VARELISA RECOMBI ANA PROFILE

K993109 · Pharmacia & Upjohn Co. · LJM · Nov 12, 1999 · Immunology

Device Facts

• Record ID: K993109
• Device Name: VARELISA RECOMBI ANA PROFILE
• Applicant: Pharmacia & Upjohn Co.
• Product Code: LJM · Immunology
• Decision Date: Nov 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The Varelisa ReCombi ANA Profile EIA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (Systemic Lupus Erythematosus), Scleroderma (Progressive Systemic Sclerosis), MCTD (Mixed Connective Tissue Disease), SS (Sjögren's Syndrome) and Polymyositis/ Dermatomyositis. The Varelisa ReCombi ANA Profile individually detects antibodies against dsDNA, RNP(68 kDa, A, C), Sm(B,B',D) SS-A/Ro(52 kDa, 60 kDa), SS-B/La, Scl-70, Centromere and Jo-1.

Device Story

Varelisa ReCombi ANA Profile is an enzyme immunoassay (EIA) for qualitative detection of eight specific antinuclear antibodies in human serum or plasma. Device aids clinical diagnosis of systemic rheumatic diseases. Used in clinical laboratory settings by trained personnel. Input is patient serum or plasma sample; device performs immunoassay to detect antibodies against dsDNA, RNP, Sm, SS-A/Ro, SS-B/La, Scl-70, Centromere, and Jo-1. Output is qualitative result for each antibody. Healthcare providers use results to support diagnosis of conditions like SLE, Scleroderma, and Sjögren's Syndrome. Benefits include improved diagnostic specificity for rheumatic autoimmune conditions.

Clinical Evidence

Bench testing only. Correlation study compared subject device to predicate devices using 112 clinical samples (including 20 healthy donors). Results showed 96% overall agreement (107/112 samples). Analysis of 876 individual antibody determinations showed 96% agreement (845/876). Additional validation performed using 10 CDC reference sera (CDC-1 to CDC-10), demonstrating 100% agreement with expected specificities.

Technological Characteristics

Enzyme immunoassay (EIA) for qualitative detection of antinuclear antibodies. Utilizes recombinant antigens for individual detection of eight specific antibodies. Form factor is a multi-well plate kit. Standalone diagnostic test performed in clinical laboratory environment. No software or electronic connectivity described.

Indications for Use

Indicated for qualitative detection of eight antinuclear antibodies (dsDNA, RNP, Sm, SS-A/Ro, SS-B/La, Scl-70, Centromere, Jo-1) in human serum or plasma to aid diagnosis of systemic rheumatic diseases including SLE, Scleroderma, MCTD, Sjögren's Syndrome, and Polymyositis/Dermatomyositis.

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).

Predicate Devices

• Varelisa ANA Profile
• Varelisa dsDNA Antibodies Assay

Reference Devices

• ANA Reference Sera CDC-1 to CDC-10

Submission Summary (Full Text)

{0}------------------------------------------------

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 9.

This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.

| Assigned 510(k) Number: | K993109 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary Preparation: | September 7, 1999 |
| Distributor: | Pharmacia & Upjohn<br>Diagnostics Division, US Operation<br>7425-248-1<br>7000 Portage Road<br>Kalamazoo, MI 49001 |
| Manufacturer: | Pharmacia & Upjohn Diagnostics GmbH Co. KG<br>Munzingerstrasse 7<br>D-79111 Freiburg, Germany |
| Company Contact Person: | Karen E.Matis<br>Manager, Regulatory Affairs and Quality<br>Management<br>Diagnostics Division<br>US Operation<br>7000 Portage Road<br>7425-248-01<br>Kalamazoo, MI 49001<br>[phone] (Phone)<br>[phone] (Fax) |
| Device Name: | Varelisa® ReCombi ANA Profile |
| Common Name: | Antinuclear antibody immunological test |
| Classification: | |

| Product Name | Product Code | Class | CFR |
|-------------------------------|--------------|-------|----------|
| Varelisa® ReCombi ANA Profile | 82LJM | II | 866.5100 |

{1}------------------------------------------------

# Substantial Equivalence to:

Varelisa® ANA Profile and Varelisa® dsDNA Antibodies Assays

### Intended Use Statement:

The Varelisa ReCombi ANA Profile EIA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (Systemic Lupus Erythematosus), Scleroderma (Progressive Systemic Sclerosis), MCTD (Mixed Connective Tissue Disease), SS (Sjögren's Syndrome) and Polymyositis/ Dermatomyositis. The Varelisa ReCombi ANA Profile individually detects antibodies against dsDNA, RNP(68 kDa, A, C), Sm(B,B',D) SS-A/Ro(52 kDa, 60 kDa), SS-B/La, Scl-70, Centromere and Jo-1.

### General Description of the Device

The Varelisa ReCombi ANA Profile is an enzyme immunoassay for the individual qualitative determination of 8 antinuclear antibodies in serum or plasma.

The determination of antinuclear antibodies (ANA) is of central importance for the clinical diagnosis of rheumatic diseases. The presence of ANA suggests the possibility of rheumatic autoimmune diseases. These diseases include Systemic Lupus Erythematosus, Polymyositis/ Dermatomyositis, Scleroderma, Sjögren's Syndrome and Mixed Connective Tissue Diseases.

### Device Comparison:

A correlation study was performed comparing the new device, Varelisa ReCombi ANA Profile Assay, to the predicate devices, Varelisa ANA Profile and Varelisa dsDNA Antibodies Assay. 112 samples, including 20 apparently healthy blood donors were assayed using both tests.

A high degree of correlation is demonstrated in the correlation study. 107 out of 112 samples were found with the same result (96% agreement). Considering the individual parameters, 845 of 876 single determinations (96%) were in agreement between the new device and the predicate devices.

{2}------------------------------------------------

In addition a total agreement is observed when comparing the results obtained for the ANA Reference Sera CDC-1 to CDC-10 from the Centers of Disease Control and Prevention. With both thenew device and predicate devices, all 10 sera were found with the correct specificities.

These data clearly demonstrate that the new device, Varelisa® ReCombi ANA Profile is substantially equivalent to the predicate devices, Varelisa ANA Profile and Varelisa dsDNA Antibodies.

| | n = 876<br>determinations | Varelisa ANA Profile and Varelisa dsDNA Abs. Assay | | |
|------------------------------------|---------------------------|----------------------------------------------------|-----------|----------|
| | | positive | equivocal | negative |
| VARELISA<br>ReCombi<br>ANA Profile | positive | 120 | 7 | 4 |
| | equivocal | 5 | 8 | 5 |
| | negative | 2 | 8 | 717 |

The new device Varelisa® ReCombi ANA Screen shows an excellent correlation with the predicate devices, Varelisa ANA Profile and Varelisa dsDNA Antibodies.

{3}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Nov 1 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Karen E. Matis Manager, Regulatory Affairs and Quality Management Diagnostics Division, US Operations Pharmacia & Upjohn 7000 Portage Road 7425-248-01 Kalamazoo, Michigan 49001-0199

Re: K993109 Trade Name: Varelisa ReCombi ANA Profile Regulatory Class: II Product Code: LJM Dated: September 16, 1999 Received: September 17, 1999

Dear Ms. Matis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Steven Sutman

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

{5}------------------------------------------------

# Varelisa® ReCombi ANA Profile 510(k) Submission Section 1. Indications For Use Statement

510(k) Number: K993109

Device Name: Varelisa ReCombi ANA Profile

The Varelisa ReCombi ANA Profile EIA kit is designed for the qualitative determination of eight antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (Systemic Lupus Erythematosus), Scleroderma (Progressive Systemic Sclerosis), MCTD (Mixed Connective Tissue Disease), SS (Sjögren's Syndrome) and Polymyositis/ Dermatomyositis. The Varelisa ReCombi ANA Profile individually detects antibodies against dsDNA, RNP(68 kDa, A, C), Sm(B,B',D) SS-A/Ro(52 kDa, 60 kDa), SS-B/La, Scl-70, Centromere and Jo-1.

Peter E. Maxim

**(Division Sign-Off)**
Division of Clinical Laboratory Devices K993109
510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:left;">✓</div> |
| OR | |
| Over-The-Counter Use | |

00 00001