DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
Applicant
Dade Behring, Inc.
Product Code
JJY · Clinical Chemistry
Decision Date
Sep 11, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1660
Device Class
Class 1
Indications for Use
PROT1 Cal is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: α₁-acid glycoprotein, α₁ antitrypsin, β₂-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin. PROT1 CON L is an assayed, low level, intra-laboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: α₁-acid glycoprotein, α₁ antitrypsin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin. PROT1 CON M and H are assayed, mid- and high level, intra-laboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: α₁-acid glycoprotein, α₁-antitrypsin, β₂-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.
Device Story
Multi-analyte, liquid, human serum-based calibrator and quality control materials; used for calibration and assessment of precision/analytical bias on the Dimension Vista System; contains sodium azide preservative; provides reference values for specific proteins including hemopexin, IgG subclasses, and retinol binding protein; used by laboratory personnel in clinical settings to ensure accuracy of automated turbidimetric immunoassays.
Clinical Evidence
No clinical data. Bench testing only. Stability studies conducted over 24 months; value assignment validated against ERM-DA470 and highly purified protein preparations.
Technological Characteristics
Liquid, human serum-based multi-analyte products. Calibrator and controls are designed for use on the Dimension Vista System. No specific materials or software algorithms described for the calibrator/control products themselves.
Indications for Use
Indicated for use as calibrators and quality control materials for the quantitative determination of specific proteins on the Dade Behring Dimension Vista System. For prescription use only.
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
Dimension Vista® Protein 1 Calibrator and Protein 1 Control L, M, and H (k063663)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
A. 510(k) Number:
k071980
B. Purpose for Submission:
Add additional analytes to existing multi-analyte calibrator and controls
C. Measurand:
New analytes added: Hemopexin (HPX), immunoglobulin IgG subclasses (IgG1, IgG2, IgG3 and IgG4), and retinol binding protein
D. Type of Test:
Calibrator and controls for an automated turbidimetric immunoassay
E. Applicant:
Dade Behring
F. Proprietary and Established Names:
Dade Behring Dimension Vista® Protein 1 Calibrator (Prot1 Cal) and Dimension Vista® Protein 1 Control L, M, and H (Prot1 control L, M, or H)
G. Regulatory Information:
1. Regulation section:
CFR 862.1150 Calibrator
CFR 862.1660 Quality control materials (assayed and unassayed)
2. Classification:
Calibrator: Class II
Controls: Class I
3. Product code:
JIX Calibrator, multi-analyte mixture
JJY Multi-analyte controls, all kinds (assayed and unassayed)
4. Panel:
Clinical Chemistry (75)
H. Intended Use:
1. Intended use(s):
PROT1 Cal is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: α₁-acid glycoprotein, α₁ antitrypsin, β₂-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.
PROT1 CON L is an assayed, low level, intra-laboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: α₁-acid glycoprotein, α₁ antitrypsin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.
PROT1 CON M and H are assayed, mid- and high level, intra-laboratory quality
{1}
controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: $\alpha_{1}$-acid glycoprotein, $\alpha_{1}$-antitrypsin, $\beta_{2}$-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.
2. Indication(s) for use:
Same as the Intended Uses
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
Dade Behring Dimension Vista System
I. Device Description:
PROT1 CAL is a multi-analyte, liquid, human serum based product containing: $\alpha_{1}$-acid glycoprotein, $\alpha_{1}$-antitrypsin, $\beta_{2}$-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin. It is ready to use and contains sodium azide (<0.1%) as a preservative.
PROT1 CON L, M, or H are multi-analyte, liquid, human serum based product containing: $\alpha_{1}$-acid glycoprotein, $\alpha_{1}$-antitrypsin, $\beta_{2}$-microglobulin (PROT1 CON M and H only), C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin. These reagents are ready to use and contain sodium azide (<0.1%) as a preservative.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Dimension Vista® Protein 1 Calibrator and Protein 1 Control L, M, and H
2. Predicate K number(s):
k063663
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | 1) Calibration of the Dimension Vista System 2) Assessment of precision and analytical bias | Same |
| Matrix | Liquid, human serum | Same |
| Levels | 1 calibrator level
3 control levels | Same |
| Preservative | Sodium azide | Same |
| Source material | Homocysteine – purified S-adenosylhomocysteine; All other analytes – human | Same |
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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | Addition of **hemopexin**, **IgG subclasses (IgG1, IgG2, IgG3, and IgG4)**, **IgM**, **retinol binding protein** to predicate list of analytes. | α_{1}-acid glycoprotein, α_{1}-antitrypsin, β_{2}-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, homocysteine, IgA, IgE, IgG, IgM, prealbumin, soluble transferrin receptor, and transferrin |
K. Standard/Guidance Document Referenced (if applicable):
None referenced
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 of Added Constituents:
| Analyte | Traceability to: |
| --- | --- |
| IgG subclasses (IgG1, IgG2, IgG3, and IgG4) | ERM-DA470 (CRM 470) |
| Hemopexin, retinol binding protein | Highly purified protein |
Stability:
The calibrators and controls follow the same stability protocol. Products are stored at 2-8° C and the stability studies are conducted for 24 months using 3 vials and 3 replicates per vial. Testing cycles are 0, 12, 18, and 24 months. Additional stress testing is done at 6 months after storing the product at 37° C for 2 weeks then testing at 1 and 2 weeks. Open/punctured vial testing is performed at the mid-point of the shelf life study period. Vials are stored on board the instrument and contents are tested in duplicate on days 0, 4, 7, 9, 11 and 14. Acceptance criteria must be met.
Value assignment:
The calibrator master lot values for IgG 1-4 are assigned versus ERM-DA 470 (CR 470) using independently determined values for subclasses compared to
{3}
total IgG value of the reference material. The master calibrator lot values for hemopexin and retinol binding protein are assigned versus highly purified protein preparations. Commercial lot values are then assigned versus Master Calibrators with 3 reference curves, 4 runs, 3 vials, 4 replicates per vial tested on two nephelometric systems for a total of 144 values. The sum of IgG 1-4 must be $\pm 20\%$ of the total IgG.
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
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Not applicable
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 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.
