(56 days)
Not Found
No
The description focuses on standard immunochemical reaction principles and light scattering for quantitative measurement, with no mention of AI or ML technologies.
No
The device is described as an "in vitro diagnostic test" and "in vitro diagnostic product" used for quantitative measurement, calibration, and quality control of immunoglobulins in human serum and plasma, which aids in diagnosis. It does not directly treat or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the IgM method is an "in vitro diagnostic test" and that "Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This clearly indicates its role in diagnosis.
No
The device description clearly indicates the device is a reagent cartridge, calibrator, and control, which are physical components used in an in vitro diagnostic test. It describes an immunochemical reaction and light scattering, which are hardware-dependent processes. There is no mention of software as the primary or sole component.
Yes, all three devices described are explicitly stated to be In Vitro Diagnostic (IVD) devices in their "Intended Use / Indications for Use" sections.
Here's why:
- Dimension Vista™ IGM Flex® reagent cartridge: The intended use clearly states it is "an in vitro diagnostic test".
- Dimension Vista™ Protein 1 Calibrator: The intended use states it is "an in vitro diagnostic product".
- Dimension Vista™ Protein 1 Control L, M and H: While not explicitly using the phrase "in vitro diagnostic test", the description of their use as "assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) on the Dimension Vista™ System" aligns with the function of an IVD control. Furthermore, the predicate devices listed are also IVD products.
Therefore, based on the provided text, all three devices are IVDs.
N/A
Intended Use / Indications for Use
The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma 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.
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista™ System.
Protein 1 Control L, M and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) on the Dimension Vista™ System.
Product codes
CFN, JIX, JJY
Device Description
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.
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing Immunoglobulin A, Immunoglobulin G, and Immunoglobulin M.
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 Immunoglobulin A, Immunoglobulin G, and Immunoglobulin M.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary for Dimension Vista™ IGM Flex® reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L, M and H
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: _______________________________________________________________________________________________________________________________________________
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- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
Manufacturer:
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-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: August 8, 2006
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- Device Name:
Dimension Vista™ IGM 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
- Device Name:
| Classification: | Class II; Class II; Class I |
|---|---|
| Product Code: | CFN; JIX; JJY |
| Panel: | Immunology (82) and Clinical Chemistry (75) |
3. Identification of the Legally Marketed Device:
Dade Behring N Antisera to Human IgM - K042735 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468
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4. Device Description:
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.
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing Immunoglobulin A, Immunoglobulin G, and Immunoglobulin M.
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 Immunoglobulin A, Immunoglobulin G, and Immunoglobulin M.
5. Device Intended 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 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.
Dimension Vista™ Protein 1 Calibrator:
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods
on the Dimension Vista™ System.
Dimension Vista™ Protein 1 Control L, M and H:
Protein 1 Control L, M and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) on the Dimension Vista™ System.
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista™ IGM Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H are substantially equivalent to the the Dade Behring N Antisera to Human IgM assay (K042735), N Protein Standard SL (K012470) and N/T Protein Control SL (K012468), respectively. The Dimension Vista™ IGM assay, like Dade Behring N Antisera to Human IGM assay is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and plasma by means of particle enhanced immunonephelometry.
7. Device Performance Characteristics:
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the department's name and national scope. The logo is presented in black and white, giving it a formal and official appearance.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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
AUG 2 4 2006
Re: K061845
Trade/Device Name: Dimension Vista™ Immunoglobulin M Flex® Reagent Cartridee (IgM) Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension VistaTM Protein 1 Control H Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test System Regulatory Class: Class II Product Code: CFN, JIX, JJY Dated: June 28, 2006
Received: June 29, 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 cither 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality
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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.
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 Compliance at (240) 276-0484. 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 vours.
Tobe M. Bockerf
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
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Indications Statement
570(K) 061845
Device Name:
Dimension Vista™ IGM 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
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 on the Dimension Vista 10 System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista™ System.
Dimension Vista™ Protein 1 Control L, M and H
Protein 1 Control L. M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM)
on the Dimension Vista™ System.
Prescription Use × (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)
"marie M. Chen"
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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 061845