510(k) · Cleared
Recalled · Class III · 2013Thermo Scientific Mas Omni-Immune, Mas Omni Immune Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jun 29, 2011 as substantially equivalent to K981532 (Bio-Rad, 1998) after a 118-day review. Its family tree reaches back 2 generations to 1989. It has been recalled 3 times.
- Decided
- Jun 29, 2011
- Review
- 118 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K891475 (1989). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K981532 | Lyphochek Immunoassay Plus ControlSummary page 2…Thermo Scientific MAS Omni*IMMUNE'Control is substantially equivalent td the previously cleared Bio-Rad Laboratories Lyphochek Immunoassay Plus Control (K981 532). Description of Device Omni-IMMUNE is a liquid stable control material prepared from hu… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2013 | Class III | Z-1929-2014 | Labeling Change Control | The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change. |
| Dec 2, 2013 | Class III | Z-1930-2014 | Labeling Change Control | The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change. |
| Aug 20, 2012 | Class III | Z-0379-2013 | Nonconforming Material/Component | In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 13.1 years on median.
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K981532.
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. 2011, this device’s year, is highlighted.
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?
Thermo Scientific MAS® Omni-IMMUNE is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include Omni-IMMUNE with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument Thermo Scientific…
Read the full statement (128 words)
Thermo Scientific MAS® Omni-IMMUNE is intended for use as an assayed control for monitoring
assay conditions in many clinical laboratory determinations. Include Omni-IMMUNE with patient
serum specimens when assaying for any of the listed constituents. Assay values are provided
for the specific systems listed. The user can compare observations with expected ranges as a
means of assuring consistent performance of reagent and instrument
Thermo Scientific MAS® Omni-IMMUNE PRO is intended for use as an assayed control for
monitoring assay conditions in many clinical laboratory determinations. Include Omni-IMMUNE
PRO with patient serum specimens when assaying for any of the listed constituents. Assay
values are provided for the specific systems listed. The user can compare observations with
expected ranges as a means of assuring consistent performance of reagent and instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110616: Thermo Scientific Mas Omni-Immune, Mas Omni Immune Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110616
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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