(76 days)
Not Found
No
The device description and performance studies focus on standard immunonephelometry techniques and comparisons to predicate devices using regression analysis. There is no mention of AI or ML in the intended use, device description, or performance evaluation.
No
The device is described as an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) and is used for evaluation and risk stratification, not treatment.
Yes
The device is an in vitro diagnostic test used for the quantitative measurement of C-reactive protein (CRP) in human serum and plasma, with the stated purpose of evaluating conditions associated with inflammation and as a risk marker for cardiovascular disease. This falls under the definition of a diagnostic device as it is intended to diagnose diseases or conditions.
No
The device description clearly details physical components like reagent cartridges, calibrators, and controls, which are used in conjunction with the Dimension Vista™ System (a hardware platform). The performance studies also describe a method comparison using physical samples and a laboratory system. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated in Intended Use: The "Intended Use / Indications for Use" section for all three components (reagent cartridge, calibrator, and controls) explicitly states that they are "in vitro diagnostic test" or "in vitro diagnostic product".
- Measurement of Analyte in Human Samples: The device measures C-reactive protein (CRP) in human serum and plasma. This is a key characteristic of an in vitro diagnostic device, as it analyzes biological samples taken from the human body.
- Used for Medical Purposes: The intended use describes how the hsCRP measurements are used for medical purposes, including evaluating inflammation, identifying cardiovascular disease risk, and assessing prognosis in patients with coronary disease.
- Used in a Clinical Laboratory Setting: The intended user is clinical laboratory personnel, and the care setting is a clinical laboratory. This is the typical environment for the use of IVD devices.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge:
The CardioPhase® hsCRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and plasma by means of particle enhanced immunonephelometry on the Dimension Vista™ System. High sensitivity CRP measurements may be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals and as an independent risk marker for the identification and stratification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Dimension Vista™ Protein 2 Calibrator:
Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the high sensitivity C-reactive protein (hsCRP) method on the Dimension Vista™ System.
Dimension Vista™ high sensitivity CRP Control L and Dimension Vista™ high sensitivity CRP Control H:
hsCRP 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)
NQD, JJY, JIX
Device Description
Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge:
Dimension Vista - Ourdror naoo nal antibodies specific to human CRP are Polystylene particles couled with samples containing CRP. These aggregates scater a beam aggregated when mixed with our prob seintersity of the scattered light is proportional to of light passed through the sample. 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™ high sensitivity CRP Control L and H:
Dimension Vista – Migh ochoand H are liquid human serum based products containing C-reactive protein.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum and 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™ CardioPhase® hsCRP 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 0.169 to 8.922 mg/L. Regression analyses of these results yielded the following equations: (table not human readable but text indicates regression analyses were performed and results are presented in a table).
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
510(k) Summary for Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ high sensitivity CRP 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: K061802
1. 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 26, 2006 -
- Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge Device Name: (hsCRP) Dimension Vista™ Protein 2 Calibrator Dimension Vista™ high sensitivity CRP Control L Dimension Vista™ high sensitivity CRP Control H
| Classification: | Class II; Class II; Class I |
|---|---|
| Product Code: | NQD; JJY |
| Panel: | Immunology (82) and Clinical Chemistry (75) |
3. Identification of the Legally Marketed Device:
Dade Behring CardioPhase® hsCRP - K033908 Dade Behring N Rheumatology Standard SL - K964527 Dade Behring N/T Rheumatology Control SL - K962373
1
Device Description: 4.
Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge
Dimension Vista - Ourdror naoo nal antibodies specific to human CRP are Polystylene particles couled with samples containing CRP. These aggregates scater a beam aggregated when mixed with our prob seintersity of the scattered light is proportional to of light passed through the sample. 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™ high sensitivity CRP Control L and H
Dimension Vista – Migh ochoand H are liquid human serum based products containing C-reactive protein.
Device Intended Use: 5.
Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge:
Dimension Vista - GardioPhase® hsCRP method is an in vitro diagnostic test for the The Dimension Vista - Ourdler nabels nabels (CRP) in human serum and plasma by qualificative measurement of O reading protoin (Oril) The Dimension Vista™ System. means of particle chinanopheloments may be used for evaluation of conditions thought to High sensitivity ONT "headlinents they be abeathy individuals and as an independent risk marker for the identification and stratification of individuals at risk for future nsk marker for the lookillioution aments of hsCRP, when used in conjunction with candiovasouler alsociolinem of acute coronary syndromes, may be useful as an traditional cilinical laboratory overlaxion of courts, in patients with stable coronary disease or acute coronary syndromes.
Dimension Vista™ Protein 2 Calibrator:
Dimension is an in vitro diagnostic product for the calibration of the high Protein 2 Calibrator is an in vitro diagnostic production of the Samfration Vista ™ System.
Dimension Vista™ high sensitivity CRP Control L and H:
Dimension Vista - Thigh received intralaboratory quality controls for the hisCNF Gollitor Land IT are for door as learnination of C-reactive protein (CRP) on the Dimension Vista™ System.
Medical device to which equivalence is claimed and comparison information: 6.
The CardioPhase® hsCRP Flex® reagent cartridge, Dimension Vista™ Protein 2 Calibrator The Cardior hase 1/30 N F FCX Tougone carone L and H are substantially equivalent to and Dilflension Vista - Thigh Schollinky C.Kr - ov.r - & / K033908) assay, N Rheumatology Standard the Dide Belining Cardior nasc "hoon" dood (K96233), respectively, The Dimension
SL (K964527) and NT Rheumatology Control SL (K96233), respectively, The Dimension of Street Visia ™ Cardior nase " 18011" assurement of C-reactive protein (CRP) in human in vitro diagnostic tool for the qr particle enhanced immunonephelometry.
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7. Device Performance Characteristics:
The Dimension Vista™ CardioPhase® hsCRP 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 0.169 to 8.922 mg/L. Regression analyses of these results yielded the following equations:
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Complete Choice Comments
A
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Telation
Comments of the Council Concession
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Method Comparison Study
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 2006
Ms. Kathleen Dray-Lyons Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, DE 19714
Re: K061802
Trade/Device Name: Dimension Vista™ CardioPhase® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ high sensitivity CRP Control L Dimension Vista™ high sensitivity CRP Control H Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NQD, JIX, JJY Dated: June 26, 2006 Received: June 27, 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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Page 2 -
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 Gutz
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
5
mension Vista™ CardioPhase® hsCRP
Indications Statement
Device Name:
Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ high sensitivity CRP Control L Dimension Vista™ high sensitivity CRP Control H
Indications for Use:
Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge:
The CardioPhase® hsCRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and plasma by means of particle enhanced immunonephelometry on the Dimension Vista™ System. High sensitivity CRP measurements may be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals and as an independent risk marker for the identification and stratification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Dimension Vista™ Protein 2 Calibrator:
Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the high sensitivity C-reactive protein (hsCRP) method on the Dimension Vista™ System.
Dimension Vista™ high sensitivity CRP Control L and Dimension Vista™ high sensitivity CRP Control H:
hsCRP 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 C Bonam
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
K 061802