510(k) · Cleared
ClearedBayer Ligand Plus 1, 2, 3 Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Mar 3, 2003 as substantially equivalent to K901212 (Ciba Corning Diagnostics Corp., 1990) after a 20-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.
- Decided
- Mar 3, 2003
- Review
- 20 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901212 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK901212 Lig/TDM a, B, CCiba Corning Diagnostics Corp. · 1990
- This deviceK030452 Bayer Ligand Plus 1, 2, 3 ControlsBayer Diagnostics Corp. · 2003
- Descendant · cites it directly · 1 of its ownK060359 Archiect Insulin and Controls, Model 8K41-01, 8K41-10Denka Seiken Co., Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK171168 VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics · 2017
- Descendant · cites it directly · 0 of its ownK082141 Architect C-Peptide Calibrators, and Architect C-Peptide Controls…Biokit, S.A. · 2008
Most influential descendants
Showing 3 of 3 · See all- K060359Archiect Insulin and Controls, Model 8K41-01, 8K41-10Denka Seiken Co., Ltd. · 2006 · cites it directly1descendant
- K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics · 2017 · 2 generations on0descendants
- K082141Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10Biokit, S.A. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901212 | Lig/TDM a, B, C | Ciba Corning Diagnostics Corp. | 1990 | — |
| 0 (this device) | K030452 | Bayer Ligand Plus 1, 2, 3 Controls | Bayer Diagnostics Corp. | 2003 | — |
| +1 | K060359 | Archiect Insulin and Controls, Model 8K41-01, 8K41-10 | Denka Seiken Co., Ltd. | 2006 | — |
| +2 | K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | 2017 | — |
| +1 | K082141 | Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models… | Biokit, S.A. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K901212 | Lig/TDM a, B, CSummary page 1…Chemistry (75) Product Code: JJY Predicate Device: Ligand Plus 1,2,3 Controls Premarket Notification Number: K901212 Bayer Healthcare.---Confidential… | 1990 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K060359 (Denka Seiken Co., Ltd., 2006) has gone furthest, with 1 descendant 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?
Assayed control material for in vitro diagnostic use to monitor the precision and
accuracy of immunochemistry test procedures for the ADVIA Centaur@
andACS: 1808 Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030452 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030452: Bayer Ligand Plus 1, 2, 3 Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030452
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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