510(k) · Cleared
ClearedDade Moni-Trol Candidate Product Combinations
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Intl., Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Apr 26, 1996 as substantially equivalent to K871977 (American Dade, 1987) and 1 other predicate after a 106-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Apr 26, 1996
- Review
- 106 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K871977 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK871977 Dade Moni-Trol Chemistry Control/CalibratorAmerican Dade · 1987
- This deviceK960103 Dade Moni-Trol Candidate Product CombinationsDade Intl., Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871977 | Dade Moni-Trol Chemistry Control/Calibrator | American Dade | 1987 | — |
| 0 (this device) | K960103 | Dade Moni-Trol Candidate Product Combinations | Dade Intl., Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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 JIX? 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? (12)
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 |
|---|---|---|---|
| * | K871977 | Dade Moni-Trol Chemistry Control/CalibratorSummary page 1…rbonate Diluent 2 e Moni-Trol® Calibrator A, Moni-Trol® Calibrator B and Moni-Trol® Calibrator C Predicate Devices: ¢ Dade® Moni-Trol® Chemistry Control / Calibrator (K871977); Moni-Trol® and Other Brand names Chemistry Control / Calibrator, (K891929/A); Dade® Urine Chemistry Control; Dade®Immunoassay C… | 1987 |
| * | K891929 | Moni-Trol (R)Summary page 1…ni-Trol® Calibrator C Predicate Devices: ¢ Dade® Moni-Trol® Chemistry Control / Calibrator (K871977); Moni-Trol® and Other Brand names Chemistry Control / Calibrator, (K891929/A); Dade® Urine Chemistry Control; Dade®Immunoassay Control, Dade® Anemia/Hemochromatosis Control; Dade® CK/LD Control e BIO-RAD… | 1989 |
| * | — | Dade® Urine Chemistry Control Named without a submission number | |
| * | — | Dade® Immunoassay Control Named without a submission number | |
| * | — | Dade® Anemia/Hemochromatosis Control Named without a submission number | |
| * | — | Dade® CK/LD Control Named without a submission number | |
| * | — | BIO-RAD Lyphochek® Chemistry Control Named without a submission number | |
| * | — | Liquichek™ Immunology Control Named without a submission number | |
| * | — | Liquichek™ Rheumatoid Factor Control Named without a submission number | |
| * | — | CIBA-CORNING QCS® Control Serum Named without a submission number | |
| * | — | Boehringer Mannheim Precical® Named without a submission number | |
| * | — | Beckman CAL 1 Named without a submission number |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Dade® Moni-Trol® Control is intended for use as an unassayed quality control material in quantitative clinical chemistry control programs.
Dade® Moni-Trol® Control is intended to assist in the control of accuracy and precision of clinical chemistry quality control programs.
Dade® Moni-Trol® Calibrator is intended for use as a calibrator in the quantitative determination of clinical assays.
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/K960103 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960103: Dade Moni-Trol Candidate Product Combinations.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960103
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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