LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204

K984399 · Bio-Rad · DHN · Dec 18, 1998 · Immunology

Device Facts

• Record ID: K984399
• Device Name: LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
• Applicant: Bio-Rad
• Product Code: DHN · Immunology
• Decision Date: Dec 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

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

Device Story

Liquichek ANA Control, Nucleolar Pattern is an unassayed quality control serum; prepared from human serum with added preservatives (0.1% sodium azide) and stabilizers. Provided in liquid form; used by laboratory personnel to monitor the performance of indirect immunofluorescent (IIF) assays for antinuclear antibodies (ANA). The control provides negative, positive, and high positive levels to verify assay accuracy and precision. By comparing observed results against expected patterns, clinicians ensure the reliability of patient test results; facilitating accurate diagnosis and monitoring of autoimmune conditions associated with ANA.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Human serum matrix; liquid form; contains 0.1% sodium azide preservative; stored at 2-8°C; shelf life includes 30-day open-vial stability at 2-8°C. Analyte: ANA (Nucleolar Pattern).

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

• Kallestad Quantafluor Autoantibody Positive Control (K813592)

Submission Summary (Full Text)

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K984399

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Bio-Rad Laboratories

Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: [phone]

#### Description of the Device

Liquichek ANA Control, Nucleolar Pattern is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

## Statement of How Technological Characteristics Compare to Substantial Equivalent Device

A table is provided below comparing the similarities between the Bio-Rad Liquichek ANA Control, Nucleolar Pattern and the device to which substantial equivalence is claimed.

| | Kallestad Quantafluor Autoantibody Positive<br>Control | Bio-Rad Liquichek<br>ANA Control, Nucleolar Pattern |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Autoantibody positive control for Kallestad<br>Quantafluor Fluorescent Autoantobody Test<br>with mouse kidney, mouse stomach/kidney,<br>Hep-2 cell line, or Crithidia luciliae substrates. | An unassayed quality control<br>serum for monitoring indirect<br>immunofluorescent testing of<br>antinuclear antibodies (ANA). |
| Form | Lyophilized | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Positive | Negative, Positive, High<br>Positive |
| Storage | 2-8°C | 2-8°C |
| Analytes | ANA (Centromere, SSA, SSB, Scl-70, Sm,<br>RNP, Spindle, Nucleolar)<br>AMA<br>ASMA<br>APCA<br>Anti-nDNA | ANA (Nucleolar Pattern) |
| Open Vial<br>Claim | 6 weeks at 2-8°C<br>4 months at -20°C | 30 Days at 2-8°C |

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

# 510(k) Summary

Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation December 8, 1998

# Device (Trade & Common Name) Liquichek ANA Control, Nucleolar Pattern

Classification Name Class II, 82DHN CFR 866.5100: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control.

Devices to Which Substantial Equivalence is Claimed Kallestad Quantafluor Autoantibody Positive Control Sanofi Diagnostics Pasteur Chaska, Minnesota K813592

### Statement of Intended Use

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

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DEC 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618

Re: K984399

Trade Name: Liquichek ANA Control, Nucleolar Pattern, Model 204 Regulatory Class: II Product Code: DHN Dated: December 8, 1998 Received: December 9, 1998

Dear Ms. Platt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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R 964 399 510(k) Number: Device Name: Liquichek ANA Control, Nucleolar Pattern

Indications for Use:

Liquichek ANA Control, Nucleolar Pattern 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-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Concurrence of CDRH, Office of Device Evaluation)

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| (Division Sign-Off) | |
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| Division of Clinical Laboratory Devices | |
| 510(k) Number | K984399 |

| Prescription Use | <div> <img alt="Prescription Check" src="prescription_check.png"/> </div> | OR Over-The Counter Use | |
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