(23 days)
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No
The provided text describes a standard ELISA test, which is a laboratory technique and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is an in-vitro diagnostic (IVD) test intended to aid in the diagnosis of Rheumatoid Arthritis by detecting autoantibodies. It does not directly treat or prevent a disease, which is characteristic of therapeutic devices.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "The test is intended to aid in the diagnosis of Rheumatoid Arthritis (RA)".
No
The device description clearly states it is an enzyme-linked immunosorbent assay (ELISA), which is a laboratory test involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- It is an assay performed in vitro (outside the body): The description explicitly states it's an "enzyme-linked immunosorbent assay (ELISA)" for detecting antibodies in "human serum or plasma." These are samples taken from the body and tested in a laboratory setting.
- It is intended for diagnostic purposes: The "Intended Use / Indications for Use" section clearly states the test is "intended to aid in the diagnosis of Rheumatoid Arthritis (RA)."
These two points are the core characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diastat™Anti-CCP test is a semi-quantitative/ qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma. The test is intended to aid in the diagnosis of Rheumatoid Arthritis (RA) and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.
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
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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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§ 866.5775 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
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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 0 9 2002
Ms. Eileen McCafferty Regulatory Affairs Manager Axis-Shield Diagnostics Lune Place The Technology Park Dundee DD2 1XA SCOTLAND
Re: K023285
Trade/Device Name: Diastat™ Anti-Cyclic Citrullinated Peptide (anti-CCP) ELISA Regulation Number: 21 CFR § 866.5775 Regulation Name: Rhematoid Factor Immunological Test System Regulatory Class: II Product Code: NHX Dated: September 13, 2002 Received: September 16, 2002
Dear Ms. McCafferty:
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
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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 Butman
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
INDICATIONS FOR USE
510(k) number if known: k 023285
Device Name: Diastat™Anti-Cyclic Citrullinated Peptide (anti-CCP) ELISA
Indications for Use: The Diastat™Anti-CCP test is a semi-quantitative/ qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma. The test is intended to aid in the diagnosis of Rheumatoid Arthritis (RA) and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Concurrence of CDRH, Office of Device evaluation (ODE)
.. OR
Prescription Use ............ Per 21 CFR 801. 109
Over- the -Counter - Use .....................................................................................................................................................
Optional format 1 -- 2 - 96
Deboral M. Moore
(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number_KO23285