510(k) · Cleared
ClearedThermo Scientific Mas Omni-Core
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corporation · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Nov 3, 2011 as substantially equivalent to K092051 (Microgenics Corp., 2009) and 1 other predicate after a 231-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Nov 3, 2011
- Review
- 231 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K030942 (2003). 3 ancestors in all, the oldest K960824 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK030942 Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry ControlMedical Analysis Systems, Inc. · 2003
- 1 generation backK092051 Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed…Microgenics Corp. · 2009
- This deviceK110738 Thermo Scientific Mas Omni-CoreMicrogenics Corporation · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030942 | Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry Control | Medical Analysis Systems, Inc. | 2003 | — |
| −1 | K092051 | Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed Chemistry… | Microgenics Corp. | 2009 | — |
| 0 (this device) | K110738 | Thermo Scientific Mas Omni-Core | Microgenics Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (2)
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 |
|---|---|---|---|
| * | K092051 | Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed Chemistry Control, Model…Summary page 1…of reagent and instrument. Legally marketed device to which equivalency is claimed MAS®Omni-CORE is substantially equivalent to the previously cleared MAS®Chem-TRAK H (K092051) and MAS® Immunology (K960824) Controls.… | 2009 |
| * | K960824 | Immunology ControlSummary page 1…egally marketed device to which equivalency is claimed MAS®Omni-CORE is substantially equivalent to the previously cleared MAS®Chem-TRAK H (K092051) and MAS® Immunology (K960824) Controls. 2 0ia… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 3 ancestors has a recall.
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® OmniCORETM is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include MAS®9 Omni-CORE with patient serum specimens when assaying for any of the constituents. Assay values are provided for the specific systems listed. The user can compare observations with their expected ranges as a means of assuring consistent performance of reagent and instrument.
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/K110738 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110738: Thermo Scientific Mas Omni-Core.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110738
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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