This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
Device Story
DOCUMENT™ TDM ULTRA Assayed Control is a liquid human serum matrix containing 25 analytes; used as a quality control material for automated and semi-automated immunochemistry and clinical chemistry systems. The device provides a stable, ready-to-use control to assess analytical performance, monitor accuracy/precision, and assist in troubleshooting system, reagent, or calibration issues. It is used by laboratory personnel in clinical settings to verify that diagnostic systems are functioning within expected parameters for the listed therapeutic drugs, thyroid hormones, and ethanol.
Clinical Evidence
Bench testing only. Equivalence established by comparing inter-assay precision of the 25 analytes in the DOCUMENT™ TDM ULTRA Assayed Control against the performance of the three predicate devices. Results indicate the subject device behaves in a similar manner to the predicates and is suitable for use as a control for the listed analytes.
Technological Characteristics
Liquid human serum matrix; contains 25 analytes; provided in three levels (I, II, III); packaged in plastic containers with dropper tips; ready-to-use (no dilution required); 30-day open-vial stability.
Indications for Use
Indicated for use as an in vitro diagnostic control material to assess the analytical performance of immunochemistry and clinical chemistry systems for the quantitative measurement of 25 analytes: acetaminophen, amikacin, carbamazepine, digoxin, disopyramide, ethanol, ethosuximide, gentamicin, lidocaine, methotrexate, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, thyroid-stimulating hormone, thyroxine, tobramycin, triiodothyronine, T-Uptake, valproic acid, and vancomycin.
Regulatory Classification
Identification
A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
Predicate Devices
Dade Immunoassay Controls Comprehensive Tri-Level, Levels 1, 2, and 3
Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls, Low and High Levels
Abbott REA Ethanol Serum Control, Levels L, M, and H
Submission Summary (Full Text)
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K96C344 MAR 22 13:51
Exhibit 15. 510(k) Summary
FEDERAL FOOD, DRUG AND COSMETIC ACT
510(k) SUMMARY
DOCUMENT™ TDM ULTRA Assayed Control, Levels I, II, III
1. Submitted by: CASCO Standards
P.O. Box 970
Yarmouth, ME 04096
Attention: Christine V. Beach
Manager, Regulatory Affairs
(207) 878-7550
(207) 878-7578 FAX
January 5, 1996
2. Product Name:
Proprietary Name: DOCUMENT™ TDM ULTRA Assayed Control
Classification Name: Control, multiple analyte, assayed.
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# 3. Predicate Device:
Product: Dade Immunoassay Controls Comprehensive Tri-Level, Levels 1, 2, and 3
Catalog: Level 1 (B5700-6), Level 2 (B5700-7), Level 3 (B5700-8)
Manufacturer: BaxterDiagnostics, Inc., Deerfield, IL 60015-4633
Analytes: ACET, AMI, CARB, DIG, DISO, ETHO, GENT, LIDO, NAPA, PHENO, PHENY, PRIM, PROC, QUIN, SAL, THEO, hTSH, T4, TOB, T3, TU, VAL
Product: Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls, Low and High Levels
Catalog: Low (2841-31), High (2842-31)
Manufacturer: Instrumentation Laboratory Company, Lexington, MA 02173-3190
Analytes: METH, VANCO
Product: Abbott REA Ethanol Serum Control, Levels L, M, and H
Catalog: 9545-11
Manufacturer: Abbott Laboratories, Abbott Park, IL 60064
Analytes: ETOH
# 4. Product Description:
**DOCUMENT® TDM ULTRA Assayed Controls** consist of three levels of a human serum matrix containing 25 commonly monitored analytes. The formulation design provides a liquid matrix intended for use on automated and semi-automated immunochemistry systems and clinical chemistry systems for the determination of blood acetaminophen (ACET), amikacin (AMI), carbamazepine (CARB), digoxin (DIG), disopyramide (DISO), ethanol (ETOH), ethosuximide (ETHO), gentamicin (GENT), lidocaine (LIDO), methotrexate (METH), N-acetylprocainamide (NAPA), phenobarbital (PHENO), phenytoin (PHENY), primidone (PRIM), procainamide (PROC), quinidine (QUIN), salicylate (SAL), theophylline (THEO), thyroid-stimulating hormone (hTSH), thyroxine (T4), tobramycin (TOB), triiodothyronine (T3), T-Uptake (TU), valproic acid (VAL), and vancomycin (VANCO).
# 5. Intended Use:
This product is intended for *in vitro* diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
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6. Comparison to the Predicate Device:
| Characteristic | DOCUMENT®
TDM ULTRA
Assayed Control | Dade
Immunoassay
Comprehensive
Tri-Level Control | Instrumentation
Laboratories
TheraChem TDC
Therapeutic Drug
Control | Abbott REA
Ethanol Serum
Control |
| --- | --- | --- | --- | --- |
| Intended Use | To assess the analytical performance of analytical systems in the quantitative measurement of therapeutic drugs, thyroid function, and ethanol | Assist in monitoring accuracy and precision in clinical assays | Control material for procedures used to quantitate levels of therapeutic drugs and thyroid hormones in serum specimens | Controls for the validation of calibration of the REA Ethanol assay on the TDxFLx, TDx, or ADx |
| Number of Levels | Three (3):
Level I, Level II
Level III | Three (3):
Level 1, Level 2,
Level 3 | Two (2):
Low, High | Three (3):
L, M, H |
| Type | Assayed | Assayed | Assayed | Assayed |
| Analytes | 25 | 64 | 30 | 1 |
| Volume | 5 mL | 5 mL | 5 mL | 4 mL |
| Matrix | Human serum,
Liquid | Human source,
Lyophilized | Bovine serum,
Lyophilized | Human blood components,
Liquid |
| Dilution | None required | None required | None required | None required |
| Unopened Stability | Until Expiration Date | Until Expiration Date | Until Expiration Date | Until Expiration Date |
| Open Stability | 30 Days | Varies with analyte following reconstitution | Up to four weeks after reconstitution | Until expiration date |
| Container | Plastic,
Dropper Tip | Glass | Glass | Plastic |
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# 7. Test Results:
The equivalence for this product was carried out by comparing the inter-assay precision of the listed analytes of the **DOCUMENT™** TDM ULTRA Assayed Control to that of Dade Immunoassay Controls Comprehensive Tri-Level, Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls and Abbott REA Ethanol Serum Control. The results show that the **DOCUMENT™** TDM ULTRA Assayed Control behaves in a similar manner compared to the predicate devices and is suitable for use as a control for the listed analytes.
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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.
