510(k) · Cleared
ClearedLiquichek Immunology Control Level 1, 2, and 3-1 ML, Model 591, 592, 593; Level 1, 2, and 3-3 ML, Model 594, 595, 596
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 Sep 17, 2002 as substantially equivalent to K011494 (Bio-Rad, 2001) after an 8-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Sep 17, 2002
- Review
- 8 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011494 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK011494 Liquichek Immunology Control Level 1,2,3,1, ML, Liquichek Immunology…Bio-Rad · 2001
- This deviceK022991 Liquichek Immunology Control Level 1, 2, and 3-1 ML, Model 591, 592…Bio-Rad · 2002
- Descendant · cites it directly · 0 of its ownK140764 Liquichek Immunologycontrol-Level 1,Level 2, Level 3, MinipakBio-Rad Laboratories · 2014
- Descendant · cites it directly · 0 of its ownK131992 Multichem PTechno-Path Manufacturing, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK130761 Liquichek Immunology Control, Level 1,2,3, Trilevel MinipakBio-Rad Laboratories · 2013
Most influential descendants
Showing 3 of 3 · See all- K140764Liquichek Immunologycontrol-Level 1,Level 2, Level 3, MinipakBio-Rad Laboratories · 2014 · cites it directly0descendants
- K131992Multichem PTechno-Path Manufacturing, Ltd. · 2013 · cites it directly0descendants
- K130761Liquichek Immunology Control, Level 1,2,3, Trilevel MinipakBio-Rad Laboratories · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011494 | Liquichek Immunology Control Level 1,2,3,1, ML, Liquichek Immunology Control… | Bio-Rad | 2001 | — |
| 0 (this device) | K022991 | Liquichek Immunology Control Level 1, 2, and 3-1 ML, Model 591, 592, 593… | Bio-Rad | 2002 | — |
| +1 | K140764 | Liquichek Immunologycontrol-Level 1,Level 2, Level 3, Minipak | Bio-Rad Laboratories | 2014 | — |
| +1 | K131992 | Multichem P | Techno-Path Manufacturing, Ltd. | 2013 | — |
| +1 | K130761 | Liquichek Immunology Control, Level 1,2,3, Trilevel Minipak | Bio-Rad Laboratories | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K011494 | Liquichek Immunology Control Level 1,2,3,1, ML, Liquichek Immunology Control Level 1, 3… | 2001 |
What descends from it? (3)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K140764 (Bio-Rad Laboratories, 2014) has gone furthest, with 0 descendants of its own.
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?
An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022991: Liquichek Immunology Control Level 1, 2, and 3-1 ML, Model 591, 592, 593; Level 1, 2, and 3-3 ML, Model 594, 595, 596.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022991
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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