(99 days)
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No
The description details a standard spectrophotometric assay for CRP, with no mention of AI or ML components.
No
This device is for in vitro diagnostic use, meaning it's used to analyze samples from the body to diagnose conditions, not to treat them. Its purpose is to quantify C-reactive protein in serum, which is a diagnostic measurement.
Yes
The "Intended Use / Indications for Use" states "For IN VITRO diagnostic use." and the "Device Description" explains it measures C-reactive protein (CRP) in serum, which is an indicator of inflammation and necrosis. These are hallmarks of a diagnostic device.
No
The device description clearly states it is a "CRP test system" that uses "antihuman CRP mouse antibody coated latex" and measures "agglutination from binding spectrophotometrically." This indicates a physical, in vitro diagnostic device that requires reagents and a spectrophotometer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For IN VITRO diagnostic use."
- Nature of the Test: The device is designed to measure a substance (C-reactive protein) in a biological sample (serum) outside of the body ("in vitro") to aid in diagnosis or monitoring of a condition (inflammation and necrosis). This is the core definition of an IVD.
N/A
Intended Use / Indications for Use
For the quantitative determination of C-reactive protein (CRP) in serum. For IN VITRO diagnostic use.
Product codes
DCK
Device Description
A CRP test system is a device intended to measure CRP in serum. C-Reactive Protein (CRP) is an abnormal protein synthesized in the liver during inflammation and necrosis of cellular tissue. This method, using antihuman CRP mouse antibody coated latex to bind CRP, allows for accurate measurement over a wide range of CRP concentrations. The resulting agglutination from binding is measured spectrophotometrically and is proportional to the concentration of CRP in the sample.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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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.
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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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§ 866.5270 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).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 stripes on its wing. 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
Ms. Penny White Regulatory Affairs Coordinator External, Diagnostic Division Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE C1E 2A6 Canada
APR 2 8 2006
Re: K060139
Trade/Device Name: CRP-ADVANCE Regulation Number: 21 CFR§866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: March 14, 2006 Received: March 17, 2006
Dear Ms. White:
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 aft 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 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
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Indications for Use
510(k) Number (if known): K060139
Device Name: CRP-ADVANCE
Indications For Use:
For the quantitative determination of C-reactive protein (CRP) in serum. For IN VITRO diagnostic use.
Identification.
A CRP test system is a device intended to measure CRP in serum. C-Reactive Protein (CRP) is an abnormal protein synthesized in the liver during inflammation and necrosis of cellular tissue. This method, using antihuman CRP mouse antibody coated latex to bind CRP, allows for accurate measurement over a wide range of CRP concentrations. The resulting agglutination from binding is measured spectrophotometrically and is proportional to the concentration of CRP in the sample.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety