Vital Diagnostics Serum Controls are assayed multi-analyte quality control material. Vital Diagnostics Serum Controls are 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. An assayed quality control material may be used for proficiency testing in inter laboratory surveys.
Device Story
Vital Diagnostics Serum Controls are lyophilized human serum-based quality control materials; supplemented with human/non-human enzymes, non-protein constituents, and bacteriostatic agents. Used in clinical chemistry laboratories to monitor test system precision and detect systematic analytical deviations caused by reagent or instrument variation. Provided in two levels per analyte; packaged in 5 mL glass amber bottles. Operators (laboratory technicians/clinicians) use the controls within an analytical test system; results are compared against assigned values provided in labeling to verify instrument performance. Benefits include ensuring accuracy and reliability of diagnostic assay results for patient testing.
Clinical Evidence
No clinical data. Bench testing only. Stability studies (real-time) support a 4-year shelf life at 2-8°C and open-vial stability of 7 days at 2-8°C or 31 days at -20°C. Traceability established via NIST SRMs and recognized reference methods.
Technological Characteristics
Lyophilized human serum matrix; contains human/non-human enzymes, non-protein constituents, and bacteriostatic agents. Two levels provided. Storage at 2-8°C. Traceable to NIST SRMs and established reference methods (e.g., CDC HDL-C reference method). Compatible with ATAC 8000 and ENVOY 500 analyzers (with specific TIBC exclusion for ENVOY 500).
Indications for Use
Indicated for use as an assayed multi-analyte quality control material in clinical laboratory test systems to estimate test precision and detect systematic analytical deviations arising from reagent or instrument variation. May be used for proficiency testing in inter-laboratory surveys.
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.
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k111063
B. Purpose for Submission:
New device
C. Measurand:
Quality control materials for the following analytes: Albumin, Calcium, Cholesterol, Creatinine, Direct Bilirubin, Iron, Glucose, Magnesium, Phosphorus, Total Bilirubin, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid, Alkaline Phosphatase, Amylase, HDL-Cholesterol, LDL-Cholesterol, Creatinine Kinase, g-Glutamyltransferase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Iron – Binding Capacity, Lactate Dehydrogenase, Potassium, Sodium, Chloride, Carbon Dioxide
D. Type of Test:
Not applicable
E. Applicant:
Vital Diagnostics, Inc.
F. Proprietary and Established Names:
Vital Serum Controls
G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660
2. Classification:
Class 1, reserved
3. Product code:
JJY
4. Panel:
75 Clinical chemistry
H. Intended Use:
1. Intended use(s):
Refer to indications for use below.
2. Indication(s) for use:
Vital Diagnostics Serum Controls are assayed multi-analyte control material.
Vital Diagnostics Serum Controls are 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. An assayed quality
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control material may be used for proficiency testing in inter laboratory surveys.
3. Special conditions for use statement(s):
For in vitro diagnostic use only. For prescription use.
4. Special instrument requirements:
The package insert lists the following instruments:
ATAC 8000 Analyzer
ENVOY 500 Analyzer with the exception of Total Iron – Binding Capacity (TIBC). TIBC is not intended for use on the ENVOY 500 analyzer.
I. Device Description:
Vital Diagnostics Serum Controls are lyophilized human serum to which human and non-human enzymes, non-protein constituents and bacteriostatic agents have been added. Two levels of control per analyte are provided. Each level is packaged into a glass amber bottle containing 5 mL of product. The product is packaged in multiple level boxes (6 x 5 mL) intended to be stored at 2 – 8 °C. The source material has been tested by FDA approved methods and found non reactive for Hepatitis B surface antigen, Hepatitis C and the antibody to HIV ½.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Randox Precision-Multi-Sera-Human, normal and elevated
2. Predicate 510(k) number(s):
k942458
3. Comparison with predicate:
| Comparison Table | | |
| --- | --- | --- |
| Characteristics | New Device (k111063) | Predicate (k942458) |
| Intended use | Intended for in vitro diagnostic use in the quality control of diagnostic assays | Same |
| Matrix | Human serum | Same |
| Form | Lyophilized | Same |
| Levels | Two | Same |
| Storage | 2-8°C | Same |
| Reconstituted stability | 7 days at -20°C | Same |
| Shelf Life | 36-48 months | 24 months |
| Analytes | Albumin, Calcium, Cholesterol, Creatinine, Direct Bilirubin, Iron, | Albumin, Calcium, Cholesterol, Creatinine, Direct Bilirubin, Iron, |
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| Comparison Table | | |
| --- | --- | --- |
| Characteristics | New Device (k111063) | Predicate (k942458) |
| | Glucose, Magnesium, Phosphorus, Total Bilirubin, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid, Alkaline Phosphatase, Amylase, HDL-Cholesterol, LDL-Cholesterol, Creatinine, Phosphokinase, g-Glutamyltransferase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Iron – Binding Capacity* (TIBC), Lactate Dehydrogenase, Potassium, Sodium, Chloride, Carbon Dioxide | Glucose, Magnesium, Phosphorus, Total Bilirubin, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid, Alkaline Phosphatase, Amylase, HDL-Cholesterol, LDL-Cholesterol, Creatinine Phosphokinase, g-Glutamyltransferase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Iron – Binding Capacity, Lactate Dehydrogenase, Potassium, Sodium, Chloride, Carbon Dioxide Cholinesterase, Lipase, Cortisol, Digoxin, Hydroxybutyrate, IgA, IgG, IgM, Lactate, Lithium, Acid Phosphatase, PSA, Salicylate, Thyroxin |
*TIBC is intended for use on the ATAC 800 analyzer only.
K. Standard/Guidance Document Referenced (if applicable):
Guidance for Industry and FDA Staff: Assayed and Unassayed Quality Control Material
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):
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Controls are traceable to the reference material shown in the table below:
| Traceability: Reference material | |
| --- | --- |
| Albumin | NIST SRM 927/CRM 470 |
| Calcium | NIST SRM 915b |
| Cholesterol | NIST SRM 911c/909b/1952a |
| Creatinine | NIST SRM 967b |
| Direct Bilirubin | Roche Calibrator for Automated Systems |
| Glucose | NIST SRM 917b |
| Iron | NIST SRM 937 |
| Magnesium | NIST SRM 3131a |
| Phosphorus | NIST SRM 3139a now available |
| Total Bilirubin | NIST SRM 916a |
| Total Protein | NIST SRM 927 |
| Triglycerides | NIST SRM 1951b / 909b |
| Urea Nitrogen | NIST SRM 912a |
| Uric Acid | NIST SRM 913a, SRM 909b |
| Alkaline Phosphatase | Extinction coefficient of 4 nitrophenol at 405nm / ε= 18.45 |
| Amylase | Extinction coefficient of 2-chloro-4-nitrophenol at 405 nm /ε = 15.0 |
| HDL, Cholesterol | CDC HDL-C Reference Method |
| LDL, Cholesterol | National Reference System for Cholesterol |
| Creatine Kinase | Extinction coefficient of NADH at 340nm /ε = 6.3 |
| γ-Glutamyltransferase | Extinction coefficient of 5-amino-2-nitrobenzoate at 405 nm / ε = 9.5 |
| Aspartate Aminotransferase | Extinction coefficient of NADH at 340nm /ε = 6.3 |
| Alanine Aminotransferase | Extinction coefficient of NADH at 340nm /ε = 6.3 |
| Total Iron Binding Capacity* (TIBC) | NIST SRM 937 |
| Lactate Dehydrogenase | Extinction coefficient of NADH at 340nm /ε = 6.3 |
| Potassium | NIST SRM 918 |
| Sodium | NIST SRM 919 |
| Chloride | NIST SRM 918/919 |
| Carbon Dioxide | SRM 351a ACS Sodium Carbonate Standard |
*TIBC is intended for use on the ATAC 800 analyzer only.
## Value assignment:
Expected values are determined using selected commercially available reference materials/standards and at least five vials of candidate control materials, two analyzers per each analyzer type, and two lots of reagents. The target value for each analyte is the mean of the observed 16 replicates. Control assigned values are lot dependent and are listed in the labeling. The mean and ranges are provided in tabular form in the value assignment sheets.
## Stability:
Shelf-Life and Open Vial Stability testing protocols and acceptance criteria were described and found to be adequate.
Shelf-Life – The sponsor provided real time stability data to support data
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demonstrating that the Vital Diagnostics Serum Controls can be stored for 4 years at 2-8 °C.
Open-vial – The sponsor provided data demonstrating that upon opening a vial, the material is stable for 7 days at 2-8 °C and 31 days -20°C.
**Value Assignment:**
Instruments used for the value assignment included ATAC 8000 and ENVOY 500 analyzers.
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):
Not applicable
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4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Expected values are provided in the value assignment sheets provided with the package insert
N. Proposed Labeling:
The labeling is sufficient and 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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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.
