(267 days)
None
Not Found
No
The summary describes an ELISA assay, which is a standard laboratory technique and does not mention any AI or ML components.
No.
This device is an immunoassay intended for diagnostic purposes (detection of Rheumatoid Factor antibodies), not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is designed "to aid in the diagnosis of rheumatoid arthritis (RA)".
No
The device description is not found, but the intended use clearly describes an Enzyme Linked Immunoassay (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:
- Intended Use: The intended use clearly states that the device is an "Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor... antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA)". This indicates that the device is used to examine specimens derived from the human body (serum) to provide information for diagnostic purposes.
- Method: The method described is an "Enzyme linked immunoassay (ELISA)", which is a common in vitro diagnostic technique.
- Specimen Type: The device uses "human serum", which is a biological specimen taken from the human body.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of human tissues, organs or blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Product codes
DHR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 14, 2021
IMMCO Diagnostics, Inc. Kevin Lawson VP Regulatory Affairs 9870 Hollingson Rd Clarence, New York 14031
Re: K143736
Trade/Device Name: ImmuLisa Enhanced RF IgA Antibody ELISA ImmuLisa Enhanced RF IgG Antibody ELISA ImmuLisa Enhanced RF IgM Antibody ELISA ImmuLisa Enhanced RF Antibody Screen ELISA Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: Class II Product Code: DHR
Dear Kevin Lawson:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on September 23, 2015. Specifically, FDA is updating this SE letter due to the clearance date not appearing on the original letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ying Mao, OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-6635, Ying.Mao@fda.hhs.gov.
Sincerely,
Ying Mao -S
Ying Mao, Ph.D. Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
IMMCO Diagnostics, Inc. Mr. Kevin Lawson Vice President of Regulatory Affairs 9870 Hollingson Road Clarence, NY 14031
Re: K143736 Trade/Device Name: ImmuLisa Enhanced™ RF IgA Antibody ELISA ImmuLisa Enhanced™ RF IgG Antibody ELISA ImmuLisa Enhanced™ RF IgM Antibody ELISA ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISA Regulation Number: 21 CFR §866.5775 Regulation Name: Rheumatoid factor immunologica1 test system Regulatory Class: II Product Code: DHR Dated: September 15, 2015 Received: September 16, 2015
Dear Mr. Lawson:
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 Actinclude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
2
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kelly Oliner -S / 2015.09.23 16:57:42 -04'00'
FOR
Leonthena Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known) K143736
Device Name ImmuLisa Enhanced™ RF IgA Antibody ELISA
Indications for Use (Describe)
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known) K143736
Device Name ImmuLisa Enhanced™ RF IgG Antibody ELISA
Indications for Use (Describe)
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K143736
Device Name
ImmuLisa Enhanced™ RF IgM Antibody ELISA.
Indications for Use (Describe)
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K143736
Device Name
ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA.
Indications for Use (Describe)
Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov