(70 days)
Not Found
No
The description details a standard immunonephelometry assay for measuring CRP, which relies on chemical reactions and light scattering, not AI/ML algorithms for analysis or interpretation. There is no mention of AI, ML, or related concepts in the provided text.
No.
The device is an in vitro diagnostic test used to measure C-reactive protein (CRP) levels, which helps in the detection and evaluation of infection, tissue injury, and inflammatory disorders. It provides diagnostic information rather than directly treating a condition.
Yes
The device is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP), which is useful for the detection and evaluation of infection, tissue injury, and inflammatory disorders, thus serving a diagnostic purpose.
No
The device description clearly indicates that the device is a reagent cartridge and associated calibrators and controls, which are physical, liquid-based products used in an in vitro diagnostic test. It describes a process involving particle aggregation and light scattering, which are physical phenomena, not purely software operations.
Yes, all three devices described are explicitly stated to be IVDs (In Vitro Diagnostics) in their "Intended Use / Indications for Use" sections:
- Dimension Vista™ CRP Flex® reagent cartridge: "The CRP method is an in vitro diagnostic test..."
- Dimension Vista™ Protein 2 Calibrator: "Protein 2 Calibrator is an in vitro diagnostic product..."
- Dimension Vista™ Protein 2 Control L and H: "Protein 2 Control L and H are for use as assayed intralaboratory quality controls..." (While not explicitly using the phrase "in vitro diagnostic product" here, quality controls for an IVD test are considered part of the IVD system and are themselves IVDs).
N/A
Intended Use / Indications for Use
- Dimension Vista™ CRP Flex® reagent cartridge: The CRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and heparinized plasma by means of particle enhanced immunonephelometry on the Dimension Vista™ System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, and inflammatory disorders.
- Dimension Vista™ Protein 2 Calibrator: Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the Dimension Vista ™ System.
- Dimension Vista™ Protein 2 Control L and H: Protein 2 Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C-reactive protein (CRP) on the Dimension Vista™ System.
Product codes (comma separated list FDA assigned to the subject device)
DCK, JIX, JJY, DCN
Device Description
- Dimension Vista™ CRP Flex® reagent cartridge: Polystyrene particles coated with monoclonal antibodies specific to human CRP are aggregated when mixed with samples containing CRP. 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.
- Dimension Vista™ Protein 2 Calibrator: Protein 2 Calibrator is a liquid human serum based product containing C-reactive protein (CRP).
- Dimension Vista™ Protein 2 Control L and H: Protein 2 Control L and H are liquid human serum based products containing C-reactive protein (CRP).
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)
Method Comparison Study: The Dimension Vista™ CRP assay was compared to the Dade Behring CardioPhase® hsCRP assay on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 3.36 to 182.76 mg/L. Regression analysis of these results yielded the following equation: Dimension Vista™ CRP (y) = 0.985 (x) - 0.353, where x is the Dade Behring CardioPhase® hsCRP. The coefficient of correlation was 0.997. The sample size was 140.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
0
SEP - 6 2006
510(k) Summary for Dimension Vista™ CRP Flex® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L 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: KO60825
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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
Preparation date: August 24, 2006
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- Dimension Vista™ C-reactive protein Flex® reagent cartridge (CRP) Device Name: Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L Dimension Vista™ Protein 2 Control H
Classification: Class II; Class II: Class I Product Code: DCK; JIX, JJY Panel: Immunology (82) and Clinical Chemistry (75)
- Dimension Vista™ C-reactive protein Flex® reagent cartridge (CRP) Device Name: Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L Dimension Vista™ Protein 2 Control H
Fax: 781-826-2497
ldentification of the Legally Marketed Device: 3.
Dade Behring CardioPhase® hsCRP - K033908 Dade Behring N Rheumatology Standard SL - K964527 Dade Behring N/T Rheumatology Control SL - K962373
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4. Device Description:
Dimension Vista™ CRP Flex® reagent cartridge
Polystyrene particles coated with monoclonal antibodies specific to human CRP are aggregated when mixed with samples containing CRP. 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.
Dimension Vista™ Protein 2 Calibrator
Protein 2 Calibrator is a liquid human serum based product containing C-reactive protein (CRP).
Dimension Vista™ Protein 2 Control L and H
Protein 2 Control L and H are liquid human serum based products containing C-reactive protein (CRP).
5. Device Intended Use:
Dimension Vista™ CRP Flex® reagent cartridge:
The CRP method is an in vitro diagnostic test for the quantitative measurement of Creactive protein (CRP) in human serum and heparinized plasma by means of particle enhanced immunonephelometry on the Dimension Vista™ System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, and inflammatory disorders.
Dimension Vista™ Protein 2 Calibrator:
Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the Dimension Vista ™ System.
Dimension Vista™ Protein 2 Control L and H:
Protein 2 Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C-reactive protein (CRP) on the Dimension Vista™ System.
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista™ CRP Flex reagent cartridge, Dimension Vista™ Protein 2 Calibrator and Dimension Vista™ Protein 2 Control L and H are substantially equivalent to the Dade Behring CardioPhase® hsCRP assay (K033908) assay, N Rheumatology Standard SL (K964527) and N/T Rheumatology Control SL (K962373), respectively. The Dirension
Vista™ CRP assay, like the Dade Behring CardiPhase® hsCRP assay is an in vitro diagnostic reagent for the quantitative measurement of C-reactive protein (CRP) in human serum and plasma by means of particle enhanced immunonephelometry.
7. Device Performance Characteristics:
The Dimension Vista™ CRP assay was compared to the Dade Behring CardioPhase®
hsCRP assay on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 3.36 to 182.76 mg/L. Regression analysis of these results yielded the following equation:
Method Comparison Study
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| Dimension Vista™ CRP | 140 | 0.985 | -0.353 | Coefficient
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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 stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714
SEP - 6 2006
Re: K061825
Trade/Device Name: Dimension Vista™ CRP Flex® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Control L Dimension Vista™ Control H
Regulation Number: 21 CFR 866.5270
Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN, JIX, JJY Dated: June 27, 2006 Received: June 28, 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Guts
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
Dimension Vista™ CRP Flex® reagent cartridge Device Name: Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L Dimension Vista™ Protein 2 Control H
Indications for Use:
Dimension Vista™ CRP Flex® reagent cartridge:
The CRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and heparinized plasma by means of particle enhanced immunonephelometry on the Dimension Vista™ System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, and inflammatory disorders.
Dimension Vista™ Protein 2 Calibrator:
Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the Dimension Vista 10 System.
Dimension Vista™ Protein 2 Control L and Dimension Vista™ Protein 2 Control H:
Protein 2 Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C-reactive protein (CRP) 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)
Carol Benson
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Avision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K06/825