(78 days)
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No
The summary describes an in vitro diagnostic assay and calibrators, which are chemical reagents used for quantitative determination of CRP. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is an in-vitro diagnostic assay for measuring C-Reactive Protein, which aids in detection and evaluation of conditions, but it does not directly treat or prevent a disease or condition.
Yes
Explanation: The device is described as an "assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay" and states that "Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases." This indicates its use in aiding in the diagnosis of medical conditions.
No
The intended use describes an immunoturbidimetric assay for quantitative determination of CRP in serum and plasma, which is an in vitro diagnostic (IVD) test involving reagents and laboratory equipment, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the K-ASSAY® CRP (3) is intended for the "quantitative determination of CRP in serum and plasma by immunoturbidimetric assay." This describes a test performed on biological samples (serum and plasma) outside of the body to provide information about a person's health status (measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases). This is the definition of an in vitro diagnostic device.
The calibrators (K-ASSAY® CRP Multi-Calibrator D, E, and F) are also IVDs as they are intended to be used with the K-ASSAY® CRP (3) Assay, which is an IVD.
N/A
Intended Use / Indications for Use
The K-ASSAY® CRP (3) is intended to be used as a high sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay. Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases.
The K-ASSAY® CRP Multi-Calibrator D is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.
The K-ASSAY® CRP Multi-Calibrator E is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.
The K-ASSAY® CRP Multi-Calibrator F is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.
Product codes
DCK
Device Description
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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
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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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized human figure with three overlapping profiles, representing health and human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 0 4 2003
Kamiya Biomedical Company c/o Mr. Brian Schliesman Official Correspondent 910 Industry Drive Seattle, WA 98188
Re: K023828
Trade/Device Name: K-Assay® CRP (3) Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: January 14, 2003 Received: January 16, 2003
Dear Mr. Schliesman:
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
K-ASSAY® CRP (3) Device Name:
Indications For Use:
The K-ASSAY® CRP (3) is intended to be used as a high sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay. Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases.
The K-ASSAY® CRP Multi-Calibrator D is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.
The K-ASSAY® CRP Multi-Calibrator E is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.
The K-ASSAY® CRP Multi-Calibrator F is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Jean Cooper (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K023828 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
Optional Format 1-2-96)
CRP (3) 510(k) KAMIYA BIOMEDICAL COMPANY