(140 days)
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Not Found
No
The summary describes a standard ELISA assay for detecting antibodies, with no mention of AI or ML in the intended use, device description, or any other section.
No
The device is an in vitro diagnostic assay used for aiding in the diagnosis of rheumatoid arthritis by detecting specific antibodies, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section states that the assay "is an aid in the diagnosis of rheumatoid arthritis (RA)".
No
The device is an ELISA kit, which is a laboratory test involving physical reagents and equipment, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "enzyme-linked immunosorbent assay for the detection of IgG and IgA anti-CCP3 (Cyclic Citrullinated Peptide 3) antibodies in patient sera or citrated or EDTA plasma." This involves testing biological samples in vitro (outside the body).
- Purpose: The purpose is to aid in the diagnosis of rheumatoid arthritis (RA). This is a diagnostic purpose, which is a key characteristic of IVDs.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
The QUANTA Lite™ CCP3.1 IgG/IgA ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG and IgA anti-CCP3 (Cyclic Citrullinated Peptide 3) antibodies in patient sera or citrated or EDTA plasma. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis (RA), including RA diagnosed within 2 years of presentation of symptoms.
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)
Not Found
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
Not Found
§ 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
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is made up of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR - 5 2008
c/o Dr. Rufus Burlingame Senior Scientist 9900 Old Grove Rd. San Diego, CA 92131-1638
INOVA Diagnostics, Inc.
Re: K072944
Trade/Device Name: QUANTA Lite™ CCP 3.1 IgG/IgA ELISA Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: Class II Product Code: NHX Dated: February 21, 2008 Received: February 26, 2008
Dear Dr. Burlingame:
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. Iisting 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert Becker/
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K072944
Device Name: QUANTA Lite™ CCP3.1 IgG/IgA ELISA
Indications For Use:
The QUANTA Lite™ CCP3.1 IgG/IgA ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG and IgA anti-CCP3 (Cyclic Citrullinated Peptide 3) antibodies in patient sera or citrated or EDTA plasma. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis (RA), including RA diagnosed within 2 years of presentation of symptoms.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X_
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Mana M Chor
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072944
(Optional Format 1-2-96)
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