LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112

K024222 · Bio-Rad · DHN · Jan 15, 2003 · Immunology

Device Facts

• Record ID: K024222
• Device Name: LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
• Applicant: Bio-Rad
• Product Code: DHN · Immunology
• Decision Date: Jan 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The new Liquichek™ ANA Control, Centromere Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

Device Story

Liquichek™ ANA Control, Centromere Pattern, Positive is a human serum-based quality control material; used to monitor performance of indirect immunofluorescent assays for antinuclear antibodies (ANA). Device provided in liquid form; stored at 2-8°C. Laboratory personnel use the control to verify assay accuracy and precision; results help ensure reliability of patient testing. Stability data supports 60-day open-vial stability and 2-year shelf life.

Clinical Evidence

Bench testing only. Stability studies were conducted to validate open-vial stability (60 days) and shelf life (2 years) when stored at 2-8°C.

Technological Characteristics

Human serum-based control with added preservatives. Liquid form. Storage at 2-8°C. Unassayed quality control material.

Indications for Use

Indicated for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA) 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

• Liquichek™ ANA Control, Centromere Pattern (K984397)

Submission Summary (Full Text)

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# K024222

### Summary of Safety and Effectiveness Liquichek™ ANA Control, Centromere Pattern, Positive

#### 1.0 Submitter

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

JAN 1 5 2003

### 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™ ANA Control Speckled Pattern, Positive |
|---------------------|--------------------------------------------------------------------|
| Common Name: | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Classifications: | Class II |
| Product Code: | 82DHN |
| Regulation Number: | 21 CFR 866.5100 |

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

Liquichek™ ANA Control, Centromere Pattern Bio-Rad Laboratories

510 (k) Number: K984397

#### 4.0 Description of Device

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

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#### Statement of Intended Use 5.0

The new Liquichek™ ANA Control, Centromere Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

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

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

Liquichek™ ANA Control, Centromere Pattern Bio-Rad Laboratories

510 (k) Number: K984397

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

| Characteristics | Liquichek™ ANA Control,<br>Centromere Pattern, Positive<br>(New Device) | Liquichek™ ANA Control,<br>Centromere Pattern<br>(Predicate Device) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The new Liquichek™ ANA<br>Control, Centromere Pattern,<br>Positive, is intended for use as an<br>unassayed quality control to<br>monitor indirect<br>immunofluorescent testing of<br>antinuclear antibodies (ANA). | The Liquichek™ ANA Control,<br>Centromere Pattern is intended for<br>use as an unassayed quality<br>control to monitor indirect<br>immunofluorescent testing of<br>antinuclear antibodies (ANA). |
| 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 | ANA Centromere Pattern | ANA Centromere Pattern |

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| Differences | | |
|-----------------------|-----------------------------------------------------|-----------------------------------------------------|
| Stability<br>(Opened) | Once opened the analyte will be stable for 60 days. | Once opened the analyte will be stable for 30 days. |

#### 7.0 Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ ANA Control Centromere Pattern, 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JAN 1 5 2003

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

Re: k024222

Trade/Device Name: Liquichek™ ANA Control, Centromere Pattern, Positive Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: DHN 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).

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### Page 2 -

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.

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). Other general information on your responsibilities under the Act may be obtained 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 Butman

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): k024222

Device Name: Liquichek™ ANA Control, Centromere Pattern, Positive

Indications for Use:

The new Liquichek™ ANA Control, Centromere Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use V or

Over-the Counter use

J.P. Reeves for J. Bautista
Division Sign Off

Division of Clinical Laboratory Devices

10(k) Number_(c 0 2 צלי ר' 10)10