MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM

K993971 · Micro Detect, Inc. · LLL · Jan 11, 2000 · Immunology

Device Facts

• Record ID: K993971
• Device Name: MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM
• Applicant: Micro Detect, Inc.
• Product Code: LLL · Immunology
• Decision Date: Jan 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The MDI SS-B Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human SS-B in human serum The test is intended as an aid in the diagnosis of rheumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.

Device Story

MDI SS-B Test is a manual Enzyme Immunoassay (EIA) kit; utilizes microplate coated with specific antigens to detect IgG autoantibodies to SS-B in human serum samples. Procedure involves incubation with patient serum, wash buffer, conjugate, substrate, and stop solution. Designed for clinical laboratory use; results interpreted by healthcare providers to aid in the diagnosis of rheumatic diseases. Provides semi-quantitative determination of antibody levels; assists in clinical assessment of autoimmune conditions.

Clinical Evidence

Performance evaluation based on comparative testing against predicate assays. Reported relative sensitivity of 94.6% and relative specificity of 97.7%. Precision testing showed inter-assay CV of 2.11-4.68% and intra-assay CV of 1.88-5.99%. Stability testing conducted under stress conditions (37°C) and real-time monitoring.

Technological Characteristics

Microplate ELISA format; manual procedure. Components include antigen-coated microplate, wash buffer, sample diluent, conjugate, substrate, and stop solution. Stability: 1 year at 2-8°C.

Indications for Use

Indicated for the semi-quantitative detection of IgG autoantibodies against SS-B in human serum as an aid in the diagnosis of rheumatic diseases.

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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# ATTACHMENT D

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### SUMMARY OF 510 (k) SAFETY AND EFFECTIVENESS INFORMATION

This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.

MDI SS-B Test reagents (P/N; SBKi-G) are intended for the semi-quantitative determination of IgG antibodies to SS-B in human serum. The principal diagnostic value of this test is detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases.

The Micro Detect, Inc. SS-B reagent ( MDI SS-B Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls. Wash Buffer. Sample Diluent, Conjugate, Substrate, and Stop Solution.

The patient results obtained using the MDI SS-B Test is substantially equivalent to those obtained by using predicate assays:

Relative Sensitivity: 94.6% Relative Specificity: 97.7 %

Precision (%CV): 2.11-4.68(Inter) and 1.88-5.99(Intra)

Stability: One year at 2-8°C. The stability of the MDI SS-B Test Kit for the detection of IgG antibodies to SS-B was found to be one year at 2-8°C. This was predicted from studies done under stress condition (37°C). Real time stability has only been monitored for ten weeks at 2-8°C.

The Micro plate ELISA formats is a commonly used format for the detection of many entities of clinical interest, including autoimmune diseases.

The MDI SS-B Test system is shown to be safe and effective and provide results, which are substantially equivalent to those, obtained by predicate products.

SS-B

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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

## 'JAN 1 1 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mehdi Alem, Ph.D. President Micro Detect, Inc. 2852 Walnut Avenue Suite H-1 Tustin, California 92780

K993971 Re:

> Trade Name: MDI SS-B Test Regulatory Class: II Product Code: LLL Dated: December 21, 1999 Received: December 27, 1999

Dear Dr. Alem:

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 (QS) 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.

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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/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Steven Dutman

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

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K953971/A'

Page 1 of 1

### 510(k) Number (if known): K993971

Device Name: MDI SS-B Test

### Indications For Use:

The MDI SS-B Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human SS-B in human serum The test is intended as an aid in the diagnosis of rheumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Mafini

(Division Sign-Off) Division of Clinical Laboratory Devic 510(k) Number

Prescription Use k (Per 21 CFR 801,109)

OR

Over-The-Counter Use

(Optional Format 1-2 -96)