← Product Code [LLL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL) · K983464

# THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983464)

_Zeus Scientific, Inc. · LLL · Nov 18, 1998 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL/K983464

## Device Facts

- **Applicant:** Zeus Scientific, Inc.
- **Product Code:** [LLL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL.md)
- **Decision Date:** Nov 18, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5100
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Intended Use

The Jo-1 ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies Jo-1.

## Device Story

Aptus (Automated) Application for the Jo-1 ELISA Test System is an in vitro diagnostic device used to detect IgG autoantibodies to Jo-1 in human serum. The system supports both manual and automated analysis workflows. It is intended for use by laboratory professionals to assist in the diagnostic evaluation of patients suspected of having connective tissue diseases. The device processes serum samples to identify the presence or absence of specific autoantibodies, providing clinical information that aids healthcare providers in the diagnostic work-up of autoimmune conditions.

## Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the device's intended use and performance characteristics as an ELISA test system for Jo-1 antibodies.

## Technological Characteristics

ELISA (Enzyme-Linked Immunosorbent Assay) test system for the detection of IgG antibodies. Supports manual or automated processing of human serum samples. Classified as Class II, Product Code LLL.

## Regulatory 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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NOV 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mark J. Kopnitsky Vice President of Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, New Jersey 08876

Re : K983464 Aptus (Automated) Application for the Jo-1 Test Trade Name: System Regulatory Class: II Product Code: LLL Dated: September 30, 1998 Received: October 1, 1998

Dear Mr. Kopnitsky:

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 Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

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510(k) Number (if known): 598

Device Name: Aptus (automated) Application for the Jo-1 ELISA Test System

Indications for Use:

The presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases.

The Jo-1 ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies Jo-1.

Pitur E. Malini

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Optional Format 1-

(Per 21 CFR 801,109)

2-96)

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