510(k) · Cleared
ClearedLiquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed Multiqual 3, Liquid Assayed Multiqual Minipak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad, Diagnostics Grp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Sep 14, 2010 as substantially equivalent to K043208 (Bio-Rad, 2005) after a 183-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.
- Decided
- Sep 14, 2010
- Review
- 183 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923633 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK923633 Multiqual Assay ProductsCiba Corning Diagnostics Corp. · 1992
- 2 generations backK011867 Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700…Bio-Rad · 2001
- 1 generation backK043208 Liquid Assayed Multiqual ControlBio-Rad · 2005
- This deviceK100727 Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid…Bio-Rad, Diagnostics Grp. · 2010
- Descendant · cites it directly · 1 of its ownK130162 Liquid Assayed Multiqual PremiumBio-Rad Laboratories · 2013
- Descendant · 2 generations on · 0 of its ownK140971 Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.Randox Laboratories Limited · 2014 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923633 | Multiqual Assay Products | Ciba Corning Diagnostics Corp. | 1992 | — |
| −2 | K011867 | Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3… | Bio-Rad | 2001 | — |
| −1 | K043208 | Liquid Assayed Multiqual Control | Bio-Rad | 2005 | — |
| 0 (this device) | K100727 | Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed… | Bio-Rad, Diagnostics Grp. | 2010 | — |
| +1 | K130162 | Liquid Assayed Multiqual Premium | Bio-Rad Laboratories | 2013 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K043208 | Liquid Assayed Multiqual ControlSummary page 1…ce to Which Substantial Equivalence is Claimed Liquid Assayed Multiqual Bio-Rad Laboratories Irvine, California 510 (k) Number: K043208 4.0 Description of Device Liquid Assayed Multiqual is prepared from human serum to which purified biochemical… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130162 | Liquid Assayed Multiqual Premium | 2013 | 1 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K130162 (Bio-Rad Laboratories, 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K043208.
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. 2010, this device’s year, is highlighted.
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?
Liquid Assayed Multiqual 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/K100727 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100727: Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed Multiqual 3, Liquid Assayed Multiqual Minipak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100727
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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