(350 days)
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No
The summary describes an in vitro diagnostic test using ELISA, which is a standard laboratory technique and does not mention any AI or ML components.
No
Explanation: This device is an in vitro diagnostic test designed to detect specific autoantibodies in human serum to aid in the diagnosis of Rheumatoid arthritis. It does not directly treat or prevent a disease, which is the primary function of a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The TheraTest EL-anti-CCP/2™ test is intended for use in clinical laboratories as an in vitro diagnostic test..." and "It is intended to aid in the diagnosis of Rheumatoid arthritis (RA)".
No
The device is an in vitro diagnostic test (ELISA) which is a laboratory test involving physical reagents and samples, not a software-only device.
Yes, based on the provided information, the TheraTest EL-anti-CCP/2™ test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the test is "intended for use in clinical laboratories as an in vitro diagnostic test".
- Nature of the Test: The description of the test as detecting and measuring autoantibodies in human serum by ELISA is characteristic of an in vitro diagnostic test, which analyzes samples taken from the human body outside of the body.
N/A
Intended Use / Indications for Use
The TheraTest EL-anti-CCP/2™ test is intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum by enzyme-linked immunosorbent assay (ELISA). It is intended to aid in the diagnosis of Rheumatoid arthritis (RA) in conjunction with other clinical findings and laboratory tests.
Product codes
NHX
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
clinical laboratories
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
AR 0 5 2010
TheraTest Laboratories. Inc. c/o Marius Teodorescu, MD, Ph.D. President & CEO 1111 N Main Street Lombard, IL 60148
Re: K090753
Trade/Device Name: TheraTest EL-anti-CCP/2TM Regulation Number: 21 CFR & 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: Class II Product Code: NHX Dated: March 3, 2010 Received: March 3, 2010
Dear Dr. Teodorescu:
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 class II (Special Controls), 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
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Page 2 - Marius Teodorescu, MD, Ph.D.
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria M. Chan, Ph.D.
Center for Devices and Radiological Health
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Enclosure
2
Indications for Use Statement
TheraTest EL-anti-CCP/2TM
K 090753 510(k)Number
TheraTest EL-anti-CCP/2TM Device Name:
Indications for Use. The TheraTest EL-anti-CCP/2™ test is intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum by enzyme-linked immunosorbent assay (ELISA). It is intended to aid in the diagnosis of Rheumatoid arthritis (RA) in conjunction with other clinical findings and laboratory tests.
Prescription use____X
AND/OR
Over-the-counter use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of in vitro Diagnostic devices (OIVD)
Reena Philip
Division Sign-Off
SIOK
Office of In Vitro Diagnostic Device Evaluation and Safety