510(k) · Cleared
ClearedCedia Core TDM Multi-Cal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jun 13, 1996 as substantially equivalent to K914857 (Microgenics Corp., 1992) and 3 other predicates after a 44-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Jun 13, 1996
- Review
- 44 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K904413 (1990). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK904413 Cedia (TM) Phenobarbital AssayMicrogenics Corp. · 1990
- This deviceK961659 Cedia Core TDM Multi-CalBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 0 of its ownK120936 Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS…Microgenics Corporation · 2012
Most influential descendants
Showing 1 of 1 · See all- K120936Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent…Microgenics Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904413 | Cedia (TM) Phenobarbital Assay | Microgenics Corp. | 1990 | — |
| 0 (this device) | K961659 | Cedia Core TDM Multi-Cal | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K120936 | Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS… | Microgenics Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914857 | Cedia (R) Carbamazepine AssaySummary page 1…n name: Calibrators, drug mixture The Boehringer Mannheim CEDIA Core TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA Carbamazepine (K914857), Phenobarbital (K904413), Phenytoin (K905689), Theophylline (K961462), and Valproic Acid (930734/2) Assays.. The CEDIA Core TDM… | 1992 |
| * | K904413 | Cedia (TM) Phenobarbital AssaySummary page 1…mixture The Boehringer Mannheim CEDIA Core TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA Carbamazepine (K914857), Phenobarbital (K904413), Phenytoin (K905689), Theophylline (K961462), and Valproic Acid (930734/2) Assays.. The CEDIA Core TDM Calibrators are manufact… | 1990 |
| * | K905689 | Cedia Phenytoin AssaySummary page 1…ger Mannheim CEDIA Core TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA Carbamazepine (K914857), Phenobarbital (K904413), Phenytoin (K905689), Theophylline (K961462), and Valproic Acid (930734/2) Assays.. The CEDIA Core TDM Calibrators are manufactured using bovine ser… | 1991 |
| Kept off the family tree | K961462 | FDA’s K961462 is Cedia Theophylline Assay Our OCR of the scanned summary read K961462, which FDA decided on Jun 27, 1996, after this device was decided (Jun 13, 1996), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1…TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA Carbamazepine (K914857), Phenobarbital (K904413), Phenytoin (K905689), Theophylline (K961462), and Valproic Acid (930734/2) Assays.. The CEDIA Core TDM Calibrators are manufactured using bovine serum albumin, carbamazepin… | 1996 |
| * | K930734 | Cedia Valporic Acid AssaySummary page 1…lly equivalent to the kit calibrators included in CEDIA Carbamazepine (K914857), Phenobarbital (K904413), Phenytoin (K905689), Theophylline (K961462), and Valproic Acid (930734/2) Assays.. The CEDIA Core TDM Calibrators are manufactured using bovine serum albumin, carbamazepine, phenobarbital, phenytoin,… | 1993 |
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 |
|---|---|---|---|
| K120936 | Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent… | 2012 | 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?
- None of the 4 ancestors has a recall.
- Of its descendants, K120936 (Microgenics Corporation, 2012) has gone furthest, with 0 descendants of its own.
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?
The CEDIA Core TDM Multi-Cals are used to calibrate the CEDIA assays for carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid in human serum and plasma.
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/K961659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961659: Cedia Core TDM Multi-Cal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961659
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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