510(k) · Cleared
ClearedImmunology Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Analysis Systems, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Apr 23, 1996 after a 54-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 23, 1996
- Review
- 54 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK960824 Immunology ControlMedical Analysis Systems, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK123725 Fastpack Control KitQualigen, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK110738 Thermo Scientific Mas Omni-CoreMicrogenics Corporation · 2011
- Descendant · cites it directly · 0 of its ownK063150 Complement C3 and C4, Specical Calibrator and Specitrol Control and…Thermo Electron OY · 2007
Most influential descendants
Showing 3 of 3 · See all- K123725Fastpack Control KitQualigen, Inc. · 2013 · cites it directly0descendants
- K110738Thermo Scientific Mas Omni-CoreMicrogenics Corporation · 2011 · cites it directly0descendants
- K063150Complement C3 and C4, Specical Calibrator and Specitrol Control and High ControlThermo Electron OY · 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) | K960824 | Immunology Control | Medical Analysis Systems, Inc. | 1996 | — |
| +1 | K123725 | Fastpack Control Kit | Qualigen, Inc. | 2013 | — |
| +1 | K110738 | Thermo Scientific Mas Omni-Core | Microgenics Corporation | 2011 | — |
| +1 | K063150 | Complement C3 and C4, Specical Calibrator and Specitrol Control and High Control | Thermo Electron OY | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
3 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?
- Of its descendants, K123725 (Qualigen, Inc., 2013) 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 | — |
https://510kreport.com/device/K960824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960824: Immunology Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960824
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026