(88 days)
Not Found
No
The description focuses on a standard immunoassay method (particle aggregation and light scattering) and quality control materials. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is an in vitro diagnostic test used for the quantitative determination of β2-microglobulin, which aids in the diagnosis of renal dysfunction. It does not provide any therapeutic effect or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the B2MIC method is an "in vitro diagnostic " test and that "Measurements of ß2-microglobulin aid in the diagnosis of renal dysfunction."
No
The device description clearly outlines physical components like reagent cartridges, calibrators, and controls, which are used on a "Dimension Vista® System." This indicates a hardware-based in vitro diagnostic system, not a software-only device.
Yes, all three devices described are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use / Indications for Use: Each description explicitly states that the product is an "in vitro diagnostic test" or "in vitro diagnostic product." This is the most direct indicator.
- Nature of the Test: The descriptions detail tests performed on human samples (serum, plasma) to measure specific substances (β2-microglobulin, various proteins). This is the core function of an IVD.
- Purpose of the Test: The intended use for the B2MIC reagent cartridge is to "aid in the diagnosis of renal dysfunction," which is a diagnostic purpose. The calibrator and controls are used to ensure the accuracy and reliability of these diagnostic tests.
Therefore, based on the provided information, all three devices clearly fall under the definition of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Dimension Vista B2MIC Flex® reagent cartridge: The B2MIC method is an in vitro diagnostic test for the quantitative determination of β2-microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista® System. Measurements of ß2-microglobulin aid in the diagnosis of renal dysfunction.
Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the ß2-microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), lmmunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control M and H: PROT1 CON M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of ß2-microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin / transthyretin (PREALB) on the Dimension Vista® System.
Product codes (comma separated list FDA assigned to the subject device)
JZG; JIX; JJY
Device Description
Dimension Vista™ B2MIC Flex® reagent cartridge: Polystyrene particles coated with specific antibodies to human β2-microglobulin are aggregated when mixed with samples containing human ß2-microglobulin. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing β2microalobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB).
Dimension Vista" Protein 1 Control M and H: Protein 1 Control M and H are multi-analyte, liquid, human serum based products containing ß2-microglobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison Study: The Dimension Vista" B2MlC assay was compared to the Dade Behring N Latex β₂-Microglobulin assay on the BN ProSpec" System by evaluating serum and plaaksin Microgiobalin assay on the Bronney from 0.81 to 21.94 mg/L. Regression analysis of these results yielded the following equation: Slope: 0.942, Intercept: -0.029, Correlation Coefficient: 0.998, n: 143.
Conclusion: These studies demonstrate correlation and equivalent performançe between the Dade Behring N Latex β--Microglobulin assay and the Dimension Vista " B2MIC assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
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 § 866.9.
0
510(k) Summary for Dimension Vista" B2MIC Flex® reagent cartridge
Dimension Vista™ Protein 1 Control M and H
JAN 2 6 7007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K063272
-
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Dade Behring Marburg GmbH |
|---|---|
| Emil-von-Behring Str. 76 | |
| 35001 Marburg, Germany |
Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
- Preparation date: October 27, 2006
- Dimension Vista" B2MJC Flex® reagent cartridge
Dimension Vista" Protein 1 Calibrator
Dimension Vista" Protein 1 Control M
Dimension Vista" Protein 1 Control M 2. Device Name:
| Classification: | Class II; Class II; Class I |
|---|---|
| Product Code: | JZG; JIX; JJY |
| Panel: | Immunology (82) and Clinical Chemistry (75) |
3. Identification of the Legally Marketed Device:
Dade Behring N Latex β2-Microglobulin - K002731 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468
1
Dade Behring Inçi Dimension Vista B2MIC 510(k) Notification
4. Device Description:
Dimension Vista™ B2MIC Flex® reagent cartridge
Polystyrene particles coated with specific antibodies to human β2-microglobulin are aggregated when mixed with samples containing human ß2-microglobulin. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing β2microalobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB).
Dimension Vista" Protein 1 Control M and H
Protein 1 Control M and H are multi-analyte, liquid, human serum based products containing ß2-microglobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB).
5. Device Intended Use:
Dimension Vista " B2MIC Flex® reagent cartridge:
Dintenofon Tiota - Danno Piox - loagnostic test for the quantitative determination of ß2microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista System. Measuresments of ß2-microglobulin aid in the diagnosis of renal dysfunction.
Dimension Vista™ Protein 1 Calibrator:
PROT1 CAL is an in vitro diagnostic product for the calibration of the ß2-microglobulin (B2MIC), C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control M and H:
PROT1 CON M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of β2-microglobulin (Β2ΜΙΟ), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin / transthyretin (PREALB) on the Dimension Vista® System.
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista" B2MC Flex® reagent cartridge, Dimension Vista " Protein 1 Calibrator
and Dimension Vista" Protein 1 Control M and H are substantially equivalent to the D Behring N Latex (32-Microglobulin assay (K002731), N Protein Standard SL (K012470), and N/T Protein Control SL (K012468), respectively.
2
Device Performance Characteristics: 7.
The Dimension Vista" B2MlC assay was compared to the Dade Behring N Latex β>
Microglobulin assay on the BN ProSpec" System by evaluating serum and plaaksin Microgiobalin assay on the Bronney from 0.81 to 21.94 mg/L. Regression analysis of these results yielded the following equation:
Method Comparison Study
| Comparative Method | n | Slope | Intercept | Correlation Coefficient |
|---|---|---|---|---|
| N Latex β₂-Microglobulin | ||||
| on BN ProSpec® System | 143 | 0.942 | -0.029 | 0.998 |
8. Conclusion:
These studies demonstrate correlation and equivalent performançe between the Dade
Behring N Latex β--Microglobulin assay and the Dimension Vista " B2MIC assay.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring Inc. c/o Ms. Kathleen Dray-Lyons Regulatory Affairs and Compliance Manager Glasgow Site P.O. Box 6101 Newark, DE 19714-6101
JAN 26 2007
Re: K063272
Trade/Device Name: Dimension Vista™ B2MIC Flex® reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H Regulation Number: 21 CFR 866.5630 Regulation Name: Beta-2-Microglobulin Immunological Test System Regulatory Class: Class II Product Code: JZG, JIX, JJY Dated: December 20, 2006 Received: December 26, 2006
Dear Ms. Dray-Lyons:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 –
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Ret. J. Keating, Jr.
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications Statement
Device Name:
Dimension Vista" B2MIC Flex® reagent cartridge
Dimension Vista" Protein 1 Calibrator Dimension Vista" Protein 1 Control M
Dimension Vista" Protein 1 Control M
Dimension Vista" Protein 1 Control H
Indications for Use:
Dimension Vista™ B2MIC Flex® reagent cartridge:
The B2MIC method is an in vitro diagnostic test for the quantitative determination of β2-microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista® System. Measurements of ß2-microglobulin aid in the diagnosis of renal dysfunction.
Dimension Vista™ Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the ßmicroglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), lmmunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control M and H
PROT1 CON M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of ß2microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin / transthyretin (PREALB) on the Dimension Vista® System.
Prescription Use X (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
mana m cham
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Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
063272
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