DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN
K063508 · Dade Behring, Inc. · JIX · Jan 23, 2007 · Clinical Chemistry
Device Facts
Record ID
K063508
Device Name
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN
Applicant
Dade Behring, Inc.
Product Code
JIX · Clinical Chemistry
Decision Date
Jan 23, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1150
Device Class
Class 2
Indications for Use
The Dimension Vista™ Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the α1-acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System. The Dimension Vista™ Protein 1 Control L, M, and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System. The Dimension Vista™ Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) methods on the Dimension Vista® System. The Dimension Vista™ Protein 2 Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in the determination of antistreptolysin O (ASL), C-reactive protein (CRP) and Rheumatoid Factor (RF) on the Dimension Vista® System. The Dimension Vista™ Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the α1-microglobulin (A1MIC) and microalbumin (MALB) methods on the Dimension Vista® System. The Dimension Vista™ Protein 3 Control is for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-microglobulin (A1MIC) and microalbumin (MALB) on the Dimension Vista® System.
Device Story
Dimension Vista™ Protein 1, 2, and 3 Calibrators and Controls are liquid or lyophilized human serum/urine-based products used to calibrate and monitor the performance of specific protein assays on the Dade Behring Dimension Vista® System. Calibrators establish the relationship between instrument signal and analyte concentration; controls serve as independent samples to verify assay precision and bias. These products are used in clinical laboratory settings by trained laboratory personnel. The healthcare provider uses the resulting quality control data to validate the accuracy of patient test results before reporting. The benefit is ensuring the reliability and consistency of diagnostic protein measurements, which supports accurate clinical decision-making.
Clinical Evidence
No clinical data. Bench testing only. Stability studies conducted over 24 months at +2 to +8°C, including stress testing at +37°C and open-vial stability. Value assignment performed using reference curves across multiple runs, vials, and replicates on nephelometric instruments.
Technological Characteristics
Multi-analyte products; Protein 1/2 are liquid human serum-based; Protein 3 is lyophilized polygeline-based with human source proteins. Designed for use on the Dimension Vista System. No specific materials or software algorithms described for the calibrators/controls themselves.
Indications for Use
Indicated for use as in vitro diagnostic calibrators and assayed intralaboratory quality controls for the Dimension Vista® System to assess precision and analytical bias for specific protein analytes (A1AG, C3, C4, HAPT, IGA, IGG, IGM, PREALB, ASL, CRP, hsCRP, RF, A1MIC, MALB).
Regulatory Classification
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
Dimension Vista™ Protein 1 Calibrator (k062055)
Dimension Vista™ Protein 1 Control L, M, H (k062055)
Dimension Vista™ Protein 2 Calibrator (k062035)
Dimension Vista™ Protein 2 Control L, H (k062035)
Dimension Vista™ Protein 3 Calibrator (k061990)
Dimension Vista™ Protein 3 Control (k061990)
Submission Summary (Full Text)
{0}
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
k063508
B. Purpose for Submission:
510(k) premarket notification to manufacture and market the Dimension Vista™ Protein 1 Calibrator and the Dimension Vista™ Protein 1 Control (Low, Medium, and High). The calibrator and controls have been modified to include α1-acid glycoprotein (A1AG) and haptoglobin (HAPT).
510(k) premarket notification to manufacture and market the Dimension Vista™ Protein 2 Calibrator and the Dimension Vista™ Protein 2 Control (Low and High). The calibrator and controls have been modified to include antistreptolysin O (ASL).
510(k) premarket notification to manufacture and market the Dimension Vista™ Protein 3 Calibrator and the Dimension Vista™ Protein 3 Control. The calibrator and controls have been modified to include α₁-microglobulin (A1MIC).
C. Measurand:
None - submission is for clearance of calibrator and control material
D. Type of Test:
Calibrators and Controls
E. Applicant:
Dade Behring, Inc.
F. Proprietary and Established Names:
Dimension Vista™ Protein 1 Calibrator
Dimension Vista™ Protein 1 Control L
Dimension Vista™ Protein 1 Control M
Dimension Vista™ Protein 1 Control H
Dimension Vista™ Protein 2 Calibrator
Dimension Vista™ Protein 2 Control L
Dimension Vista™ Protein 2 Control H
Dimension Vista™ Protein 3 Calibrator
Dimension Vista™ Protein 3 Control
G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150 – Calibrator
21 CFR § 862.1660 – Quality control material (assayed and unassayed)
2. Classification:
Class II (calibrator)
{1}
Class I, reserved (controls)
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):
See indications for use below.
2. Indication(s) for use:
The Dimension Vista™ Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the α1-acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.
The Dimension Vista™ Protein 1 Control L, M, and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.
The Dimension Vista™ Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) methods on the Dimension Vista® System.
The Dimension Vista™ Protein 2 Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in the determination of antistreptolysin O (ASL), C-reactive protein (CRP) and Rheumatoid Factor (RF) on the Dimension Vista® System.
The Dimension Vista™ Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the α1-microglobulin (A1MIC) and microalbumin (MALB) methods on the Dimension Vista® System.
The Dimension Vista™ Protein 3 Control is for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-microglobulin (A1MIC) and microalbumin (MALB) on the Dimension Vista® System.
3. Special conditions for use statement(s):
For prescription use.
4. Special instrument requirements:
{2}
For use with the Dade Behring Dimension Vista® System
## I. Device Description:
**Dimension Vista™ Protein 1 Calibrator**: Protein 1 Calibrator is a liquid, human serum based product containing α1-acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB).
**Dimension Vista™ Protein 1 Controls L, M, and H**: Protein 1 Control L, M, and H are liquid, multi-analyte, human serum based products containing α1-acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) in three concentration ranges: low, medium, and high.
**Dimension Vista™ Protein 2 Calibrator**: Protein 2 Calibrator is a liquid, human serum based product containing antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF).
**Dimension Vista™ Protein 2 Controls L and H**: Protein 2 Control L and H are liquid, multi-analyte, human serum based products containing antistreptolysin O (ASL), C-reactive protein (CRP), high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) in two concentrations: low and high.
**Dimension Vista™ Protein 3 Calibrator**: Protein 3 Calibrator is a lyophilized, polygeline, based product of human urinary and serum proteins containing α1-microglobulin (A1MIC) and microalbumin (MALB).
**Dimension Vista™ Protein 3 Control**: Protein 3 Control is a lyophilized, polygeline, and rabbit albumin based product containing urinary α1-microglobulin (A1MIC) and serum albumin of human origin.
Refer to the product labeling for assigned values for each constituent. All human materials were tested by FDA approved methods and found to be negative for the presence of antibodies to HIV-1, HIV-2, HBsAg, and HCV.
## J. Substantial Equivalence Information:
1. Predicate device name(s):
Dimension Vista™ Protein 1 Calibrator
Dimension Vista™ Protein 1 Control L
Dimension Vista™ Protein 1 Control M
Dimension Vista™ Protein 1 Control H
Dimension Vista™ Protein 2 Calibrator
Dimension Vista™ Protein 2 Control L
Dimension Vista™ Protein 2 Control H
Dimension Vista™ Protein 3 Calibrator
Dimension Vista™ Protein 3 Control
{3}
2. Predicate 510(k) number(s):
k062055 - Dimension Vista™ Protein 1 Calibrator
k062055 - Dimension Vista™ Protein 1 Control L, M, H
k062035 - Dimension Vista™ Protein 2 Calibrator
k062035 - Dimension Vista™ Protein 2 Control L, H
k061990 - Dimension Vista™ Protein 3 Calibrator
k061990 - Dimension Vista™ Protein 3 Control
3. Comparison with predicates:
1. Dimension Vista™ Protein 1 Calibrator and Control (L, M, and H)
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Form | Liquid, human serum | Liquid, human serum |
| Traceability to | ERM®-DA470 (CRM470) | ERM®-DA470 (CRM470) |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | C3 complement, C4 complement, IgA, IgG, IgM and prealbumin | C3 complement, C4 complement, IgA, IgG, IgM, prealbumin, α1-acid glycoprotein, and haptoglobin |
2. Dimension Vista™ Protein 2 Calibrator and Control (L and H)
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Form | Liquid, human serum | Liquid, human serum |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Traceability to | ERM®-DA470 (C470) and 1stBritish Standard 64/0023 | 1stInternational Standard, ERM®-DA470 (C470) and 1stBritish Standard 64/0023 |
| Constituents | C-reactive protein (CRP), high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) | antistreptolysin O (ASL), C-reactive protein (CRP), high sensitivity CRP (hsCRP), and Rheumatoid Factors (RF) |
{4}
3. Dimension Vista™ Protein 3 Calibrator and Control
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Traceability to | ERM®-DA470 (C470) | ERM®-DA470 (C470) |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Form | Lyophilized, polygeline, human based albumin | Lyophilized, polygeline, and rabbit albumin based product containing urinary and serum proteins of human origin |
| Constituents | C-reactive protein (CRP), high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) | antistreptolysin O (ASL), C-reactive protein (CRP), high sensitivity CRP (hsCRP), and Rheumatoid Factors (RF) |
K. Standard/Guidance Document Referenced (if applicable):
Not Applicable
L. Test Principle:
Not Applicable
M. Performance Characteristics (if/when applicable): 3
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
Protein 1 Calibrator, Protein 1 Control (L, M, and H), Protein 3 Calibrator, and Protein 3 Control are traceable to ERM®-DA470 (CRM470). Protein 2 Calibrator and Protein 2 Control (L and H) are traceable to 1st International Standard, ERM®-DA470 (C470) and 1st British Standard 64/0023.
Value Assignment
The calibrator master lot value is assigned vs. ERM®-DA470 (CRM470) and 1st International Standard. The commercial calibrator lot value is assigned with three reference curves, 4 runs, 3 vials, 4 replicates per vial tested on two nephelometric instruments for a total of 144 values. The control values are assigned using the procedure outlined for the calibrators. Values assigned to
{5}
controls are calibrated by reference to protein standard preparations and are lot-dependent.
## Stability
The calibrators and the controls are tested per the same stability protocol. Products are stored at +2 to +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 at +37°C for two weeks. Once the products reach 50% shelf life stability, opened/punctured vial testing is performed on days 0, 4, 7, 9, 11, and 14.
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.
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
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.
