LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130

K024220 · Bio-Rad · DHN · Jan 17, 2003 · Immunology

Device Facts

• Record ID: K024220
• Device Name: LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
• Applicant: Bio-Rad
• Product Code: DHN · Immunology
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The Liquichek™ Autoimmune Negative Control is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the analytes listed in this package insert.

Device Story

Liquichek™ Autoimmune Negative Control is a liquid, human serum-based quality control material used in clinical laboratories to monitor the performance of indirect immunofluorescent (IFA) assays. It serves as a negative control for detecting antinuclear antibodies (ANA) with various patterns (speckled, centromere, homogenous, mitotic spindle). The device is intended for professional use by laboratory personnel to ensure the accuracy and reliability of autoimmune testing procedures. By providing a stable, known negative sample, it allows clinicians to verify that the IFA test system is functioning correctly, thereby reducing the risk of false-positive results in patient diagnostics.

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

Liquid human serum-based control with added preservatives. Storage at 2°C to 8°C. Designed for use in indirect immunofluorescent (IFA) testing systems.

Indications for Use

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

• Kallestad™ Autoantibody Negative Control (K780899A)

Submission Summary (Full Text)

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Bio-Rad Laboratories

Premarket Notification Section 510(k) for Liquichek™ Autoimmune Negative Control.

Summary of Safety and Effectiveness

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## Summary of Safety and Effectiveness Liquichek™ Autoimmune Negative Control

### 1.0 Submitter

JAN 1 7 2003

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

## Contact Person

Yvette Lloyd Senior Requlatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

December 20, 2002

#### 2.0 Device Identification

| Product Trade Name: | Liquichek™ Autoimmune Negative Control |
|---------------------|----------------------------------------|
|---------------------|----------------------------------------|

Antinuclear Antibody, Indirect Immunofluorescent, Common Name: Antigen, Control

| Classifications: | Class II |
|--------------------|-----------------|
| Product Code: | 82DHN |
| Regulation Number: | 21 CFR 866.5100 |

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

Kallestad ™ Autoantibody Negative Control Bio-Rad Laboratories

510 (k) Number: K780899A

### Description of Device 4.0

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™ Autoimmune Negative Control is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the analytes listed in this package insert.

### 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:

Kallestad™ Autoantibody Negative Control Bio-Rad Laboratories

510 (k) Number: K780899A

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

| Characteristics | Liquichek™ Autoimmune<br>Negative Control | Kallestad™ Autoantibody Negative<br>Control |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (New Device) | (Predicate Device) |
| Similarities | | |
| Intended Use | The Liquichek™ Autoimmune<br>Negative Control is intended for<br>use as an unassayed quality<br>control to monitor indirect<br>immunofluorescent testing for the<br>analytes listed in this package<br>insert. | The Autoantibody Negative 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. This test is an indirect<br>fluorescent antibody (IFA)<br>procedure for the detection and<br>semi-quantitation of human<br>antibodies. |
| 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 analyte will be<br>stable for 60 days. | No open vial claims |
| Analyte | Antinuclear antibodies (ANA)<br>Speckled Pattern, Antinuclear<br>antibodies (ANA) Centromere<br>Pattern, Antinuclear antibodies<br>(ANA) Homogenous Pattern,<br>Antinuclear antibodies (ANA)<br>Mitotic Spindle Pattern. | No claims |

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## 7.0 STATEMENT OF SUPPORTING DATA

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Autoimmune Negative Control. Product claims are as follows:

- 7.1 Once the control is opened the analyte 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 - 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other, forming a symbolic representation of health and human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

JAN 1 7 2003

Re: k024220

Trade/Device Name: Liquichek™ Autoimmune Negative Control Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory 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 (OS) 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):_ КОДЧАДО

Device Name: Liquichek™ Autoimmune Negative Control

Indications for Use:

The Liquichek™ Autoimmune Negative Control is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the analytes listed in this package insert

(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

Aflues for L. Bautista

(Division Sign-Off) Division of Clinical Laborat 510(k) Number -