(84 days)
No
The description focuses on standard immunochemical reaction principles and comparison with known calibrators, with no mention of AI or ML technologies.
No
The devices are described as "in vitro diagnostic tests" and "in vitro diagnostic products" used for quantitative measurements and calibration. They aid in diagnosis and quality control, but do not provide therapy or treatment.
Yes
The text explicitly states that the C3 and C4 methods are "in vitro diagnostic tests" and that "Measurements of C3 are used as an aid in the diagnosis of immunologic disorders." The Protein 1 Calibrator is also described as an "in vitro diagnostic product."
No
The device description clearly outlines physical components (reagent cartridges, calibrators, controls) which are chemical and biological substances used in an in vitro diagnostic test, not software.
Yes, based on the provided text, all the listed devices are described as In Vitro Diagnostic (IVD) devices.
Here's why:
- Explicit Statements: The "Intended Use / Indications for Use" section explicitly states that the C3 and C4 reagent cartridges, the Protein 1 Calibrator, and the Protein 1 Controls are "in vitro diagnostic" products or tests.
- Purpose: The descriptions clearly indicate that these devices are intended for use in a laboratory setting ("intralaboratory quality controls") to analyze human samples (serum and plasma) to aid in the diagnosis of medical conditions (immunologic disorders). This aligns with the definition of an IVD, which is a device intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Function: The devices perform functions typical of IVDs, such as quantitative measurement of analytes (C3, C4), calibration of tests, and quality control.
Therefore, the text strongly supports the conclusion that these devices are IVDs.
N/A
Intended Use / Indications for Use
Dimension Vista™ C3 Flex® reagent cartridge:
The C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.
Dimension Vista™ C4 Flex® reagent cartridge:
The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C4 are used as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.
Dimension Vista™ Protein 1 Calibrator:
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), and Immunoglobulin M (IGM) on the Dimension Vista™ System.
Dimension Vista™ Protein 1 Control L, Dimension Vista™ Protein 1 Control M and Dimension Vista™ Protein 1 Control H:
Protein 1 Control L/M/H are for use as an assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista™ System.
Product codes (comma separated list FDA assigned to the subject device)
CZW, DBI, JIX, JJY
Device Description
Dimension Vista™ C3 and C4 Flex® reagent cartridges
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 calibrator 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, Immunoglobulin G and lmmunoqlobulin M (IGM).
Dimension Vista™ Protein 1 Controls L/M/H
Protein 1 Controls L/M/H are multi-analyte, liquid human serum based products containing C3 Complement, C4 Complement, Immunoglobulin A, Immunoglobulin G and lmmunoglobulin M (IGM).
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
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).
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510(k) Summary for Dimension Vista™ C3 Flex® reagent cartridge Dimension Vista™ C4 Flex® reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L/M/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.
061852 The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
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- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
- Manufacturer: 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: June 29. 2006
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- Device Name: Dimension Vista™ C3 Complement Flex® reagent cartridge (C3) Dimension Vista™ C4 Complement Flex® reagent cartridge (C4) Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H
| Classification: | Class II; Class II; Class II; Class I |
|---|---|
| Product Code: | CZW; DBI; JIX; JJY |
| Panel: | Immunology (82) and Clinical Chemistry (75) |
3. Identification of the Legally Marketed Device:
050665 Dade Behring N Antisera to Human Complement Factors (C3c, C4) JJ99999 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468
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4. Device Description:
Dimension Vista™ C3 and C4 Flex® reagent cartridges
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 calibrator 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, Immunoglobulin G and lmmunoqlobulin M (IGM).
Dimension Vista™ Protein 1 Controls L/M/H
Protein 1 Controls L/M/H are multi-analyte, liquid human serum based products containing C3 Complement, C4 Complement, Immunoglobulin A, Immunoglobulin G and lmmunoglobulin M (IGM).
5. Device Intended Use:
Dimension Vista™ C3 Flex® Reagent Cartridge:
The C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.
Dimension Vista™ C4 Flex® Reagent Cartridge:
The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C4 are used as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.
Dimension Vista™ Protein 1 Calibrator:
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista " System.
Dimension Vista™ Protein 1 Control L/M/H:
Protein 1 Controls L/M/H are for use as an assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C3 Complement (C3), C4 Complement (C4), 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™ C3 and C4 Flex reagent cartridge. Dimension Vista™ Protein 1 Calibrator (K051087) and Dimension Vista™ Protein 1 Control L/M/H (K051087) are substantially equivalent to the Dade Behring N Antisera to Human Complement Factors (C3c, C4) assays (K050665), N Protein Standard SL (K012470) and N/T Protein Control SL (K012468), respectively. The Dimension Vista™ C3 and C4 assays, like the N Antisera to Human Complement Factors (C3c, C4) assays are in vitro diagnostic reagents
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 2 2006
Dade Behring, Inc. c/o Ms. Kathleen Dray-Lyons Regulatory Affairs and Compliance Manager Glasgow Site P.O. Box 6101 Newark, DE 19714
Re:´K061852´´´´ ´ ´ ´ ´ ´
Trade/Device Name: Dimension Vista™ C3 Flex® reagent cartridge Dimension Vista™ C4 Flex® reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L, Dimension Vista™ Protein 1 Control M and Dimension Vista™ Protein 1 Control H Regulation Number: 21 CFR 866.5240 Regulation Name: Complement Components Immunological Test System Regulatory Class: Class II Product Code: CZW, DBI, JIX, JJY Dated: June 29, 2006
Dear Ms. Dray-Lyons:
Received: June 30, 2006
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 CFR Part 807);
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labeling (21 CFR Part 801); 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.
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 yours,
Robert R. Becker
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
Device Name: Dimension Vista™ C3 Flex® reagent cartridge Dimension Vista™ C4 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™ C3 Flex® reagent cartridge:
The C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.
Dimension Vista™ C4 Flex® reagent cartridge:
The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C4 are used as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.
Dimension Vista™ Protein 1 Calibrator:
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), and Immunoglobulin M (IGM) on the Dimension Vista™ System.
Dimension Vista™ Protein 1 Control L, Dimension Vista™ Protein 1 Control M and Dimension Vista™ Protein 1 Control H:
Protein 1 Control L/M/H are for use as an assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista™ System.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Office of in Vitro Dlagnostic Device Evaluation and Safety
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