K033063 · Diamond Diagnostics, Inc. · JJS · Dec 12, 2003 · Clinical Chemistry
Device Facts
Record ID
K033063
Device Name
MISSION CONTROLS
Applicant
Diamond Diagnostics, Inc.
Product Code
JJS · Clinical Chemistry
Decision Date
Dec 12, 2003
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1660
Device Class
Class 1
Indications for Use
The Mission Diagnostic controls are 4 levels of assayed quality control materials intended for monitoring the measurements of pH, pCO2, PO2 in blood gas analyzers and sodium, potassium, chloride, lithium, ionized calcium and total CO2 in pH/blood gas and or electrolyte analyzers. They are intended to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation. Ranges are provided for six test systems; AVL, Ciba-Corning (now Bayer), IL, NOVA, Radiometer, and Medica analyzers. (Specific models of these analyzers appear on the Indications for Use form.) The device is for in vitro diagnostic use. The device is for prescription use.
Device Story
Mission Diagnostic ISE pH/Blood Gas Controls are 4-level aqueous-based control materials. Used in clinical settings to monitor performance of blood gas and electrolyte analyzers (AVL, Corning/Bayer, Radiometer, Medica, IL, NOVA). Controls are prepared by gravimetrically weighing salts into Type 1 deionized water and tonometering with gas to achieve target pH, pCO2, and pO2 levels. Healthcare providers run these controls on analyzers to estimate test imprecision and detect systematic deviations caused by instrument or reagent variation. Value assignment involves comparing the subject material and a predicate device against a reference point on at least two instruments; the determined bias is applied to the predicate's analyte ranges. This process ensures the controls provide reliable target ranges for quality assurance, helping clinicians verify the accuracy of patient diagnostic testing.
Clinical Evidence
No clinical data. Bench testing only. Stability studies conducted per SOP23-01-03 support a 3-year shelf life.
Technological Characteristics
Aqueous-based tonometered control material. Formulated for pH/Blood Gas and Electrolyte analyzers. No specific materials of construction or software algorithms described; device is a chemical control reagent.
Indications for Use
Indicated for use as quality control material for pH/Blood Gas and Electrolyte analyzers to monitor test imprecision and detect systematic deviations in clinical laboratory settings. Levels 1, 2, and 3 cover low, mid, and high clinical ranges; Level 4 monitors high O2 levels.
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.
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
k033063
B. Analyte:
pH, PCO2, PO2, Sodium, Potassium, Calcium, Chloride, Lithium
C. Type of Test:
Control materials for blood gas instruments
D. Applicant:
Diamond Diagnostics, Inc.
Mission Diagnostics is a Division of Diamond Diagnostics
E. Proprietary and Established Names:
Mission Diagnostic ISE pH/Blood Gas Controls for pH/BG &/or Electrolyte Analyzers
F. Regulatory Information:
1. Regulation section:
862.1660, Controls, Assayed and Unassayed
2. Classification:
I
3. Product Code:
JJS
4. Panel:
Chemistry (75)
G. Intended Use:
1. Intended use(s):
Refer to Indications for use.
2. Indication(s) for use:
The Mission Diagnostic controls are 4 levels of assayed quality control materials intended for monitoring the measurements of pH, pCO2, PO2 in blood gas analyzers and sodium, potassium, chloride, lithium, ionized calcium and total CO2 in pH/blood gas and or electrolyte analyzers. They are intended to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation. Ranges are provided for six test systems; AVL, Ciba-Corning (now Bayer), IL, NOVA, Radiometer, and
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Medica analyzers. (Specific models of these analyzers appear on the Indications for Use form.)
The device is for in vitro diagnostic use.
The device is for prescription use.
3. Special condition for use statement(s):
None.
4. Special instrument Requirements:
Not applicable.
## H. Device Description:
The product is a four level aqueous based control material.
## I. Substantial Equivalence Information:
1. Predicate device name(s):
ALKOnTrol Controls
2. Predicate K number(s):
k950902
3. Comparison with predicate:
Both devices are aqueous based control materials with similar constituents and have the same intended use. The manufacturers differ.
## J. Standard/Guidance Document Referenced (if applicable):
The sponsor did not reference any standards in their submission.
## K. Test Principle:
Not applicable.
## L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable.
b. Linearity/assay reportable range:
Not applicable.
c. Traceability (controls, calibrators, or method):
The appropriate salts (chemical constituents) are gravimetrically weighed out and added to Type 1 deionized water to yield the desired control values. The controls are tonometered with the appropriate gas to yield the desired pH, pCO2, and pO2 levels for each control.
Representative value assignment sheets for each level are provided.
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## Value Assignment Procedures:
The sponsor does not establish their own ranges for each of the analyzers identified in their value assignment sheet. Instead, they analyze their material and the predicate device on a minimum of 2 analyzers. They establish the bias between the two materials by comparing both of them to a reference point. The determined bias is then applied to all of the analyte ranges posted by the predicate device.
Controls are run on a flame photometer for Na, K, and Li and via an ISE measurement for Ca, Cl, and TCO2.
According to the sponsor, values are established by running on a minimum of two instruments in the AVL, Corning/Bayer, Radiometer, and Medica Instrument families.
Currently, the sponsor is able to utilize the following instrument models in their testing:
- AVL - Compact 2, 995, 985, 9180, 9130
- Corning – 238, 248, 865, 278, 288, 664, 634,614, 654
- Radiometer – 520
- MEDICA – EASYLyte Na/K/Cl/Li, Na/K/Ca/pH, ILyte Na/K/Cl
## Stability Studies:
Stability of the products has not yet been established, however studies are currently under way. The sponsor states the firm is targeting a three year shelf life. Stability of the product is being established on 1 lot of product in an accelerated study and is being confirmed on 3 lots of product via real time studies. Stability testing will not be performed on future lots.
Accelerated studies are based on the 2X rule. The sponsor is evaluating 20 weeks at 55°C in order to project a 3 year stability claim.
## Conditions of the study include:
- Storage temperatures are RmT (25°C) & 55°C.
- Frequency of testing is every 3 wks for 55°C for the accelerated studies and every 12 wks for RmT for the Real Time studies.
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The reference values against which measurements are compared are as follows:
For Na, K, Cl, Ca, Li, TCO2 testing is NIST standard measurements.
- At each Accelerated time point the difference between Accelerated and RmT values are calculated.
- At each Real Time point, values are compared to T=0 (the initially measured value).
For pH, pCO2, pO2 a minimum of 3 ampules per temperature are tested.
- At each Accelerated time point difference between Accelerated and RmT value is calculated.
- At each Real Time point, difference between the new lot and predicate device is calculated and compared to the Time =0 bias value.
Acceptance Criteria for the study for Na, K, Cl, Ca, Li, TCO2 is ± 2, 0.05, 3, 0.03, 0.03, 2 respectively.
For pH, pCO2, pO2 the criteria is ± 0.005, 3, 5 respectively.
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:
Representative target ranges for the control have been provided.
**M. Conclusion:**
I recommend that this device be found substantially equivalent to the predicate device.
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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
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.
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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.
