510(k) · Cleared
ClearedAbbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corporation · DKB Calibrators, Drug Mixture
Cleared on Dec 13, 2012 as substantially equivalent to K961659 (Boehringer Mannheim Corp., 1996) after a 260-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Dec 13, 2012
- Review
- 260 days
- Class
- Class II
- Product code
- DKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904413 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904413 | Cedia (TM) Phenobarbital Assay | Microgenics Corp. | 1990 | — |
| −1 | K961659 | Cedia Core TDM Multi-Cal | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | 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 |
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 DKB? 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? (1)
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 |
|---|---|---|---|
| * | K961659 | Cedia Core TDM Multi-CalSummary page 2…d The TDM Multiconstituent Calibrator set and QMS® TDM Multi-Constituent Calibrator set are substantially equivalent to the previously cleared CEDIA TOM Core Multi-Cals (K961659). Device Description Each TOM Multiconstituent Calibrator set and QMS® TDM Multi-Constituent Calibrator set is packaged in a rec… | 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 22 years and passes through 3 companies; a new generation was cleared every 16.5 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All DKB devicesDKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DKB
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DKB
Too few DKB 510(k)s in any year since 2007 to give a median.
Recalls per year · DKB
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKB
1in 2017
MAUDE reports naming product code DKB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 2 | 1 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Abbott TDM Multiconstituent Calibrator For in vitro diagnostic use in the calibration of the Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobatbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin human serum and plasma assays on the ARCHITECT cSystems. Lot-specific calibrator for the ARCHITECT cSystems are listed in the TDM MCC Value Sheet, packaged with the calibrator. Thermo Scientific QMSO Multi-Constituent Calibrator For in…
Read the full statement (111 words)
Abbott TDM Multiconstituent Calibrator
For in vitro diagnostic use in the calibration of the Amikacin, Carbamazepine, Digoxin,
Gentamicin, Phenobatbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin
human serum and plasma assays on the ARCHITECT cSystems.
Lot-specific calibrator for the ARCHITECT cSystems are listed in the TDM MCC Value Sheet,
packaged with the calibrator.
Thermo Scientific QMSO Multi-Constituent Calibrator
For in vitro diagnostic use in the calibration of assays for the detection of Amikacin,
Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline,
Vaiproic Acid, and Vancomycin in human serum and plasma for use on clinical laboratory
analyzers.
Lot-specific calibrator values with specific analyzers are provided in the value sheet packaged
with the calibrator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120936 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120936: Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120936
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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