LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119

K024225 · Bio-Rad · DHN · Jan 15, 2003 · Immunology

Device Facts

• Record ID: K024225
• Device Name: LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119
• 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™ Anti-nDNA Control, Positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of nDNA autoantibodies.

Device Story

Liquichek™ Anti-nDNA Control, Positive is a liquid human serum-based quality control material; used to monitor performance of indirect immunofluorescent assays for nDNA autoantibodies. Device provides a stable, ready-to-use liquid format compared to lyophilized alternatives. Used by laboratory personnel to verify test system accuracy and precision; helps ensure reliable detection of autoantibodies in patient samples. Benefits include improved workflow convenience and consistent monitoring of diagnostic assay performance.

Clinical Evidence

Bench testing only. Stability studies confirmed 60-day open-vial stability at 2-8°C and 2-year shelf life for unopened product stored at 2-8°C.

Technological Characteristics

Human serum matrix with added preservatives. Liquid form. Storage at 2-8°C. Analyte: Anti-nDNA.

Indications for Use

Indicated for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of nDNA 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

• Kallestad™ Autoantibody Positive Control (K780899A)

Submission Summary (Full Text)

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Page 1 of 3

K.24225

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

JAN 1 5 2003

#### 1.0 Submitter

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

# Contact Person

Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: [phone]

# Date of Summary Preparation

December 20, 2002

#### 2.0 Device Identification

Liquichek™ Anti-nDNA Control, Positive Product Trade Name:

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

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

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

Kallestad TM Autoantibody Positive 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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#### 5.0 Statement of Intended Use

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

#### 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:

Kallestad™ Autoantibody Positive Control Bio-Rad Laboratories

510 (k) Number: K780899A

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

| Characteristics | Liquichek™ Anti-nDNA Control,<br>Positive<br>(New Device) | Kallestad™ Autoantibody Positive<br>Control<br>(Predicate Device) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The Liquichek™ Anti-nDNA<br>Control, Positive is intended for<br>use as an unassayed quality<br>control to monitor indirect<br>immunofluorescent testing for the<br>detection of nDNA autoantibodies. | 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 |
| Differences | | |
| Stability<br>(Opened) | Once opened the analyte will be<br>stable for 60 days. | Aliquots of the reconstituted<br>solution are stable at 2-8°C for 6<br>weeks and at -20°C for 4 months. |
| Form | Liquid | Lyophilized |
| Analyte | Anti-nDNA | 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™ Anti-nDNA Control, Positive. 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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus symbol.

JAN 1 5 2003

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

> k024225 Trade/Device Name: Liquichek™ Anti-nDNA Control, Positive Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody (Indirect)/Immunofluorescent, Antigen, Control Regulatory Class: II Product Code: DHN Dated: December 20, 2002 Received: December 23, 2002

Dear Ms. Lloyd:

Re:

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. Iisting 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.

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### Page 2

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.

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 Sutmes

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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KO24225 510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________

Liquichek™ Anti-nDNA Control, Positive Device Name:

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use

Over-the Counter use

J. Reeve for J. Batista
(Division Sign Off)

or

Division of Clinical Laboratory Devices

KOZM225 510(k) Number -