ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA

K143736 · Immco Diagnostics, Inc. · DHR · Sep 23, 2015 · Immunology

Device Facts

• Record ID: K143736
• 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
• Applicant: Immco Diagnostics, Inc.
• Product Code: DHR · Immunology
• Decision Date: Sep 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

ImmuLisa Enhanced™ RF IgA Antibody ELISA: 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. ImmuLisa Enhanced™ RF IgG Antibody ELISA: 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. ImmuLisa Enhanced™ RF IgM Antibody ELISA: 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. ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA: 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.

Device Story

ImmuLisa Enhanced™ RF Antibody ELISAs are sandwich-type enzyme immunoassays for detecting Rheumatoid Factor (RF) antibodies in human serum. The device uses microplates coated with purified rabbit IgG antigen. Patient serum samples are incubated in the wells; if RF antibodies are present, they bind to the antigen. After washing, HRP-conjugated anti-human immunoglobulins (IgA, IgG, IgM, or a mixture) are added. A TMB substrate is introduced, producing a color change proportional to the antibody concentration, measured by a spectrophotometer at 450 nm. The device is used in clinical laboratory settings by trained personnel. Results are reported as qualitative or semi-quantitative (EU/mL or IU/mL) to assist clinicians in diagnosing rheumatoid arthritis. The test provides diagnostic support when used alongside other clinical findings and laboratory tests.

Clinical Evidence

Clinical performance was evaluated using 179–249 clinically characterized RA samples and 310 disease controls. Sensitivity ranged from 39.4% to 84.9% and specificity from 85.5% to 94.8% depending on the specific isotype and cut-off interpretation. Method comparison against predicate devices showed overall percent agreement ranging from 79.7% to 96.3%. Cross-reactivity was assessed across 310 samples from various autoimmune and infectious diseases.

Technological Characteristics

Sandwich-type ELISA; rabbit IgG capture antigen; HRP-conjugated anti-human IgA, IgG, or IgM detection reagents; TMB substrate; sulfuric acid stop solution. Requires microplate reader (450 nm) and automatic washer. Qualitative and semi-quantitative modes. Traceable to in-house standards (IgA/IgG) or WHO NIBSC 64/2 (IgM).

Indications for Use

Indicated for the qualitative or semi-quantitative detection of Rheumatoid Factor (RF) IgA, IgG, or IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. For prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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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, [e-mail].

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

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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)

| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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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)

| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### 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) | |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### 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