(94 days)
No
The description focuses on standard immunochemical reaction principles and comparison to known standards, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic test used to measure Immunoglobulin E, aiding in the diagnosis of allergic disorders, not directly treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the IGE method "is an in vitro diagnostic test" and that "Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings." This directly indicates its use for diagnosis.
No
The device description clearly indicates it is a reagent cartridge, calibrator, and control, which are physical components used in an in vitro diagnostic test. It describes the chemical reactions and light scattering principles involved, which are hardware-dependent processes.
Yes, all three devices described are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use / Indications for Use: All three descriptions explicitly state that the products are "in vitro diagnostic" tests or products.
- Nature of the Test: The descriptions detail tests performed on human biological samples (serum, heparinized plasma, EDTA plasma) outside of the body to provide information for the diagnosis or assessment of medical conditions (diagnosis of IgE mediated allergic disorders, calibration and quality control for various protein measurements).
- Device Description: The descriptions explain how the tests work (immunochemical reaction, light scattering) and the components involved (reagent cartridge, calibrator, controls), which are typical of IVD devices.
- Performance Studies: The inclusion of a Method Comparison Study further supports the classification as an IVD, as performance data is required for regulatory purposes for these types of devices.
- Predicate Devices: The listing of predicate devices (other IVD products) indicates that these devices are being compared to existing, legally marketed IVDs.
Therefore, based on the provided information, all three devices clearly fall under the definition of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Dimension Vista™ IGE Flex® reagent cartridge:
The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.
Dimension Vista™ Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control L, M and H
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.
Product codes
DGC, JIX, JJY
Device Description
Dimension Vista" IGE Flex® reagent cartridge
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes 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 C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Dimension Vista" Protein 1 Control L. M and H
Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (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
The Dimension Vista ™ IGE assay was compared to the Dade Behring N Latex IgE mono assay on the BN ProSpec® System by eveluating serum and plasma samples with concentrations ranging from 18.2 IU/mL to 1126.5 IU/mL. The study involved 120 samples. Regression analysis yielded the equation: y = 1.041x + 0.151 with a correlation coefficient of 0.999.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
Dade Behring Inc. Dimension Vista™ IGE 510(k) Notification
510(k) Summary for Dimension Vista" Dimension Vista™ Protein 1 Control L, M and H
FEB 1 5 2007
000104
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: K063425
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Dade Behring Marburg GmbH Emil-von-Behring Str. 76 35041 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: November 9, 2006 -
Dimension Vista" IGE Flex® reagent cartridge
Dimension Vista" Protein 1 Calibral or
Dimension Vista " Protein 1 Controllor
Dimension Vista " Protein 1 Control II M
Dimension 2. Device Name:
Classification: Class II; Class II; Class I Product Code: DGC; JIX; JJY Panel: Immunology (82) and Clinical Chemistry (75)
ldentification of the Legally Marketed Device: 3.
Dade Behring N Latex IgE mono- K991787 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468
1
Dade Behring Inc. Dimension Vista™ IGE 510(k) Notification
4. Device Description:
Dimension Vista" IGE Flex® reagent cartridge
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes 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 C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Dimension Vista" Protein 1 Control L. M and H
Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
5. Device Intended Use:
Dimension Vista™ IGE Flex® reagent cartridge:
The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of IGE aid in the diagnosis of the liated allergic disorders in conjunction with other clinical findings.
Dimension Vista™ Protein 1 Calibrator:
PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control L, M and H:
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vistas System.
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista™ IGE assay, like the Dade Behring N Latex IgE mono assay is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin E in human serum and plasma.
7. Device Performance Characteristics:
The Dimension Vista ™ IGE assay was compared to the Dade Behring N Latex IgE mono assay on the BN ProSpec® System by eveluating serum and plasma samples with concentrations ranging from 18.2 IU/mL to 1126.5 IU/mL. Regression analysis of these results yielded the following equation.
2
| 1 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1
| Method Comparison Study | ||||
|---|---|---|---|---|
| Intercept | ||||
| N Latex IgE mono on the | ||||
| BN ProSpec® | 120 | 1.041 | 0.151 | 0 999 |
Table 3
8. Conclusion:
These studies demonstrate correlation and equivalent performance between the Dade
Behring N Latex IgE mono assay and the Dimension Vista " IGE assay.
.
3
Image /page/3/Picture/1 description: The image shows a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle or bird-like figure with flowing lines, possibly representing movement or flight.
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
FEB 1 5 2007
Re: K063425
Trade/Device Name: Dimension Vista™ IgE Flex reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H
Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulin A, G, M, D and E Immunological Test System Regulatory Class: Class II Product Code: DGC, JIX, JJY Dated: January 10, 2007 Received: January 11, 2007
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
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 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" (21 CFR 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,
Robert H. Becker Jr.
Robert L. Becker, Jr., M.D., PH. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Dimension Vista™ IGF
Indications Statement
Device Name:
Dimension Vista™ IGE Flex® reagent cartridge Dimension Vista _ IGE Flex reagent ca
Dimension Vista _ Protein 1 Calibral L.
Dimension Vista _ Protein 1 Calibral L.
Dimension Vista _ Protein 1 Control M.
Dimension Vista Dimension Vista
Indications for Use:
Dimension Vista™ IGE Flex® reagent cartridge:
The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.
Dimension Vista™ Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control L. M and H
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (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)
maria In Che Division Sign-Off
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Division Sign-Off
W.L.N.I.A.L. R
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_________ Ko 63425
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