510(k) · Cleared
ClearedCliniqa Liquid QC Lipid Control Levels 1 & 2;Linical Lipid Calibration Verifiers Levels a-E for Olympus AU Systems;Qalib
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cliniqa Corporation · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on May 25, 2006 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 25, 2006
- Review
- 28 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK061182 Cliniqa Liquid QC Lipid Control Levels 1 & 2;Linical Lipid…Cliniqa Corporation · 2006
- Descendant · cites it directly · 0 of its ownK132031 Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS · 2014
Most influential descendants
Showing 1 of 1 · See all- K132031Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061182 | Cliniqa Liquid QC Lipid Control Levels 1 & 2;Linical Lipid Calibration… | Cliniqa Corporation | 2006 | — |
| +1 | K132031 | Afinion Lipid Panel and Afinion Lipid Panel Control | Axis-Shield Poc AS | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K132031 | Afinion Lipid Panel and Afinion Lipid Panel Control | 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?
- Of its descendants, K132031 (Axis-Shield Poc AS, 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?
CLINIQA Liquid QC Lipid Controls Levels 1 and 2 are intended for use as assayed quality control material for Apolipoprotein A-1, Apolipoprotein B, Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein and Triglyceride analysis. CLINIQA LiniCAL Lipid Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Cholesterol…
Read the full statement (103 words)
CLINIQA Liquid QC Lipid Controls Levels 1 and 2 are intended for use as assayed quality control material for Apolipoprotein A-1, Apolipoprotein B, Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein and Triglyceride analysis.
CLINIQA LiniCAL Lipid Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein and Triglyceride at five useful concentrations.
CLINIQA QALIBRATE - Lipid Calibrator is intended for use in assay method calibration for clinical chemistry analyzers listed in the product insert.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061182 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061182: Cliniqa Liquid QC Lipid Control Levels 1 & 2;Linical Lipid Calibration Verifiers Levels a-E for Olympus AU Systems;Qalib.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061182
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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