510(k) · Cleared
Recalled · Class II · 2023Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories Limited · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Dec 8, 2014 as substantially equivalent to K130162 (Bio-Rad Laboratories, 2013) after a 236-day review. Its family tree reaches back 5 generations to 1992. It has been recalled 2 times.
- Decided
- Dec 8, 2014
- Review
- 236 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K923633 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK923633 Multiqual Assay ProductsCiba Corning Diagnostics Corp. · 1992
- 4 generations backK011867 Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700…Bio-Rad · 2001
- 3 generations backK043208 Liquid Assayed Multiqual ControlBio-Rad · 2005
- 2 generations backK100727 Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid…Bio-Rad, Diagnostics Grp. · 2010
- 1 generation backK130162 Liquid Assayed Multiqual PremiumBio-Rad Laboratories · 2013
- This deviceK140971 Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.Randox Laboratories Limited · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923633 | Multiqual Assay Products | Ciba Corning Diagnostics Corp. | 1992 | — |
| −4 | K011867 | Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3… | Bio-Rad | 2001 | — |
| −3 | 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 | — |
| −1 | K130162 | Liquid Assayed Multiqual Premium | Bio-Rad Laboratories | 2013 | — |
| 0 (this device) | K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3. | Randox Laboratories Limited | 2014 | — |
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 |
|---|---|---|---|
| * | K130162 | Liquid Assayed Multiqual PremiumSummary page 5…=== 4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS Predicate Device Proprietary Name: Bio-rad Laboratories, Liquid Assayed Multiqual Premium 510 (k) Number: K130162 5. INTENDED USE The Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 and 3 are assayed quality control materials inte… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2023 | Class II | Z-2609-2023 | Under Investigation by firm | there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which… |
| Feb 18, 2020 | Class II | Z-1547-2020 | Under Investigation by firm | The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
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. 2014, 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?
The Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 and 3 are assayed quality control materials intended for in vitro diagnostic use in the quality control of diagnostic assays. This material can be used to monitor the accuracy or reproducibility of analytes listed in the package insert. This device is for prescription use only.
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/K140971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140971: Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140971
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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