(6 days)
Liquichek Anti-SS-B Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of SS-B autoantibodies.
Liquichek Anti-SS-B Control, EIA 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.
The provided document, a 510(k) Summary for the Bio-Rad Liquichek Anti-SS-B Control, EIA, does not contain information about acceptance criteria or a study demonstrating device performance against such criteria.
The document focuses on:
- Device Description: Composition and intended use of the Liquichek Anti-SS-B Control, EIA.
- Substantial Equivalence: A comparison of the Bio-Rad device to a predicate device (Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit) to establish technological similarities.
- FDA Clearance: The FDA's letter granting 510(k) clearance, confirming substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria. The document does not describe performance studies, sensitivity/specificity, sample sizes used for testing, ground truth establishment, expert qualifications, or MRMC studies.
The device itself is an "unassayed quality control," meaning it's a control material for other assays, not a diagnostic test with performance metrics like sensitivity or specificity being developed or evaluated in this document. Its "performance" would likely refer to its stability, consistency, and ability to produce expected results in the assays it controls, but this is not detailed here.
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BIO-RAD
Laboratories
one: (949) 598-1200
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation ాecember 14, 1998
Device (Trade & Common Name) Liquichek Anti-SS-B 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-SS-B Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of SS-B autoantibodies.
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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. The logo is in white text on a black background. The text is bold and sans-serif. The logo is simple and recognizable.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek Anti-SS-B Control, EIA 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-SS-B, EIA and the device to which substantial equivalence is claimed.
| Helix Enzyme Immunoassay AntinuclearAntibody Screening Test Kit | Bio-Rad Liquichek Anti-SS-BControl, EIA | |
|---|---|---|
| Intended Use | A qualitative enzyme immunoassay (EIA) forscreening the presence of antinuclearantibodies (ANAs) in human serum as an aidin the diagnosis of certain systemic rheumaticdiseases. | An unassayed quality controlserum for monitoring enzymeimmunoassay procedures forthe detection of SS-Bautoantibodies. |
| 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:DNA (dsDNA, nDNA)HistonesSS-A/RoSS-B/LaSmSmRNPScl-70Jo-1Centrometric antigensSera positive for Immunofluorescent(IFA) Hep-2 ANAs | Anti-SS-B |
| Open VialClaim | Shelf life | 30 Days at 2-8°C |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background. The overall design is simple and professional, reflecting the organization's role in public health and human services.
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
K984478 Re: Trade Name: Liquichek Anti-SS-B Control, EIA Model #210 Requlatory Class: II Product Code: LKJ Dated: December 14, 1998 December 16, 1998 Received:
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 The general controls provisions of the provisions of the Act. Act include requirements for annual registration, listing of devices, qood 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 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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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) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/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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K984479 510(k) Number: Device Name: Liquichek Anti-SS-B Control, EIA
Indications for Use:
Liquichek Anti-SS-B Control, ElA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Anti-SS-B autoantibodies.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: /984478
| Prescription Use | OR | Over-The Counter Use | ||
|---|---|---|---|---|
| ------------------ | ---------------------------------------------- | ---- | ---------------------- | -- |
§ 866.5100 Antinuclear antibody immunological test system.
(a)
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).(b)
Classification. Class II (performance standards).