(6 days)
Liquichek ENA Control, EIA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of extractable nuclear antigen (ENA) autoantibodies.
Liquichek ENA 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 document is a 510(k) summary for the Bio-Rad Liquichek ENA Control, EIA Screen, a quality control device. It does not contain information about acceptance criteria or a study proving the device meets performance criteria in the way a diagnostic device would. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested fields cannot be filled as they are not applicable to this type of submission.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. The document focuses on comparing the technological characteristics of the Bio-Rad Liquichek ENA Control, EIA Screen to its predicate device, the Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit, to establish substantial equivalence as a quality control. It does not present specific performance criteria or results of a study to demonstrate the performance of the Bio-Rad device itself against such criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a study involving a test set of patient samples for performance evaluation. The "test set" in the context of a quality control device would typically refer to the stability or value assignment studies, but this information is not detailed here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth establishment with experts is usually associated with diagnostic devices, where expert consensus or pathological findings are used to define the true positive/negative status of a sample. For a quality control material, the ground truth relates to its assigned values and stability, which are determined through manufacturing and validation processes, not expert review of patient cases.
4. Adjudication method for the Test Set
Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often assisted by AI, to assess the impact of the AI on reader performance. The Liquichek ENA Control, EIA Screen is a quality control material, not a diagnostic device that humans interpret in a clinical setting.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a quality control material, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for a quality control material like the Liquichek ENA Control, EIA Screen would be its assigned values (Negative, Positive, High Positive) for monitoring enzyme immunoassay procedures. These values are established through rigorous manufacturing and validation processes by the manufacturer, rather than expert consensus, pathology, or outcomes data related to patient diagnosis.
8. The Sample Size for the Training Set
Not applicable. The device is a quality control material, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
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DEC 22 1998
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Laboratories
ornia 92618-2 hone: (949) 598-12
984462
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
Jevice (Trade & Common Name) Liquichek ENA Control, EIA Screen
Classification Name Class II, 82LLL CFR 866.5100: Extractable Antinuclear Antibody, Antigen and 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 ENA Control, ElA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of extractable nuclear antigen (ENA) autoantibodies.
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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 ENA 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 ENA Control, EIA Screen and the device to which substantial equivalence is claimed.
| Helix Enzyme Immunoassay AntinuclearAntibody Screening Test Kit | Bio-Rad Liquichek ENAControl,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 extractablenuclear antigen (ENA)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:DNA (dsDNA, nDNA)HistonesSS-A/RoSS-B/LaSmSmRNPScl-70Jo-1Centrometric antigensSera positive for Immunofluorescent(IFA) Hep-2 ANAs | ENA |
| 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 Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K984462 Trade Name: Liquichek ENA Control, EIA Screen Regulatory Class: II Product Code: LLL Dated: December 14, 1998 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 aqainst 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 Requlations, 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.gov/cdrh/dsma/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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Page 1 of 1
198440 510(k) Number: Device Name: Liquichek ENA Control, EIA Screen
Indications for Use:
Liquichek ENA Control, EIA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of extractable nuclear antigen (ENA) 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 | K984462 |
|---|---|
| --------------- | --------- |
| 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).