LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209

K984470 · Bio-Rad · LKJ · Dec 22, 1998 · Immunology

Device Facts

• Record ID: K984470
• Device Name: LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
• Applicant: Bio-Rad
• Product Code: LKJ · Immunology
• Decision Date: Dec 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

Liquichek Anti-SS-A Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of SS-A autoantibodies.

Device Story

Liquichek Anti-SS-A Control, EIA is an in vitro diagnostic quality control product; prepared from human serum with added preservatives (0.1% sodium azide) and stabilizers. Provided in liquid form for laboratory use. Device serves as a control to monitor performance of enzyme immunoassay (EIA) procedures for detecting SS-A autoantibodies. Laboratory personnel use the control alongside patient samples to verify assay accuracy and precision. Output is a qualitative or semi-quantitative check of assay performance; helps clinicians ensure reliability of patient test results for systemic rheumatic disease diagnosis.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid human serum matrix; contains 0.1% sodium azide preservative. Storage at 2-8°C. Open vial stability claim of 30 days at 2-8°C. Non-automated, manual quality control reagent.

Indications for Use

Indicated for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of SS-A 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)

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

DEC 2 2 398

Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits and letters. The sequence appears to be 'K984470'. The characters are written in a bold, somewhat rough style, giving them a distinct and easily readable appearance. The contrast between the characters and the background is high, making the sequence stand out.

Image /page/0/Picture/2 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. The text is in all caps and bolded.

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

## 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

Device (Trade & Common Name) Liquichek Anti-SS-A Control, EIA

Classification Name Class II, 82LKJ CFR 866.5100: Antinuclear Antibody, Antigen, 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 Anti-SS-A Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of SS-A autoantibodies.

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

Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black background. The text is in a bold, sans-serif font.

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

## Description of the Device

Liquichek Anti-SS-A Control, EIA 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 Liguichek Anti-SS-A, EIA and the device to which substantial equivalence is claimed.

| | Helix Enzyme Immunoassay Antinuclear<br>Antibody Screening Test Kit | Bio-Rad Liquichek Anti-SS-A<br>Control, EIA |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 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 detection of SS-A<br>autoantibodies. |
| orm | 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 | Anti-SS-A |
| Open Vial<br>Claim | Shelf life | 30 Days at 2-8°C |

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

Image /page/2/Picture/2 description: The image shows a partial view of a logo or emblem, likely from a government department. The visible portion includes a stylized graphic element consisting of three curved, parallel lines that resemble a simplified representation of waves or a flowing object. To the left of the graphic, part of the text "DEPARTMENT OF" is visible, suggesting the complete logo includes the full name of the department.

DEC 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K984470 Re: Trade Name: Liquichek ANA-SS-A Control, EIA Model #209 Regulatory Class: II Product Code: LKJ Dated: December 14, 1998 December 16, 1998 Received:

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 Requlation (QS) for Medical Devices: General requlation (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.

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

## Paqe 2

This letter will allow you to beqin 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 Putman

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

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

Page 1 of 1

Rage 20 510(k) Number: Device Name: Liquichek Anti-SS-A Control, EIA

Indications for Use:

Liquichek Anti-SS-A Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Anti-SS-A autoantibodies.

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

(Concurrence of CDRH, Office of Device Evaluation)

(Division Sign-Off)

| Division of Clinical Laboratory Devices | K984470 |
|-----------------------------------------|---------|
| 510(k) Number | |

| Prescription Use | <div></div> |
|------------------|-------------|
|------------------|-------------|

OR Over-The Counter Use