LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113

K024232 · Bio-Rad · LKJ · Jan 17, 2003 · Immunology

Device Facts

• Record ID: K024232
• Device Name: LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
• Applicant: Bio-Rad
• Product Code: LKJ · Immunology
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The Liquichek™ Anti-SS-B Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-B autoantibodies.

Device Story

Liquichek™ Anti-SS-B Control, Positive is an unassayed quality control material derived from human serum with added preservatives. It is provided in liquid form for use in clinical laboratories. The device serves as a control to monitor the performance of indirect immunofluorescent testing for SS-B autoantibodies. Laboratory personnel use the control to verify the accuracy and reliability of the testing process. By comparing results obtained from the control against expected values, clinicians can ensure the validity of patient test results, thereby supporting accurate diagnosis and management of autoimmune conditions associated with SS-B autoantibodies.

Clinical Evidence

No clinical data. Stability studies were performed to validate shelf life (2 years at 2-8°C) and open-vial stability (60 days at 2-8°C).

Technological Characteristics

Human serum matrix with added preservatives. Liquid form. Unassayed. Storage at 2°C to 8°C. Open-vial stability of 60 days; shelf life of 2 years.

Indications for Use

Indicated for use as an unassayed quality control material to monitor the performance of indirect immunofluorescent testing procedures for the detection of SS-B autoantibodies in human serum samples.

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

• Liquichek™ Anti-SS-B Control, EIA (K984478)

Submission Summary (Full Text)

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K024232

## Summary of Safety and Effectiveness Liquichek™ Anti-SS-B Control, Positive

#### 1.0 Submitter

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

# Contact Person

Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: [phone]

# Date of Summary Preparation

December 20, 2002

#### 2.0 Device Identification

| Product Trade Name: | Liquichek™ Anti-SS-B Control, Positive |
|---------------------|-------------------------------------------|
| Common Name: | Antinuclear Antibody, Antigen and Control |
| Classifications: | Class II |
| Product Code: | 82LKJ |
| Regulation Number: | 21 CFR 866.5100 |

#### 3.0 Device to Which Substantial Equivalence is Claimed

Liquichek™ Anti-SS-B Control, EIA Bio-Rad Laboratories

510 (k) Number: K984478

#### 4.0 Description of Device

This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.

JAN 1 7 2003

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#### 5.0 Statement of Intended Use

The Liquichek™ Anti-SS-B Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-B autoantibodies..

#### 6.0 Comparison of the new device with the Predicate Device

This control is substantially equivalent to the following quality control material for autoimmune analysis that is currently in the market:

Liquichek™ Anti-SS-B Control, EIA Bio-Rad Laboratories

510 (k) Number: K984478

Table 1. Similarities and Differences between new and predicate device.

| Characteristics | Liquichek™ Anti-SS-B Control, Positive<br>(New Device) | Liquichek™ Anti-SS-B Control, EIA<br>(Predicate Device) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Similarities</b> | | |
| Matrix | Human Serum | Human Serum |
| Storage<br>(Unopened) | 2°C to 8°C<br>until expiration date | 2°C to 8°C<br>until expiration date |
| Form | Liquid | Liquid |
| Analyte | Anti-SS-B | Anti-SS-B |
| Value Assignment | Unassayed | Unassayed |
| <b>Differences</b> | | |
| Intended Use | The Liquichek™ Anti-SS-B Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-B autoantibodies. | The Liquichek™ Anti-SS-B Control, EIA is intended for use as an unassayed quality control to monitor enzyme ummunoassay procedures for the detection of SS-B autoantibodies. |
| Stability<br>(Opened) | Once opened the analyte will be stable for 60 days | Once opened the analyte will be stable for 30 days |

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#### 7.0 Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Liguichek™ Anti-SS-B Control, Positive. Product claims are as follows:

- Once the control is opened the analyte will be stable for 60 days when 7.1 stored tightly capped at 2 to 8°C.
- 7.2 The control is stable for 2 years when stored unopened at 2 8°C.

Real time studies will be ongoing to support the shelf life of this product.

All supporting data is retained on file at Bio-Rad Laboratories.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three profiles facing right, representing the department's focus on people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" forming the outer circle and "USA" positioned at the top.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories, OSD 9500 Jeronimo Road Irvine, California 92618-2017

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JAN 1 7 2003

Re: k024232

> Trade/Device Name: Liquichek™ Anti-SS-B Control. Positive Regulation Number: 21 CFR & 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: II Product Code: LKJ Dated: December 20, 2002 Received: December 23, 2002

Dear Ms. Lloyd:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): __ Koay &33-

Device Name: Liquichek™ Anti-SS-B Control, Positive

Indications for Use:

Liquichek Anti-SS-B Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-B autoantibodies.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use or

Over-the Counter use

J. Reeves for J. Bautista

(Division Sign-Off) (Shoron of Clinical Laboratory Dexices 2 2 KU 510(k) Number ________________________________________________________________________________________________________________________________________________________________