510(k) · Cleared
ClearedLiquid Assayed Multiqual Premium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Mar 1, 2013 as substantially equivalent to K100727 (Bio-Rad, Diagnostics Grp., 2010) after a 37-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Mar 1, 2013
- Review
- 37 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K923633 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK923633 Multiqual Assay ProductsCiba Corning Diagnostics Corp. · 1992
- 3 generations backK011867 Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700…Bio-Rad · 2001
- 2 generations backK043208 Liquid Assayed Multiqual ControlBio-Rad · 2005
- 1 generation backK100727 Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid…Bio-Rad, Diagnostics Grp. · 2010
- This deviceK130162 Liquid Assayed Multiqual PremiumBio-Rad Laboratories · 2013
- Descendant · cites it directly · 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 1 of 1 · See all- K140971Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.Randox Laboratories Limited · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923633 | Multiqual Assay Products | Ciba Corning Diagnostics Corp. | 1992 | — |
| −3 | K011867 | Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3… | Bio-Rad | 2001 | — |
| −2 | K043208 | Liquid Assayed Multiqual Control | Bio-Rad | 2005 | — |
| −1 | K100727 | Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed… | Bio-Rad, Diagnostics Grp. | 2010 | — |
| 0 (this device) | K130162 | Liquid Assayed Multiqual Premium | Bio-Rad Laboratories | 2013 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K100727 | Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed Multiqual 3…Summary page 1…Device Name: Liquid Assayed Multiqual Applicant: Bio-Rad Laboratories 510O(k) Number: K100727 Product Code: JJY Regulation #*: 862.1660 IDevice Classifica… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3. | 2014 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K140971 (Randox Laboratories Limited, 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. 2013, 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 Premium is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130162: Liquid Assayed Multiqual Premium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130162
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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