K062674 · Diamond Diagnostics, Inc. · JJY · Dec 1, 2006 · Clinical Chemistry
Device Facts
Record ID
K062674
Device Name
MISSION TRINITY B
Applicant
Diamond Diagnostics, Inc.
Product Code
JJY · Clinical Chemistry
Decision Date
Dec 1, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1660
Device Class
Class 1
Indications for Use
Mission Trinity B™ Controls are intended to be used as a quality control material for monitoring the performance of pH, PCO2, PO2, Na+, Ca++, Cl-, glucose, lactate, tHb, % O2Hb, % CoHb, % metHb & % HHb on Bayer instrumentation.
Device Story
Mission Trinity B™ Controls are a three-level aqueous quality control material used to monitor the performance of Bayer blood gas, electrolyte, metabolite, and CO-Oximetry analyzers. The solution contains buffers, electrolytes, glucose, lactate, and dyes, equilibrated with CO2, O2, and N2. It is packaged in sealed glass ampules. The control is used by laboratory personnel to verify that the analyzer is operating within established performance ranges. By measuring the control material, the healthcare provider assesses the accuracy and precision of the instrument's analytical results, ensuring reliable diagnostic data for patient care.
Clinical Evidence
No clinical data. Performance verified via bench testing, including accelerated high-temperature stress tests for stability and side-by-side comparative testing against the predicate device on intended instrumentation.
Technological Characteristics
Aqueous solution of buffers, electrolytes, glucose, lactate, and dyes; equilibrated with CO2, O2, and N2. Form factor: 1.8mL glass ampule (heat-sealed, score-break). Storage: 2-8°C or 18-25°C. Contains no human or animal materials. Standalone control material; no software or connectivity.
Indications for Use
Indicated for use as an assayed quality control material for monitoring the performance of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb, and %HHb on Bayer blood gas, electrolyte, metabolite, and CO-Oximetry analyzers. For in vitro diagnostic use.
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
Bayer Rapid QC™Complete
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k062674
B. Purpose for Submission:
New Device
C. Measurand:
Quality control material for pH, PCO2, PO2, Na+, K+, Ca++, 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 B™ Controls
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| Multi-Analyte Controls, All Kinds (Assayed and Unassayed) JJY | Class I | 21 CFR 862.1660 | 75 Clinical Chemistry (CH) |
H. Intended Use:
1. Intended use(s):
See indications(s) for use below.
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2. Indication(s) for use:
Mission Trinity B™ Controls are intended to be used as a quality control material for monitoring the performance of pH, PCO2, PO2, Na+, Ca++, Cl-, glucose, lactate, tHb, % O2Hb, % CoHb, % metHb & % HHb on Bayer instrumentation.
3. Special conditions for use statement(s):
For prescription use
4. Special instrument requirements:
Bayer 270/800/400 Analyzer Series Instrumentation
I. Device Description:
Mission Trinity B™ Controls are a specially formulated, three-level, aqueous material intended for use to monitor all analytes measured by the Bayer line of blood gas, electrolyte, metabolite and CO-Oximetry analyzers. This control material is provided in three (3) distinct levels of pH, pCO2, PO2, Na+, K+, Cl-, Ca++, glucose, lactate, tHb, O2Hb, COHb, metHb, and HHb covering the significant range of the instrument performance. It is packaged in sealed glass ampules, each containing 1.8 mL of solution.
J. Substantial Equivalence Information:
| Characteristics | Mission Trinity B (New Device k062674) | Bayer Rapid QC™Complete |
| --- | --- | --- |
| PN | DD-96001, 96002, 96003, 96123 | 108860, 108868, 108869 |
| Contents: Any Level | Aqueous solution of buffers, electrolytes, glucose lactate dyes, equilibrated with CO2, O2and N2. Contains NO human or animal materials. | Aqueous solution of buffers, electrolytes, glucose lactate dyes, equilibrated with CO2, O2and N2. Contains NO human or animal materials. |
| Container | Glass ampule (heat sealed, score break) | Glass ampule (heat sealed, score break) |
| Color | Red/ purple solution | Red/ purple solution |
| Package | 30 X 1.8 mL (instrument only requires a fraction of an mL to make measurement | 30 X 2.5 mL |
| Intended Use | For in-vitro diagnostics use for quality control of pH, Blood Gas analyzers, ISE analyzers, CO-oximeters, and Metabolite Analyzers. | For in-vitro diagnostics use for quality control of pH, Blood Gas analyzers, ISE analyzers, CO-oximeters, and Metabolite Analyzers. |
| Storage/ Shelf Life | 2-8°C (36-months) or 18-25°C 12 - months | 2-8°C (36 months) or 18-25°C (until expiration date) |
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# K. Standard/Guidance Document Referenced (if applicable):
Not Applicable
# 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: The assigned values for the Mission Trinity Control were derived from formulated pilot lots of levels 1, 2, and 3 matching the Bayer Complete (OEM) Controls as close as possible. The bias with the predicate's assay sheet is taken into account. The established ranges are $\pm 10\%$ with some exceptions such as CO-OX fractions. The Mission Trinity Control test pilot lots and Bayer Complete were assayed on the Bayer 855 analyzer for comparison. The results are presented in the table below.
| Analyte | Units | Level 1 | | Level 2 | | Level 3 | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | OEM | Pilot | OEM | Pilot | OEM | Pilot |
| pH | --- | 7.16 | 7.16 | 7.36 | 7.36 | 7.57 | 7.65 |
| pCO2 | mmHg | 73 | 61 | 43 | 42 | 23 | 23.4 |
| pO2 | mmHg | 142 | 156 | 99 | 106 | 29 | 17 |
| Na+ | mmol/L | 112 | 116 | 134 | 139 | 157 | 154 |
| K+ | mmol/L | 3.14 | 2.73 | 4.87 | 4.15 | 6.96 | 6.32 |
| Cl- | mmol/L | 72 | 74 | 96 | 93 | 120 | 112 |
| iCa | mmol/L | 1.61 | 1.4 | 1.16 | 0.85 | 0.76 | 0.34 |
| tHb | g/dL | 16 | 18.6 | 12.7 | 11.9 | 7.8 | 6.7 |
| O2Hb | % | 77.5 | 81.2 | 90.4 | 91.1 | 58.5 | 57 |
| COHb | % | 4.4 | 1.6 | 6.3 | 6.6 | 20.9 | 21.5 |
| MetHb | % | 15.5 | 14.3 | 1.5 | 1.4 | 6.3 | 5.4 |
| HHb | % | 2.6 | 2.9 | 1.8 | 1.0 | 15.4 | 16 |
| Glucose | mg/dL | 206 | 200 | 99 | 107 | 50 | 55 |
| Lactate | mmol/L | 12.3 | 12.3 | 0.91 | 0.90 | 3.00 | 3.00 |
| Na+ | mmol/L | 1.1 | 1.1 | 0.9 | 0.9 | 0.9 | 0.9 |
| K+ | mmol/L | 1.1 | 1.1 | 0.9 | 0.9 | 0.9 | 0.9 |
| Cl- | mmol/L | 1.1 | 1.1 | 0.9 | 0.9 | 0.9 | 0.9 |
| iCa | mmol/L | 1.1 | 1.1 | 0.9 | 0.9 | 0.9 | 0.9 |
| tHb | g/dL | 16 | 18.6 | 12.7 | 11.9 | 7.8 | 6.7 |
| O2Hb | % | 77.5 | 81.2 | 90.4 | 91.1 | 58.5 | 57 |
| COHb | % | 4.4 | 1.6 | 6.3 | 6.6 | 20.9 | 21.5 |
| MetHb | % | 15.5 | 14.3 | 1.5 | 1.4 | 6.3 | 5.4 |
| HHb | % | 2.6 | 2.9 | 1.8 | 1.0 | 15.4 | 16 |
| Glucose | mg/dL | 206 | 200 | 99 | 107 | 50 | 55 |
| Lactate | mmol/L | 12.3 | 12.3 | 0.91 | 0.90 | 3.00 | 3.00 |
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Stability: The sponsor performed an accelerated stability study of the Mission Trinity B Controls stored refrigerated at (2-8°C) for 36-months, and also 12-months stability when stored at room temperature (18-25°C). Real time stability studies are on-going.
The sponsor’s stability study demonstrated that the Mission Trinity Controls are stable up to 12 months when stored at 18-25°C or 36 months when stored at 2-8°C.
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):
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4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
The expected mean and ranges are provided in the labeling. The sponsor recommends in the labeling that the expected ranges are provided as a guide in evaluating analyzer performance and that each laboratory should establish its own acceptance criteria for the control materials.
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 equivalent decision.
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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
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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.
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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.
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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.
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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.
