LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131

K024230 · Bio-Rad · DHN · Jan 15, 2003 · Immunology

Device Facts

• Record ID: K024230
• Device Name: LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131
• 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 Liquichek ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns, is intended for use as an unassayed quality control set to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

Device Story

Liquichek ANA Controls Set consists of human serum-based liquid controls containing specific antinuclear antibody (ANA) patterns: homogeneous, speckled, centromere, and nucleolar. Used in clinical laboratories to monitor the performance of indirect immunofluorescent (IIF) assays for ANA detection. Controls are provided as unassayed materials; laboratory personnel use them to verify the accuracy and precision of the testing process. By comparing observed results against expected patterns, clinicians ensure the reliability of patient autoantibody testing, aiding in the diagnosis of autoimmune conditions.

Clinical Evidence

No clinical data. Performance is supported by bench testing, specifically stability studies confirming 60-day open-vial stability and 2-year shelf life when stored at 2-8°C.

Technological Characteristics

Liquid human serum-based control set. Contains preservatives. Four distinct ANA patterns: homogeneous, speckled, centromere, and nucleolar. Storage: 2°C to 8°C. Unassayed quality control material.

Indications for Use

Indicated for use as an unassayed quality control set 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

• Kallestad™ ANA Positive Control Homogeneous Pattern (K792610)
• Liquichek™ ANA Control, Centromere Pattern (K984397)
• Kallestad™ Autoantibody Positive Control (K792610)

Submission Summary (Full Text)

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K024230

## Summary of Safety and Effectiveness

Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns

#### 1.0 Submitter

JAN 1 5 2003

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™ ANA Controls Set, Positive:<br>Homogeneous, Speckled, Centromere, and Nucleolar<br>Patterns |
|---------------------|--------------------------------------------------------------------------------------------------------|
| Common Name: | Antinuclear Antibody, Indirect Immunofluorescent,<br>Antigen, Control |
| Classifications: | Class II |
| Product Code: | 82DHN |
| Regulation Number: | 21 CFR 866.5100 |

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

- . Kallestad™ ANA Positive Control Homogeneous Pattern Bio-Rad Laboratories
510 (k) Number: K792610

- 川. Liquichek™ ANA Control, Centromere Pattern Bio-Rad Laboratories
510 (k) Number: K984397

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### III. Kallestad ™ Autoantibody Positive Control Bio-Rad Laboratories

510 (k) Number: K792610

#### 4.0 Description of Device

These products are prepared from human serum with added preservatives. These controls are provided in liquid form for convenience

#### 5.0 Statement of Intended Use

The new Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns, is intended for use as an unassayed quality control set to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

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

The controls in the set are substantially equivalent to the following quality control materials for autoimmune analyses that is currently in the market:

- Kallestad ™ ANA Positive Control Homogeneous Pattern ﺎ . Bio-Rad Laboratories
510 (k) Number: K792610

- II. Liquichek™ ANA Control, Centromere Pattern Bio-Rad Laboratories
510 (k) Number: K984397

- III. Kallestad TM Autoantibody Positive Control Bio-Rad Laboratories
510 (k) Number: K792610

Tables 1-3 (below) contains comparison information of similarities and differences between the new Liquichek ™ ANA Controls Set, Positive: Homogeneous. Speckled, Centromere, and Nucleolar Patterns and the currently Kallestad™ ANA Positive Control Homogeneous Pattern, Liquichek™ ANA Control. Centromere Pattern, and Kallestad™ Autoantibody Positive Control to which substantial equivalence is claimed.

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Table 1. Similarities and Differences between new and predicate device

Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns and Kallestad™ ANA Positive Control Homogeneous Pattern

| Characteristics | Liquichek™ ANA Controls Set,<br>Positive: Homogeneous,<br>Speckled, Centromere, and<br>Nucleolar Patterns<br>(New Device) | Kallestad™ ANA Positive Control<br>Homogeneous Pattern<br>(Predicate Device) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The Liquichek ANA Controls Set,<br>Positive: Homogeneous,<br>Speckled, Centromere, and<br>Nucleolar Patterns, is intended for<br>use as an unassayed quality<br>control set to monitor indirect<br>immunofluorescent testing of<br>antinuclear antibodies (ANA). | The intended use of the ANA<br>Positive Control Homogeneous<br>Pattern is the quality control of<br>indirect fluorescent antibody<br>procedures for the detection and<br>semi-quantitation of human<br>autoantibodies to nuclear antigens<br>(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 |
| Differences | | |
| Stability<br>(Opened) | Once opened the analytes will be<br>stable for 60 days. | No claim for stability |
| Packaging | 1 vial of each single analyte<br>control | Single analyte control |
| Analyte | ANA Homogeneous Pattern<br>ANA Centromere Pattern<br>ANA Speckled Pattern<br>ANA Nucleolar Pattern | ANA Homogeneous Pattern |

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Table 2. Similarities and Differences between new and predicate device

Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns and Liquichek™ ANA Control, Centromere Pattern

| Characteristics | Liquichek™ ANA Controls Set,<br>Positive: Homogeneous,<br>Speckled, Centromere, and<br>Nucleolar Patterns<br>(New Device) | Liquichek™ ANA Control,<br>Centromere Pattern<br>(Predicate Device) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The Liquichek ANA Controls Set,<br>Positive: Homogeneous,<br>Speckled, Centromere, and<br>Nucleolar Patterns, is intended for<br>use as an unassayed quality<br>control set to 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 |
| Differences | | |
| Stability<br>(Opened) | Once opened the analytes will be<br>stable for 60 days. | Once opened the analyte will be<br>stable for 30 days. |
| Packaging | 1 vial of each single analyte<br>control | Single analyte control |
| Analyte | ANA Homogeneous Pattern<br>ANA Centromere Pattern<br>ANA Speckled Pattern<br>ANA Nucleolar Pattern | ANA Centromere Pattern |

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Table 3. Similarities and Differences between new and predicate device

Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns and Kallestad™ Autoantibody Positive Control

| Characteristics | Liquichek™ ANA Controls Set,<br>Positive: Homogeneous,<br>Speckled, Centromere, and<br>Nucleolar Patterns<br>(New Device) | Kallestad™ Autoantibody Positive<br>Control<br>(Predicate Device) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The Liquichek ANA Controls Set,<br>Positive: Homogeneous,<br>Speckled, Centromere, and<br>Nucleolar Patterns, is intended for<br>use as an unassayed quality<br>control set to monitor indirect<br>immunofluorescent testing of<br>antinuclear antibodies (ANA). | The Autoantibody Positive Control<br>is a replacement reagent in the<br>Kallestad Fluorescent<br>Autoantibody test with mouse<br>kidney, mouse stomach/kidney,<br>Hep-2 cell line, or Crithidia luciliae<br>substrates. |
| 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 |
| Differences | | |
| Stability<br>(Opened) | Once opened the analytes will be<br>stable for 60 days. | No claim for stability |
| Packaging | 1 vial of each single analyte<br>control | Single analyte control |
| Analyte | ANA Homogeneous Pattern<br>ANA Centromere Pattern<br>ANA Speckled Pattern<br>ANA Nucleolar Pattern | ANA: Centromere Pattern, SSA,<br>SSB, Scl-70, Sm, RNP, Spindle<br>Pattern, Nucleolar Pattern<br>AMA<br>ASMA<br>APCA<br>Anti-nDNA |

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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 Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns. Product claims are as follows:

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

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/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird in flight, with three curved lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.

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

k024230 Re:

> Trade/Device Name: Liguichek110 ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns 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 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):____________________________________________________________________________________________________________________________________________________

Device Name: Liquichek ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns

Indications for Use:

The Liquichek ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns, is intended for use as an unassayed quality control set 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 or

Over-the Counter use

AP Reeves for J. Bautista

Clinical Labora