LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212

K984475 · Bio-Rad · LKJ · Dec 22, 1998 · Immunology

Device Facts

• Record ID: K984475
• Device Name: LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
• Applicant: Bio-Rad
• Product Code: LKJ · Immunology
• Decision Date: Dec 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

Liquichek Anti-Scl-70 Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Scl-70 autoantibodies.

Device Story

Liquichek Anti-Scl-70 Control, EIA is an in vitro diagnostic quality control product; prepared from human serum with added preservatives (0.1% sodium azide) and stabilizers. Provided in liquid form for laboratory use. Used by clinical laboratory personnel to monitor the performance and accuracy of enzyme immunoassay (EIA) procedures specifically for the detection of Scl-70 autoantibodies. The control is processed alongside patient samples; results are compared against expected values to ensure assay reliability. Benefits include verification of test system performance, identification of potential procedural errors, and assurance of consistent diagnostic accuracy for clinicians interpreting patient results.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid human serum matrix; contains 0.1% sodium azide preservative; stored at 2-8°C; 30-day open-vial stability. No software or electronic components.

Indications for Use

Indicated for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Anti-Scl-70 autoantibodies in human serum.

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

• Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit (K954723)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The logo is in a rounded rectangle shape. The text "BIO-RAD" is in white, bold, sans-serif font and is centered in the rectangle. The background of the rectangle is black.

Bio-Rad Laboratories iannstics Groun 00 Jeronimo Road ne, California 92618-2017 lephone: [phone]

1984475

# 510(k) Summary

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

# Contact Person Elizabeth Platt

'Date of Summary Preparation Jecember 14, 1998

Device (Trade & Common Name) Liquichek Anti-Scl-70 Control, EIA

Classification Name Class II, 82LKJ CFR 866.5100: Antinuclear Antibody, Antigen, Control.

Devices to Which Substantial Equivalence is Claimed Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit Helix Diagnostics West Sacrament, California K954723

### Statement of Intended Use

Liquichek Anti-Scl-70 Control, ElA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Scl-70 autoantibodies.

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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is a black rectangle with rounded corners, and the words "BIO-RAD" are written in white, bold letters. The letters are sans-serif and are evenly spaced. The logo is simple and recognizable.

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

# Description of the Device

Liquichek Anti-Scl-70 Control, ElA 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 Anti-Scl-70, ElA and the device to which substantial equivalence is claimed.

| | Helix Enzyme Immunoassay Antinuclear<br>Antibody Screening Test Kit | Bio-Rad Liquichek Anti-Scl-70<br>Control, EIA |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A qualitative enzyme immunoassay (EIA) for<br>screening the presence of antinuclear<br>antibodies (ANAs) in human serum as an aid<br>in the diagnosis of certain systemic rheumatic<br>diseases. | An unassayed quality control<br>serum for monitoring enzyme<br>immunoassay procedures for<br>the detection of Scl-70<br>autoantibodies. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Negative, Positive, Cutoff | Negative, Positive, High Positive |
| Storage | 2-8°C | 2-8°C |
| Analytes | Total ANAs against:<br>DNA (dsDNA, nDNA)<br>Histones<br>SS-A/Ro<br>SS-B/La<br>Sm<br>SmRNP<br>Scl-70<br>Jo-1<br>Centrometric antigens<br>Sera positive for Immunofluorescent<br>(IFA) Hep-2 ANAs | Anti-Scl-70 |
| Open Vial<br>Claim | Shelf life | 30 Days at 2-8°C |

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DEC 22 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K984475 Trade Name: Liquichek Anti-Scl-70 Control, EIA Model #212 Regulatory Class: II Product Code: LKJ December 14, 1998 Dated: Received: December 16, 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 Quality System Regulation (QS) 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.

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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 (301) Additionally, for questions on the promotion and 594-4588. 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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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510(k) Number: K 984475 Device Name: Liquichek Anti-Scl-70 Control, ElA

Indications for Use:

Liquichek Anti-Scl-70 Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Anti-Scl-70 autoantibodies.

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

(Concurrence of CDRH, Office of Device Evaluation)

*Teta E Makin*

(Division Sign-Off)

| Division of Clinical Laboratory Devices | K984475 |
|-----------------------------------------|---------|
| 510(k) Number | |

| Prescription Use | <div>✓</div> | OR | Over-The Counter Use | 1 |
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