Abbott TDM Multiconstituent Calibrator For in vitro diagnostic use in the calibration of the Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, 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 QMS® 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, Valproic 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.
Device Story
TDM Multiconstituent Calibrator set consists of 6 levels of liquid, ready-to-use calibrators prepared from a bovine serum matrix; contains analytes amikacin, carbamazepine, digoxin, gentamicin, phenytoin, quinidine, theophylline, valproic acid, and vancomycin. Preserved with sodium azide and ProClin 300. Used in clinical laboratories to calibrate automated analyzers (e.g., ARCHITECT cSystems) for therapeutic drug monitoring. Healthcare providers use the resulting assay calibration to quantify drug concentrations in patient serum/plasma samples. Accurate calibration ensures reliable drug level measurements, supporting clinical decisions regarding dosage adjustments and toxicity monitoring, ultimately benefiting patients by maintaining therapeutic drug ranges.
Clinical Evidence
No clinical data. Bench testing only. Stability validated via accelerated and real-time studies (24-month shelf life at 2-8°C; 60-day open-bottle stability). Traceability established to USP reference standards via gravimetric addition to human serum pools.
Indicated for in vitro diagnostic calibration of therapeutic drug monitoring assays (Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, Vancomycin) in human serum and plasma on clinical laboratory analyzers.
Regulatory Classification
Identification
A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
CEDIA TDM Core Multi-cals (k961659)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k120936
B. Purpose for Submission:
New device
C. Measurand:
Calibrator materials
D. Type of Test:
Not applicable
E. Applicant:
Microgenics Corporation
F. Proprietary and Established Names:
Abbott TDM Multiconstituent Calibrator
Thermo Scientific QMS® TDM Multi-Constituent Calibrator
G. Regulatory Information:
1. Regulation section:
21 CFR § 862.3200; Clinical Toxicology Calibrator
2. Classification:
Class II
3. Product code:
DKB
4. Panel:
Toxicology (91)
H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
Abbott TDM Multiconstituent Calibrator
For in vitro diagnostic use in the calibration of the Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, 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
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MCC value sheet, packaged with the calibrator.
## Thermo Scientific QMS® 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, Valproic 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.
3. Special conditions for use statement(s):
- For in vitro diagnostic use
- For prescription use
4. Special instrument requirements:
- For use with the Architect c16000 System
## I. Device Description:
Both TDM Multi-Constituent Calibrator and QMS TDM Multi-Constituent Calibrator are identical calibrators and the only difference is the trade name. The calibrator set is sold separately and may be used with any reagent lot. The calibrators in this set are designed for use as a unit. Do not substitute or mix calibrators with those from other lots.
Each TDM and QMS Multiconstituent Calibrator set is packaged in a rectangular cardboard box with a 12-bottle divider, a product insert, and a value sheet. Kits are stored refrigerated at 2-8°C. TDM Multiconstituent Calibrator set is prepared from a bovine serum matrix and contains the following analytes (6 levels each): amikacin, carbamazepine, digoxin, gentamicin, phenobarbital, phenytoin, quinidine, theophylline, valproic acid, and vancomycin. Sodium azide at 0.09% and ProClin 300 at 0.1% are present as preservatives. TDM Multiconstituent Calibrator levels are provided in liquid ready to use form and can be stored at 2-8°C until the expiration date on the label. Once opened, the opened bottles are stable for 60 days when capped tightly and stored at 2-8°C.
## J. Substantial Equivalence Information:
1. Predicate device name(s):
CEDIA TDM Core Multi-cals
2. Predicate k number(s):
k961659
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3. Comparison with predicate:
Similarities and Differences
| Item | Candidate Devices | Predicate Device (k961659) |
| --- | --- | --- |
| Intended Use | For in vitro diagnostic use in the calibration of the Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin assays. | Same |
| Matrix | Bovine Serum | Same |
| Analytes | Amikacin
Carbamazepine
Digoxin
Gentamicin
Phenobarbital
Phenytoin
Quinidine
Theophylline
Valproic Acid
Vancomycin | Carbamazepine
Phenobarbital
Phenytoin
Theophylline
Valproic Acid |
| Stability | 24 months at 2-8°C. Open bottle stability of 60 days at 2-8°C and for 24 hours at 15-30°C | Closed vial up until expiration date; 30 days open vial stability |
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K. Standard/Guidance Document Referenced (if applicable):
None were referenced.
L. Test Principle:
Not applicable
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability:
Both TDM Multi-Constituent Calibrator and QMS TDM Multi-Constituent Calibrator are traceable to USP standards. The Primary Reference Standards were prepared by gravimetric additions of the United States Pharmacopeia (USP) grade drugs into a drug-free human serum pool. These materials were aliquot in single-use cryo vials, and stored at -70°C.
Stability:
Stability testing protocols and acceptance criteria were reviewed and found to be acceptable. Stability characteristics of the TDM and QMS TDM Multi-Constituent Calibrators were determined using accelerated (closed bottle) stability studies, real time (closed bottle) stability studies and real-time opened bottle stability studies. Based on the accelerated stress stability data, the shelf life claim is set for 24 months at 5°C. Real-time stability studies demonstrated a shelf life claim of 24 months at 2-8°C. Open bottle stability of 60 days was demonstrated at the recommended storage temperature (2-8°C) and for 24 hours at 15-30°C. Open vial and closed vial expiration dates are located in the package insert.
Value Assignment:
The values of the TDM Multi-Constituent Calibrators (TDM MCC) are assigned by generating calibration curve using internal Primary Reference Standards with their target values for each level of analyte. Assay controls were used to verify that control recoveries are within the published ranges to validate the calibration curve. Two lots of the TDM MCC were used and one lot of control were used in the value assignment procedure. TDM MCC Level 1 values are assigned to zero, since no drugs are present. The TDM MCC and the corresponding Primary Reference Standards were assayed on the Abbott
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Architect c16000. TDM MCC values were determined by ratio calculations of the assay recovery values of the TDM MCC and assay recovery values of the Primary Reference Standards. Calibration curves are generated using the TDM MCC with the new assigned values (shown in the table below).
| Analyte | TDM Multi-Constituent Target (μg/mL) | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | L1 | L2 | L3 | L4 | L5 | L6 |
| Amikacin | 0.0 | 2.92 | 9.59 | 19.75 | 33.98 | 50.71 |
| Carbamazepine | 0.0 | 1.86 | 3.76 | 7.68 | 11.64 | 18.64 |
| Digoxin | 0.0 | 0.49 | 0.96 | 1.89 | 2.74 | 4.57 |
| Gentamicin | 0.0 | 0.49 | 1.50 | 3.18 | 6.64 | 10.71 |
| Phenobarbital | 0.0 | 4.78 | 10.28 | 19.97 | 41.90 | 85.01 |
| Phenytoin | 0.0 | 2.50 | 5.27 | 10.41 | 20.82 | 41.40 |
| Quinidine | 0.0 | 0.43 | 1.03 | 1.93 | 3.71 | 7.40 |
| Theophylline | 0.0 | 2.91 | 5.64 | 11.28 | 21.81 | 43.28 |
| Valproic Acid | 0.0 | 14.16 | 25.43 | 52.27 | 100.56 | 151.63 |
| Vancomycin | 0.0 | 4.83 | 9.89 | 24.86 | 48.39 | 97.90 |
d. Detection limit: Not applicable
e. Analytical specificity: Not applicable
f. Assay cut-off: Not applicable
2. Comparison studies:
a. Method comparison with predicate device: Not applicable
b. Matrix comparison: Not applicable
3. Clinical studies:
a. Clinical Sensitivity: Not applicable
b. Clinical specificity: Not applicable
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c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
The values for each analyte are stated in the labeling.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
