510(k) · Cleared
ClearedLiquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3 #981800
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 Jul 12, 2001 as substantially equivalent to K923633 (Ciba Corning Diagnostics Corp., 1992) after a 28-day review. Its family tree reaches back 1 generation to 1992. 8 later devices descend from it.
- Decided
- Jul 12, 2001
- Review
- 28 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923633 (1992). 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK923633 Multiqual Assay ProductsCiba Corning Diagnostics Corp. · 1992
- This deviceK011867 Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700…Bio-Rad · 2001
- Descendant · cites it directly · 4 of its ownK043208 Liquid Assayed Multiqual ControlBio-Rad · 2005
- Descendant · 2 generations on · 2 of its ownK100727 Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid…Bio-Rad, Diagnostics Grp. · 2010
- Descendant · 3 generations on · 1 of its ownK130162 Liquid Assayed Multiqual PremiumBio-Rad Laboratories · 2013
- Descendant · cites it directly · 1 of its ownK033387 Quest Diagnostics Serum Chemistry Control, Models 935 and 945Bio-Rad · 2003
- Descendant · 4 generations on · 0 of its ownK140971 Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.Randox Laboratories Limited · 2014 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K043208Liquid Assayed Multiqual ControlBio-Rad · 2005 · cites it directly4descendants
- K100727Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed Multiqual 3…Bio-Rad, Diagnostics Grp. · 2010 · 2 generations on2descendants
- K130162Liquid Assayed Multiqual PremiumBio-Rad Laboratories · 2013 · 3 generations on1descendant
- K033387Quest Diagnostics Serum Chemistry Control, Models 935 and 945Bio-Rad · 2003 · cites it directly1descendant
- K140971Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.Randox Laboratories Limited · 2014 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923633 | Multiqual Assay Products | Ciba Corning Diagnostics Corp. | 1992 | — |
| 0 (this device) | K011867 | Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3… | Bio-Rad | 2001 | — |
| +1 | K043208 | Liquid Assayed Multiqual Control | Bio-Rad | 2005 | — |
| +2 | K100727 | Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed… | Bio-Rad, Diagnostics Grp. | 2010 | — |
| +3 | K130162 | Liquid Assayed Multiqual Premium | Bio-Rad Laboratories | 2013 | — |
| +1 | K033387 | Quest Diagnostics Serum Chemistry Control, Models 935 and 945 | Bio-Rad | 2003 | — |
| +4 | K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3. | Randox Laboratories Limited | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K923633 | Multiqual Assay ProductsSummary page 1….0 Device to Which Substantial Equivalence is Claimed MULTIQUAL® ASY 1, II, 1l Ciba Corning Diagnostics Corp. (Bio-Rad Laboratories) Irvine, California Docket Number: K923633 4.0 Description of Device Liquid Assayed Multiqual® Control is prepared from human serum to which purified biochemical material… | 1992 |
What descends from it? (8)
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, K043208 (Bio-Rad, 2005) has gone furthest, with 4 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011867: Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3 #981800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011867
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026