquichek Specialty Immunoassay Control | Bio-Rad Laboratories, Inc. | 2004 | — |
| +1 | K110641 | Fujirebio Diagnostics Vitamin D Control | Fujirebio Diagnostics,Inc. | 2011 | — |
| +1 | K133960 | Lypochek Specialty Immunoassay Control | Bio-Rad Laboratories | 2014 | — |
| +1 | K130337 | Randox Speciality Control (I) Levels 1, 2 and 3 | Randox Laboratories Limited | 2013 | — |
| +2 | K113177 | Complete D 25-OH Vitamin D Control | Quantimetrix Corp. | 2012 | — |
| +1 | K092749 | Mas and Mini-Trol PTH Control | Microgenics Corporation | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K981532 | Lyphochek Immunoassay Plus ControlSummary page 1…ivalence is Claimed Lyphochek Immunoassay Plus Control Bio-Rad Laboratories Irvine, California 510 (k) Number: K981532 4.0 Description of Device Liquichek Specialty Immunoassay Control is prepared from human serum with added con… | 1998 |
What descends from it? (5)
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 15 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K110641 (Fujirebio Diagnostics,Inc., 2011) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K981532.
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?
Liquichek Specialty Immunoassay Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043108: Liquichek Specialty Immunoassay Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043108
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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