(6 days)
Liquichek ANA Control, EIA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of antinuclear antibodies (ANA).
Liquichek ANA Control, EIA Screen 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 text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a quality control device (Liquichek ANA Control, EIA Screen) and focuses on demonstrating substantial equivalence to a predicate device.
Specifically, the document includes:
- Intended Use: The device is for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of antinuclear antibodies (ANA).
- Comparison to Predicate Device: A table comparing the technical characteristics of the Bio-Rad Liquichek ANA Control, EIA Screen to the Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit. This comparison highlights similarities in form, matrix, storage, and general purpose.
- FDA Clearance Letter: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
However, it lacks the following information that would be necessary to answer the prompt:
- Acceptance Criteria and Reported Device Performance: No specific numerical or qualitative acceptance criteria are defined for the performance of the Bio-Rad device itself, nor are there any study results that report its performance against such criteria.
- Study Details: There is no description of any study (e.g., sample size, data provenance, ground truth establishment, expert involvement, adjudication methods, MRMC studies, or standalone performance studies). This is expected for a quality control device seeking 510(k) clearance, as the primary focus is often on demonstrating equivalence to an existing product rather than de novo performance validation against clinical endpoints.
- Training Set Information: Since no performance study is described, there is no information about training sets or how their ground truth would have been established.
In summary, based on the provided text, it is not possible to describe the acceptance criteria or a study that proves the device meets those criteria.
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DEC 22 1998
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Laboratories
alifornia 92618-2017 ephone: (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 December 14, 1998
Device (Trade & Common Name) Liquichek ANA Control, EIA Screen
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 ANA Control, EIA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of antinuclear antibodies (ANA).
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Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek ANA Control, EIA Screen 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. EIA Screen and the device to which substantial equivalence is claimed.
| Helix Enzyme Immunoassay AntinuclearAntibody Screening Test Kit | Bio-Rad Liquichek ANA Control,EIA Screen | |
|---|---|---|
| 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 screening of antinuclearantibodies (ANA). |
| 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 | Antinuclear antibodies (ANA). |
| Open VialClaim | Shelf life | 30 Days at 2-8°C |
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 22 1998
Ms. Elizabeth Platt Staff Requlatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K984473 Trade Name: Liquichek ANA Control, EIA Screen Model #205 Requlatory 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 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.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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K984473 510(k) Number: Device Name: Liquichek ANA Control, EIA Screen
Indications for Use:
Liquichek ANA Control, EIA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of antinuclear antibodies (ANA).
(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 | K984473 |
| 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).