AUTOSTAT II ANTI-SM ELISA

K990625 · Cogent Diagnotics , Ltd. · LKP · Apr 28, 1999 · Immunology

Device Facts

• Record ID: K990625
• Device Name: AUTOSTAT II ANTI-SM ELISA
• Applicant: Cogent Diagnotics , Ltd.
• Product Code: LKP · Immunology
• Decision Date: Apr 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Sm in human serum. Uses: The results of the anti-Sm assay can be used as an aid in the diagnosis of auto-immune diseases including Systemic Lupus Erythematosus (SLE). For in vitro diagnostic use only.

Device Story

Autostat™ II Anti-Sm ELISA is an in vitro diagnostic test for detecting IgG autoantibodies to Sm in human serum. The device utilizes an enzyme-linked immunosorbent assay (ELISA) method. It is intended for use by clinical laboratory professionals to aid in the diagnosis of auto-immune diseases, specifically Systemic Lupus Erythematosus (SLE). The assay provides semi-quantitative results, which healthcare providers use in conjunction with clinical evaluation to support diagnostic decision-making.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for detection of IgG autoantibodies. In vitro diagnostic device. No specific materials, software, or connectivity details provided.

Indications for Use

Indicated for semi-quantitative determination of IgG autoantibodies to Sm in human serum as an aid in the diagnosis of auto-immune diseases, including Systemic Lupus Erythematosus (SLE). For in vitro diagnostic use.

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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Public Health Service

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APR 2 8 1999

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Danielle M. Knight Quality Manager Cogent Diagnostics Limited Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom

Re: K990625 Trade Name: Autostat™ II Anti-Sm ELISA Regulatory Class: II Product Code: LKP Dated: February 16, 1999 Received: February 25, 1999

Dear Ms. Knight:

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/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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Page__________________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | K 990635 |
|---------------------------|------------------|
| Device Name: | AutostatⅡAnti-Sm |

## Indications for Use.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Sm in human serum.

Uses:

The results of the anti-Sm assay can be used as an aid in the diagnosis of auto-immune diseases including Systemic Lupus Erythematosus (SLE).

For in vitro diagnostic use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Malcomi

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

K-990625

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)