510(k) · Cleared
ClearedMas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry 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 28, 2003 after a 33-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Apr 28, 2003
- Review
- 33 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK030942 Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry ControlMedical Analysis Systems, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK092051 Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed…Microgenics Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK110738 Thermo Scientific Mas Omni-CoreMicrogenics Corporation · 2011
- Descendant · cites it directly · 0 of its ownK050983 Irma Trupoint Creatinine Control KitInternational Technidyne Corporation · 2005
Most influential descendants
Showing 3 of 3 · See all- K092051Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed Chemistry Control, Model…Microgenics Corp. · 2009 · cites it directly1descendant
- K110738Thermo Scientific Mas Omni-CoreMicrogenics Corporation · 2011 · 2 generations on0descendants
- K050983Irma Trupoint Creatinine Control KitInternational Technidyne Corporation · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K110738 | Thermo Scientific Mas Omni-Core | Microgenics Corporation | 2011 | — |
| +1 | K050983 | Irma Trupoint Creatinine Control Kit | International Technidyne Corporation | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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, K092051 (Microgenics Corp., 2009) has gone furthest, with 1 descendant 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?
The MAS® chemTRAK® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK® H 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.…
Read the full statement (206 words)
The MAS® chemTRAK® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK® H 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.
The DADE® 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 DADE® Moni-Trol® H 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.
The OLYMPUS Chemistry Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Chemistry Control 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 510(k) statement.
https://510kreport.com/device/K030942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030942: Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030942
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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