Mission Trinity R™ Control is intended to be used as an assayed quality control material for monitoring the precision and performance of the following analytes pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, and lactate on blood gas, electrolyte, and metabolite analyzers as well as tHb, %O2Hb, %O2Sat, %COHb, %MetHb, %O2Ct & %HHb on CO-Oximeter instrumentation. It is for in vitro diagnostics use and for the quantitative determination of the analytes listed on the Expected Values Chart.
Device Story
Mission Trinity R is an assayed quality control material; consists of buffered aqueous solution containing electrolytes, glucose, lactate, dyes, and preservatives; equilibrated with CO₂, O₂, and N₂ gases. Provided in three levels in sealed 1.8 mL glass ampules. Used by laboratory personnel on Radiometer and Ciba-Corning/Bayer blood gas, electrolyte, metabolite, and CO-oximeter analyzers. Functions as a reference standard to monitor instrument precision; healthcare providers compare analyzer results against assigned control values to verify system performance and ensure clinical accuracy of patient diagnostic testing.
Clinical Evidence
No clinical data. Bench testing only. Stability (real-time, shelf-life, open-vial, transport) and value assignment protocols were validated. Traceability established using NIST-traceable standards for electrolytes and glucose.
Technological Characteristics
Buffered aqueous solution containing electrolytes, glucose, lactate, dyes, and preservatives. Equilibrated with CO₂, O₂, and N₂. Packaged in 1.8 mL sealed glass ampules. Storage at 2-8°C. Non-biological matrix. No electronic or software components.
Indications for Use
Indicated for use as an assayed quality control material for monitoring the precision and performance of blood gas, electrolyte, metabolite, and CO-Oximeter analyzers. No specific patient population is described as the device is a laboratory quality control material.
Regulatory Classification
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Predicate Devices
RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control (k880447)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k093384
B. Purpose for Submission:
New Device
C. Measurand:
Quality Control material for pH, pCO₂, pO₂, Na⁺, K⁺, Ca²⁺, Cl⁻, glucose, lactate, tHb, %COHb, %metHb and %HHb
D. Type of Test:
Not applicable
E. Applicant:
Diamond Diagnostics, Inc.
F. Proprietary and Established Names:
Mission Trinity R (Level 1, 2, 3)
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY | Class I | 21 CFR 862.1660 | Chemistry 75 |
H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
Mission Trinity R Control is intended to be used as an assayed quality control material for monitoring the precision performance of the following analytes pH, pCO₂, pO₂,
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Na⁺, K⁺, Ca²⁺, Cl⁻, glucose and lactate on blood gas, electrolyte and metabolite analyzers as well as tHb, %O₂Hb, %O₂Sat, %COHb, %MetHb, %O₂Ct & %HHb on CO-oximeter instrumentation.
3. Special conditions for use statement(s):
Prescription use only
4. Special instrument requirements:
Radiometer ABL Blood Gas analyzers and CO-oximeters, Radiometer OSM3 CO-oximeter, Ciba-Corning/Bayer Blood Gas analyzers
I. Device Description:
Trinity R consists of a buffered solution of electrolytes, glucose, lactate, dyes and preservative. It is equilibrated with specific levels of CO₂, O₂, and N₂. It contains no human or biological materials.
Trinity R is provided in three distinct levels of pH, pCO₂, pO₂, Na⁺, K⁺, Ca²⁺, Cl⁻, glucose, lactate, tHb, %O₂Hb, %HbO₂Sat, %COHb, %MetHb, %O₂Ct & %HHb covering the significant range of the instrument performance. It is packaged in sealed glass ampules, each containing 1.8 ml of solution. Ampules are packaged in single level boxes (30 ampules of same level) or tri-level boxes (10 ampules of each level). The ampules are single use products.
J. Substantial Equivalence Information:
1. Predicate device name:
RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter (Radiometer) Control
2. Predicate K number:
k880447
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| | Candidate Device | Predicate Device |
| Characteristics | Mission Trinity R | RA525 (k880447) |
| Intended Use | For in vitro diagnostics use for quality control of pH/Blood Gas analyzers, | Same |
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| | ISE analyzers, Metabolite analyzers and CO-Oximeter instrumentation. | |
| --- | --- | --- |
| Product Type | Assayed Blood Gas Control | Same |
| Matrix | Buffered Aqueous Solution | Same |
| Storage | 2-8°C | Same |
| Color | Red/purple solution | Same |
| Levels | Three | Same |
| Analytes | pH, pCO₂, pO₂, Na⁺, K⁺, Ca++, Cl⁻, glucose, lactate, tHb, %O₂Hb, %COHb, %metHb, %O₂Ct, %O₂Sat and %HHb | Same |
| Instruments | Multiple instruments | Multiple instruments |
| Differences | | |
| --- | --- | --- |
| | Candidate Device | Predicate Device |
| Characteristics | Mission Trinity R | RA 525 (predicate k880447) |
| Preservative | Present | Not present |
| Package | Package 30 x 1.8mL | 30 x 2.5mL |
| Shelf Life | 24 months | 36 months |
K. Standard/Guidance Document Referenced (if applicable):
FDA Guidance for Industry and FDA Staff: Assayed and Unassayed Quality Control Materials
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
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c. Traceability, Stability, Expected values (controls, calibrators, or methods):
# Traceability
Commercially available salts/chemical constituents are gravimetrically weighed and added to deionized water to yield desired concentrations. Controls are tonometered with commercially available gas to yield the desired pH, $\mathrm{pCO_2}$ , $\mathrm{pO_2}$ , levels for each control. Commercially available dyes are also added to create clinically relevant co-oximeter values for each control. Lot to lot variation of the Mission Trinity R controls is determined by testing the new lot vs. the previous lot normalized to either an aqueous standard made with corresponding analyte NIST material or a known calibrator.
| Analyte | Standard Used for Determination of Analyte Value |
| --- | --- |
| Na, K | NIST 919a, 918a |
| Ca | NIST 915a |
| Cl | NIST 919a |
| Glucose | NIST 917b |
| Lactate | Pointe™ Lactate Std |
# Value Assignment
Multiple replicates of test samples are measured at the beginning and end of the production run on various analyzers for electrolyte, metabolite, and co-oximetry values. Multiple replicates of test samples are run on two analyzers for blood gas and pH values. Values are determined by taking the mean of multiple determinations performed on randomly selected samples from each lot. Ranges are assigned using pre-determined intervals. Value assignment is performed for each lot of Mission Trinity R control.
The labeling states that laboratories should establish appropriate acceptance criteria when using this product for its intended use.
# Stability
Real Time, Shelf-Life, Open Vial, and Transport Simulation testing protocols and acceptance criteria were described and found to be adequate. The Mission Trinity R controls are stable until the expiration date of two years printed on the vials when stored at $2 - 8^{\circ}\mathrm{C}$ . The labeling states that for $\mathsf{pH}$ and blood gas values the controls should be analyzed within one minute of opening and for electrolyte measurements the controls should be analyzed within one hour of opening. This device should not be frozen.
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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
c. Other clinical supportive data (when a. and b. are not applicable):
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
The expected values are provided in the labeling for each specific lot.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
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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.
