510(k) · Cleared
ClearedImmunoassay Plus Control, Levels 1, 2, and 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consolidated Technology · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Mar 19, 2002 as substantially equivalent to K992939 (Seracare Technology, 1999) after a 55-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Mar 19, 2002
- Review
- 55 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992939 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK992939 Qualitrol Immunoassay Plus Control, Levels 1,2 and 3Seracare Technology · 1999
- This deviceK020237 Immunoassay Plus Control, Levels 1, 2, and 3Consolidated Technology · 2002
- Descendant · cites it directly · 0 of its ownK033344 Ligand Plus Control Level 1-3Consolidated Technology · 2004
Most influential descendants
Showing 1 of 1 · See all- K033344Ligand Plus Control Level 1-3Consolidated Technology · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992939 | Qualitrol Immunoassay Plus Control, Levels 1,2 and 3 | Seracare Technology | 1999 | — |
| 0 (this device) | K020237 | Immunoassay Plus Control, Levels 1, 2, and 3 | Consolidated Technology | 2002 | — |
| +1 | K033344 | Ligand Plus Control Level 1-3 | Consolidated Technology | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K992939 | Qualitrol Immunoassay Plus Control, Levels 1,2 and 3Summary page 1…roduct code: JJY 21 CFR 862:1660: Multi-Analyte Controls, All Kinds (Assayed and Unassayed) Predicate device: QUALITROL IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3 (510K 992939) Device description: IMMUNOASSAY PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochem… | 1999 |
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 |
|---|---|---|---|
| K033344 | Ligand Plus Control Level 1-3 | 2004 | 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?
- Its one ancestor has no recall.
- Of its descendants, K033344 (Consolidated Technology, 2004) 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?
IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and theraputic drugs as listed in this package insert.
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/K020237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020237: Immunoassay Plus Control, Levels 1, 2, and 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020237
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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