(84 days)
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Not Found
No
The device description details a standard immunochemical reaction and light scattering measurement, with results evaluated by comparison to a known standard. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic test used for quantitative measurement to aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the IGG methods are "in vitro diagnostic tests" and "aid in the diagnosis of plasma cell antibody forming abnormalities."
No
The device description explicitly details reagent cartridges and their interaction with samples, indicating a physical component and chemical reaction, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the methods are "in vitro diagnostic tests". This is the primary indicator that the device falls under the category of IVDs. The description of the device and its function also aligns with the nature of in vitro diagnostic tests, which analyze samples taken from the human body to aid in diagnosis.
N/A
Intended Use / Indications for Use
The IGG1 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 1 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. Measurements of immunoglobulin G subclass 1 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
The IGG2 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 2 in human serum. heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 2 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
The IGG3 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 3 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. Measurements of immunoglobulin G subclass 3 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
The IGG4 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 4 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 4 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findinas.
Product codes
DFZ
Device Description
Dimension Vista® IGG 1-2 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 respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista® IGG 3-4 Flex® reagent cartridge: Antibodies as well as polystyrene particles coated with antibodies specific to human IGG3 or IGG4 are aggregated when mixed with samples containing IGG3 or IGG4. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum, heparinized plasma and EDTA plasma
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® IGG 1 and 2 assays were compared to N Antiserum to Human IgG Subclasses 1 and 2 on the BN ProSpec® System.
Dimension Vista® IGG1: n=129, Slope=1.002, Intercept=-0.165 g/L, Correlation Coefficient=0.994
The Dimension Vista® IGG 3 and 4 assays were compared to N N Latex IgG3 and IgG4 on the BN ProSpec® System.
Dimension Vista® IGG3: n=142, Slope=1.047, Intercept=-0.002 g/L, Correlation Coefficient=0.993
Dimension Vista® IGG4: n=150, Slope=1.020, Intercept=-0.009 g/L, Correlation Coefficient=0.996
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Siemens N Antisera to Human IgG subclasses 1 and 2, Siemens N Latex IqG Subclasses 3 and 4
Reference Device(s)
Not Found
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
OCT 21 2009
510(k) Summary for Dimension Vista® IGG Subclass 1 Assav Dimension Vista® IGG Subclass 2 Assay Dimension Vista® IGG Subclass 3 Assay Dimension Vista® IGG Subclass 4 Assav
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: _______________________________________________________________________________________________________________________________________________
Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation: 1.
| Manufacturer: | Siemens Healthcare Product GmbH
Emil von Behring Str. 76
Marburg, 35041 Germany |
| --------------- | --------------------------------------------------------------------------------------- |
|---|
Siemens Healthcare Diagnostics Contact Information: P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date: September 9, 2009
- Dimension Vista® IGG1 Flex® reagent cartridge 2. Device Name: Dimension Vista® IGG2 Flex® reagent cartridge Dimension Vista® IGG3 Flex® reagent cartridge Dimension Vista® IGG4 Flex® reagent cartridge
IGG (Gamma Chain Specific),Class II Classification: Product Code: DFZ Immunology (82) Panel:
Identification of the Legally Marketed Device: 3.
Siemens N Antisera to Human IgG subclasses 1 and 2 Siemens N Latex IqG Subclasses 3 and 4
4. Device Description:
Dimension Vista® IGG 1-2 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 respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
1
Dimension Vista® IGG 3-4 Flex® reagent cartridge
Antibodies as well as polystyrene particles coated with antibodies specific to human IGG3 or IGG4 are aggregated when mixed with samples containing IGG3 or IGG4. 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.
5. Device Intended Use:
Dimension Vista® IGG1 Flex® Reagent Cartridge:
The IGG1 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 1 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. Measurements of immunoglobulin G subclass 1 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
Dimension Vista® IGG2 Flex® reagent cartridge:
The IGG2 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 2 in human serum. heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 2 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
Dimension Vista® IGG3 Flex® reagent cartridge:
The IGG3 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 3 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. Measurements of immunoglobulin G subclass 3 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
Dimension Vista® IGG4 Flex® reagent cartridge:
The IGG4 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 4 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 4 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findinas.
Medical device to which equivalence is claimed and comparison information: 6.
The Dimension Vista® (GG1, 2, 3 and 4 reagent cartridges are substantially equivalent to the Siemens N Antisera to Human IqG Subclasses 1 and 2 assay and Siemens N Latex IgG3 and 4 respectively. The Dimension Vista® IGG1, 2, 3 and 4 assays, like the N Antisera to Human IgG Subclasses 1 and 2 and N Latex IGG 3 and 4 assays are an in vitro diagnostic reagents for the quantitative measurement of immunoglobulin G subclass 1-4 in human serum and plasma.
7. Device Performance Characteristics:
The Dimension Vista® IGG 1 and 2 assays were compared to N Antiserum to Human IgG Subclasses 1 and 2 on the BN ProSpec® System. Regression analysis of these results yielded the following equations:
| Method Comparison Study | ||||
|---|---|---|---|---|
| n | Slope | Intercept | ||
| g/L | Correlation | |||
| Coefficient | ||||
| Dimension Vista® IGG1 | 129 | 1.002 | -0.165 | 0.994 |
Method Comnarison Study
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The Dimension Vista® IGG 3 and 4 assays were compared to N N Latex IgG3 and IgG4 on the BN ProSpec® System. Regression analysis of these results yielded the following equations:
| n | Slope | Intercept
g/L | Correlation
Coefficient | |
|-----------------------|-------|------------------|----------------------------|-------|
| Dimension Vista® IGG3 | 142 | 1.047 | -0.002 | 0.993 |
| Dimension Vista® IGG4 | 150 | 1.020 | -0.009 | 0.996 |
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Method Comparison Study
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: 上一篇:
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT 2 1 2009
Siemens Healthcare Diagnostics c/o Ms. Kathleen Ann Dray-Lyons Manager, Regulatory Affairs 500 GBC Drive PO Box 6101 Newark, DE 19714
Re: K092283
Trade/Device Name: Dimension Vista® IgG Subclass 1 Flex® reagent cartridge Dimension Vista® IgG Subclass 2 Flex® reagent cartridge Dimension Vista® IgG Subclass 3 Flex® reagent cartridge Dimension Vista® IgG Subclass 4 Flex® reagent cartridge Regulation Number: 21 CFR §866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E Immunological Test System Regulatory Class: Class II Product Code: DFZ Dated: July 27, 2009 Received: July 29, 2009
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Kathleen Ann Dray-Lyons
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entifled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ia m chan
Maria M. Chan, 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
510(k)Number: K092283
Device Name: Dimension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridge
The IgG1 method is an in vitro diagnostic test for the quantitative Indications for Use: measurement of immunoglobulin G subclass 1 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass I aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
Prescription use X AND/OR
Over-the-counter use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)
Reena Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safeh
51910 K092283
Page 1 of 4
6
510(k)Number: K092283
Device Name: Dimension Vista® Immunoglobulin G Subclass 2 Flex® reagent cartridge
The IgG2 method is an in vitro diagnostic test for the quantitative Indications for Use :measurement of immunoglobulin G subclass 2 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 2 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
Prescription use X
AND/OR
Over-the-counter use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)
Reena Philip
ASSEL Barres
Office of In Vitro Diagnostic Device Evaluation and Safely
092283
Page 2 of 4
7
510(k)Number: K092283
Device Name: Dimension Vista® Immunoglobulin G Subclass 3 Flex® reagent cartridge
The IgG3 method is an in vitro diagnostic test for the quantitative Indications for Use: measurement of immunoglobulin G subclass 3 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 3 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
Prescription use X
AND/OR
Over-the-counter use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)
Page 3 of 4
Reena Philip
Office of in Vitro Diagnostic Device Evaluation and Sufam
092283
8
510(k)Number: K092283
Device Name: Dimension Vista® Immunoglobulin G Subclass 4 Flex® reagent cartridge
The IgG4 method is an in vitro diagnostic test for the quantitative Indications for Use: measurement of immunoglobulin G subclass 4 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 4 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.
Prescription use X AND/OR
Over-the-counter use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)
Page 4 of 4
Reena Philip
Office of In Vino Dictions Device Evaluation and 1 tim
092283