510(k) · Cleared
ClearedThermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed Chemistry Control, Model, Cha, Chu, M5155, M5158
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 Sep 21, 2009 as substantially equivalent to K030942 (Medical Analysis Systems, Inc., 2003) after a 76-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Sep 21, 2009
- Review
- 76 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030942 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK030942 Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry ControlMedical Analysis Systems, Inc. · 2003
- This deviceK092051 Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed…Microgenics Corp. · 2009
- Descendant · cites it directly · 0 of its ownK110738 Thermo Scientific Mas Omni-CoreMicrogenics Corporation · 2011
Most influential descendants
Showing 1 of 1 · See all- K110738Thermo Scientific Mas Omni-CoreMicrogenics Corporation · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030942 | Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry Control | Medical Analysis Systems, Inc. | 2003 | — |
| 0 (this device) | K092051 | Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed Chemistry… | Microgenics Corp. | 2009 | — |
| +1 | K110738 | Thermo Scientific Mas Omni-Core | Microgenics Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K030942 | Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry ControlSummary page 2…chemTRAK® H and Thermo Scientific Moni-Trol® H are substantially equivalent to the previously cleared MAS® chemTRAK® H, DADE® Moni-Trol® H and OLYMPUS Chemistry Control (K030942) DESCRIPTION OF DEVICE This product is a liquid stable control material prepared from human serum. Analyte levels are adjusted… | 2003 |
| * | — | MAS® chemTRAK® H Named without a submission number | |
| * | — | DADE® Moni-Trol® H Named without a submission number |
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 |
|---|---|---|---|
| K110738 | Thermo Scientific Mas Omni-Core | 2011 | 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?
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. 2009, 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?
chemTRAK ® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include chemTRAK® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. Moni-Trol® H is intended for use as a consistent test sample of known…
Read the full statement (116 words)
chemTRAK ® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include chemTRAK® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Moni-Trol® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Moni-Trol ® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations with 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/K092051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092051: Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed Chemistry Control, Model, Cha, Chu, M5155, M5158.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092051
Report an extraction error
Are you the manufacturer?
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