LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206

K984462 · Bio-Rad · LLL · Dec 22, 1998 · Immunology

Device Facts

• Record ID: K984462
• Device Name: LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206
• Applicant: Bio-Rad
• Product Code: LLL · Immunology
• Decision Date: Dec 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

Liquichek ENA Control, EIA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of extractable nuclear antigen (ENA) autoantibodies.

Device Story

Liquichek ENA Control, EIA Screen is an in vitro diagnostic quality control product used in clinical laboratories to monitor the performance of enzyme immunoassay (EIA) procedures. The device is prepared from human serum supplemented with preservatives (0.1% sodium azide) and stabilizers. It is provided in a liquid form, ready for use, and is stored at 2-8°C. The control is available in negative, positive, and high-positive levels. Laboratory technicians use this control alongside patient samples during routine testing to verify the accuracy and precision of the EIA screening process for ENA autoantibodies. By comparing the observed results of the control against expected ranges, the laboratory can ensure the reliability of the assay, thereby supporting the clinical assessment of patients suspected of having systemic rheumatic diseases.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid human serum-based control containing 0.1% sodium azide as a preservative and added stabilizers. Provided in negative, positive, and high-positive levels. Storage at 2-8°C. Open vial shelf life of 30 days.

Indications for Use

Indicated for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of extractable nuclear antigen (ENA) autoantibodies in clinical laboratory settings.

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

• Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit (K954723)

Submission Summary (Full Text)

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DEC 22 1998

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Laboratories

ornia 92618-2 hone: (949) 598-12

984462

# 510(k) Summary

Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation December 14, 1998

Jevice (Trade & Common Name) Liquichek ENA Control, EIA Screen

Classification Name Class II, 82LLL CFR 866.5100: Extractable Antinuclear Antibody, Antigen and Control.

Devices to Which Substantial Equivalence is Claimed Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit Helix Diagnostics West Sacrament, California K954723

#### Statement of Intended Use

Liquichek ENA Control, ElA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of extractable nuclear antigen (ENA) autoantibodies.

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Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: [phone]

### Description of the Device

Liquichek ENA Control, EIA Screen is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

Statement of How Technological Characteristics Compare to Substantial Equivalent Device A table is provided below comparing the similarities between the Bio-Rad Liquichek ENA Control, EIA Screen and the device to which substantial equivalence is claimed.

| | Helix Enzyme Immunoassay Antinuclear<br>Antibody Screening Test Kit | Bio-Rad Liquichek ENAControl,<br>EIA Screen |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A qualitative enzyme immunoassay (EIA) for<br>screening the presence of antinuclear<br>antibodies (ANAs) in human serum as an aid<br>in the diagnosis of certain systemic rheumatic<br>diseases. | An unassayed quality control<br>serum for monitoring enzyme<br>immunoassay procedures for<br>the screening of extractable<br>nuclear antigen (ENA)<br>autoantibodies. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Negative, Positive, Cutoff | Negative, Positive, High Positive |
| Storage | 2-8°C | 2-8°C |
| Analytes | Total ANAs against:<br>DNA (dsDNA, nDNA)<br>Histones<br>SS-A/Ro<br>SS-B/La<br>Sm<br>SmRNP<br>Scl-70<br>Jo-1<br>Centrometric antigens<br>Sera positive for Immunofluorescent<br>(IFA) Hep-2 ANAs | ENA |
| Open Vial<br>Claim | Shelf life | 30 Days at 2-8°C |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 22 1998

Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K984462 Trade Name: Liquichek ENA Control, EIA Screen Regulatory Class: II Product Code: LLL Dated: December 14, 1998 Received: December 16, 1998

Dear Ms. Platt:

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 aqainst 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 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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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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198440 510(k) Number: Device Name: Liquichek ENA Control, EIA Screen

Indications for Use:

Liquichek ENA Control, EIA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of extractable nuclear antigen (ENA) autoantibodies.

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(Concurrence of CDRH, Office of Device Evaluation)
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K984462 |
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| Prescription Use | <img alt="checkmark" src="checkmark.png"/> | OR | Over-The Counter Use |
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