(27 days)
No
The document describes a control material for a CRP assay and does not mention any AI or ML components.
No
Explanation: The device is a control material for monitoring and evaluating the precision and accuracy of C-reactive protein (CRP) assays, not a device used for therapy.
No
This device is described as a "control material intended to monitor and evaluate the precision and accuracy of quantitative C-reactive protein (CRP) assays." It explicitly states that it is for use with a diagnostic test system (NycoCard® CRP point-of-care test system), but it is not itself a test that measures a patient's condition or aids in diagnosis. It's a quality control material.
No
The device is described as a control material (human serum) for a point-of-care test system, indicating it is a physical substance, not software.
Based on the provided information, the NycoCard® CRP Control is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that it is a "human serum control material intended to monitor and evaluate the precision and accuracy of quantitative C-reactive protein (CRP) assays." This function of evaluating the performance of a diagnostic test is a key characteristic of an IVD control material.
- Use with an IVD System: It is specifically recommended for use with the NycoCard® CRP point-of-care test system, which is itself an IVD device (indicated by the 510(k) submission and K number). Control materials are essential components of IVD systems to ensure the reliability of the test results.
- Measurement of a Biomarker: The CRP assay it is used with measures C-reactive protein, a biomarker used in the evaluation of injury to body tissue. This is a diagnostic application.
While the document doesn't explicitly state "This is an IVD device," its function and intended use within the context of a diagnostic testing system strongly indicate that it falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NycoCard® CRP Control is an assayed human serum control material intended to monitor and evaluate the precision and accuracy of quantitative C-reactive protein (CRP) assays. It is particularly recommended for use with the NycoCard® CRP point-of-care test system for determination of C-reactive protein (510(k) submission date November 13. 2001, (K013787, Establishment Registration Number 1931251). Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.
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
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human figures connected by flowing lines, representing the department's focus on health and human well-being.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 0 7 2002
Jimmie K. Noffsinger, Ph.D. Vice President - Research & Development Primus Corporation P.O. Box 22599 Kansas City, MO 64113
Re: K014084
Trade/Device Name: NycoCard® CRP Control Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: December 11, 2001 Received: December 11, 2001
Dear Dr. Noffsinger:
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); 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.
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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INTENDED USE STATEMENT:
| 510(k) Number: | K014084 |
|---|---|
| Device Name: | NycoCard CRP Control |
Indications For Use:
The NycoCard® CRP Control is an assayed human serum control material intended to monitor and evaluate the precision and accuracy of quantitative C-reactive protein (CRP) assays. It is particularly recommended for use with the NycoCard® CRP point-ofcare test system for determination of C-reactive protein (510(k) submission date November 13. 2001, (K013787, Establishment Registration Number 1931251). Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use v (Per 21 CFR 801.109) OR
Over-the-Counter Use (Optional Format 1-2-96)
FAX: 816-361-1974
Ollachitt
(Division Sign-Off) Division of Clinical Laborator KO1401 510(k) Number
PO Box 22599
Kansas City, MO 64113
816-523-7491
900.27
Page 5 800-377-4752