(55 days)
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No
The description details a standard nephelometry method for quantitative measurement of proteins, which relies on light scattering and comparison to a calibrator. There is no mention of AI, ML, or any learning algorithms.
No
This device is an in vitro diagnostic test used for the quantitative measurement of Immunoglobulin A and M, aiding in diagnosis, not for providing therapy.
Yes
Explanation: The Intended Use/Indications for Use section explicitly states that the device is an "in vitro diagnostic test" for measuring Immunoglobulin A and M, and that these measurements "aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This directly indicates its role in diagnosis.
No
The device description explicitly states it is a "reagent cartridge" and describes a physical immunochemical reaction involving "Proteins contained in human body fluids" and "specific antibodies," which are hardware components. It also mentions nephelometry on the "Dimension Vista System," which is a physical instrument.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The IgA method is an in vitro diagnostic test..."
- "The IgM method is an in vitro diagnostic test..."
This clearly indicates that the device is intended for use in vitro (outside the living body) to diagnose conditions.
N/A
Intended Use / Indications for Use
Dimension Vista® IgA Flex® Reagent Cartridge:
The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma by means of nephelometry on the Dimension Vista® System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Dimension Vista® IGM Flex® reagent cartridge:
The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma by means of nephelometry on the Dimension Vista" System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Product codes (comma separated list FDA assigned to the subject device)
CFN
Device Description
Dimension Vista® IGA 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 calibrator of known concentration.
Dimension Vista® IGM 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
In support of the extended range, the Dimension Vista® IgA assay was compared to N Antiserum to Human IqA on the BN ProSpec® System by evaluating 28 serum samples at the extended low end of the assay range with concentrations ranging from 0.062 to 0.246 g/L.
In support extended range, the Dimension Vista® IgM assay was compared to N Antiserum to Human IgM on the BN ProSpec® System by evaluating 26 serum samples at the extended low end of the measuring range with concentrations ranging from 0.052 to 0.200 g/L.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison Study for Dimension Vista® IgA:
Sample Size: 28 serum samples
Concentration Range: 0.062 to 0.246 g/L
Regression analysis yielded the following equations:
Slope (95%CI): 1.000 (1.000, 1.000)
Intercept (95%CI): 0.000 (0.000, 0.000)
Correlation Coefficient r: 0.992
Correlation Coefficient r2: 0.983
Method Comparison Study for Dimension Vista® IgM:
Sample Size: 26 serum samples
Concentration Range: 0.052 to 0.200 g/L
Regression analysis yielded the following equations:
Slope (95%CI): 1.023 (0.967, 1.122)
Intercept (95%CI): 0.004 (-0.004, 0.008)
Correlation Coefficient r: 0.989
Correlation Coefficient r2: 0.979
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
510(k) Summary for Dimension Vista® IGA Assay Dimension Vista® IGM Assay
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.
090594
Manufacturer's Name. Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Siemens Healthcare Product GmbH |
|---|---|
| Emil von Behring Str. 76 | |
| Marburg, 35041 Germany |
- Contact Information: Siemens Healthcare Diagnostics P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date: April 9, 2009
The assigned 510(k) number is:
Dimension Vista® IGA Flex® reagent cartridge 2. Device Name: Dimension Vista® IGM Flex® reagent cartridge
| Classification: | Class II; Class II |
|---|---|
| Product Code: | CFN |
| Panel: | Immunology (82) |
3. Identification of the Legally Marketed Device:
Siemens N Antisera to Human IgA (K042735) Siemens N Antisera to Human IgM (K042735)
Device Description: 4.
Dimension Vista® IGA 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 calibrator of known concentration.
Dimension Vista® IGM 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.
1
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.
.
ﮩ ﭘ
:
2
ട. Device Intended Use:
Dimension Vista® IgA Flex® Reagent Cartridge:
The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma by means of nephelometry on the Dimension Vista System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Dimension Vista® IGM Flex® reagent cartridge:
The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma by means of nephelometry on the Dimension Vista" System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Medical device to which equivalence is claimed and comparison information: દ.
The Dimension Vista® IGA reagent cartridge and Dimension Vista "IGM reagent cartridge and are substantially equivalent to the Siemens N Antisera to Human IgA assay (K042735) and Siemens N Antisera to Human IgM (K042735) respectively. The Dimension Vistar IGA and IGM assays, like the N Antisera to Human IgA and IgM assays are an in vitro diagnostic reagents for the quantitative measurement of Immunoglobulin A and Immunoglobulin M in human serum and plasma.
7. Device Performance Characteristics:
In support of the extended range, the Dimension Vista® IgA assay was compared to N Antiserum to Human IqA on the BN ProSpec® System by evaluating 28 serum samples at the extended low end of the assay range with concentrations ranging from 0.062 to 0.246 g/L. Regression analysis of these results yielded the following equations:
| | n | Slope
(95%CI) | Intercept
(95%CI) | Correlation
Coefficient
r | Correlation
Coefficient
r2 |
|-------------------------|----|-------------------------|-------------------------|---------------------------------|----------------------------------|
| Dimension Vista®
IgA | 28 | 1.000
(1.000, 1.000) | 0.000
(0.000, 0.000) | 0.992 | 0.983 |
Method Comparison Study
In support extended range, the Dimension Vista® IgM assay was compared to N Antiserum to Human IgM on the BN ProSpec® System by evaluating 26 serum samples at the extended low end of the measuring range with concentrations ranging from 0.052 to 0.200 g/L. Regression analysis of these results yielded the following equations:
| | n | Slope
(95%CI) | Intercept
(95%CI) | Correlation
Coefficient
r | Correlation
Coefficient
r2 |
|-------------------------|----|-------------------------|--------------------------|---------------------------------|----------------------------------|
| Dimension Vista®
IgM | 26 | 1.023
(0.967, 1.122) | 0.004
(-0.004, 0.008) | 0.989 | 0.979 |
Method Comparison Study
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics c/o Ms Kathleen Ann Dray-Lyons Manager, Regulatory Affairs 500 GBC Drive P.O.Box 6101 Newark, DE 19714-6101
APR 2 9 2009
Re: K090594
Trade/Device Name: Dimension Vista® IGA Flex® reagent cartridge Dimension Vista® IGM 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: CFN Dated: March 03, 2009 Received: March 05, 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 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 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.
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 Parts 801 and 809); medical device reporting (reporting of
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Page 2 - Ms Kathleen Ann Dray-Lyons
medical device-related adverse events) (21 CFR 803); and 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 advice for your device on our labeling regulation (21 CFR Part 801), 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 vours.
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
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Indications for Use
510(k) Number (if known):
Dimension Vista® IGM Flex® reagent cartridge Device Name:
Indications For Use:
Dimension Vista® IGM Flex® reagent cartridge:
The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma by means of nephelometry on the Dimension Vista® System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter-Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Page 1 of
Manai M Chan
Division Sign-Off
Office of In Vitro Diagnostic ce Evaluation and Safety
510(k) K090594
6
Indications for Use
510(k) Number (if known):
Dimension Vista® IGA Flex® reagent cartridge Device Name:
Indications For Use:
Dimension Vista® IgA Flex® Reagent Cartridge:
The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma by means of nephelometry on the Dimension Vista® System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Prescription Use X . (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Maria M. Chan
Division Sign-Off
Office of In Vitro Dlagnostic Device Evaluation and Safety
s10(k) K090594