ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA

K142781 · Immco Diagnostics, Inc. · LLL · Mar 31, 2015 · Immunology

Device Facts

• Record ID: K142781
• Device Name: ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA
• Applicant: Immco Diagnostics, Inc.
• Product Code: LLL · Immunology
• Decision Date: Mar 31, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

ImmuLisa Enhanced™ SS-A (Ro) Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-A (Ro) (52 kD and 60 kD) IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Sjögren’s Syndrome in conjunction with clinical findings and other laboratory tests. ImmuLisa Enhanced™ SS-B (La) Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-B (La) IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Sjögren’s Syndrome in conjunction with clinical findings and other laboratory tests. ImmuLisa Enhanced™ Sm Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of Sm IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with clinical findings and other laboratory tests. ImmuLisa Enhanced™ RNP Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of RNP IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD) in conjunction with clinical findings and other laboratory tests.

Device Story

Solid-phase ELISA kits for detection of specific IgG autoantibodies in human serum; utilizes antigen-coated microwells; patient serum incubated with antigen; unbound proteins washed; enzyme-labeled anti-human IgG conjugate added; TMB substrate produces color change proportional to antibody concentration; spectrophotometer reads absorbance at 450 nm; results expressed in EU/mL; reported as positive or negative; used in clinical laboratory settings; aids clinicians in diagnosing SLE, Sjögren’s Syndrome, or MCTD alongside clinical findings.

Clinical Evidence

No clinical data provided in the document; substantial equivalence established through bench testing and performance characteristics typical of ELISA-based diagnostic assays.

Technological Characteristics

Solid-phase ELISA; recombinant or purified capture antigens; HRP-conjugated anti-human IgG; TMB substrate; 450 nm spectrophotometric detection; 1:101 screening dilution; semi-quantitative (5-point calibrator) and qualitative reporting; requires microplate reader and washer; no international reference standards; traceable to in-house standards.

Indications for Use

Indicated for qualitative and semi-quantitative detection of IgG autoantibodies (SS-A, SS-B, Sm, RNP) in human serum to aid diagnosis of SLE, Sjögren’s Syndrome, or MCTD. Prescription use only.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 31, 2015

### IMMCO DIAGNOSTICS, INC. MR. KEVIN J. LAWSON VICE PRESIDENT REGULATORY AFFAIRS 60 PINEVIEW DRIVE BUFFALO, NY 14228

Re: k142781

| Trade/Device Name: | ImmuLisa Enhanced™ SS-A (Ro) Antibody ELISA |
|--------------------|------------------------------------------------|
| | ImmuLisa Enhanced™ SS-B (La) Antibody ELISA |
| | ImmuLisa Enhanced™ Sm Antibody ELISA |
| | ImmuLisa Enhanced™ RNP Antibody ELISA |
| Regulation Number: | 21 CFR §866.5100 |
| Regulation Name: | Antinuclear antibody immunological test system |
| Regulatory Class: | Class II |
| Product Code: | LLL, LKP |
| Dated: | February 25, 2015 |
| Received: | February 27, 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 Act include 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

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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); medical device reporting (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 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 regulation (21 CFR Part 801), 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

# Leonthena R. Carrington -A

Leonthena R. Carrington, MS, MBA, MT(ASCP) 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) k142781

Device Name

ImmuLisa Enhanced™ SS-A (Ro) Antibody ELISA

Indications for Use (Describe)

Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-A (Ro) (52 kD and 60 kD) Ig G antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Sjögren's Syndrome in conjunction with clinical findings and other laboratory tests.

| 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

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510(k) Number (if known) k142781

Device Name

ImmuLisa Enhanced™ SS-B (La) Antibody ELISA

Indications for Use (Describe)

Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-B (La) IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Sjögren's Syndrome in conjunction with clinical findings and other laboratory tests.

Type of Use (Select one or both, as applicable)

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

{4}------------------------------------------------

510(k) Number (if known) k142781

Device Name

ImmuLisa Enhanced™ Sm Antibody ELISA

Indications for Use (Describe)

Enzyme linked immunoassay (ELISA) for the qualitative detection of Sm IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with clinical findings and other laboratory tests.

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> |

### 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) k142781

Device Name

ImmuLisa Enhanced™ RNP Antibody ELISA

#### Indications for Use (Describe)

Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of RNP IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD) in conjunction with clinical findings and other laboratory tests.

| 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