510(k) · Cleared
ClearedLinical Protein 2 Calibration Verifiers Levels a-E for Olympus AU Analyzers
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 Jul 23, 2003 after a 64-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 23, 2003
- Review
- 64 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK031575 Linical Protein 2 Calibration Verifiers Levels a-E for Olympus AU…Cliniqa Corporation · 2003
- Descendant · cites it directly · 0 of its ownK072246 Validate SP1 Calibration Verification/Linearity Test Set, Model 601Maine Standards Co. · 2007
Most influential descendants
Showing 1 of 1 · See all- K072246Validate SP1 Calibration Verification/Linearity Test Set, Model 601Maine Standards Co. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031575 | Linical Protein 2 Calibration Verifiers Levels a-E for Olympus AU Analyzers | Cliniqa Corporation | 2003 | — |
| +1 | K072246 | Validate SP1 Calibration Verification/Linearity Test Set, Model 601 | Maine Standards Co. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| K072246 | Validate SP1 Calibration Verification/Linearity Test Set, Model 601 | 2007 | 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, K072246 (Maine Standards Co., 2007) 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?
CLlNlQA LiniCAL'" Protein 2 Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Ofympus* AU Analyzers. Five assayed levels of Anti Streptolysin 0, C-Reactive Protein. Complement C3, Complement C4, Ferritin, lrnmunoglobulinA, Immunoglobulin G, Immunoglobulin M, Prealbumin and Transferrin are provided to allow monitoring of the reportable range.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031575: Linical Protein 2 Calibration Verifiers Levels a-E for Olympus AU Analyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031575
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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