(6 days)
Liquichek Anti-Sm Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Smith (Sm) autoantibodies.
Liquichek Anti-Sm 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 text is a 510(k) Summary for the Bio-Rad Liquichek Anti-Sm Control, EIA. This document is a premarket notification for an in vitro diagnostic device and focuses on establishing substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific acceptance criteria in terms of analytical performance.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in this type of regulatory submission. The document explicitly states its purpose is to claim substantial equivalence, which is a different regulatory pathway than demonstrating performance against established acceptance criteria through a comprehensive clinical or analytical study.
Here's a breakdown of what can be extracted and what is not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided 510(k) Summary. The document focuses on comparing the technological characteristics of the new device to a predicate device, not on presenting performance data against defined acceptance criteria for the new device itself.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available. The document describes the device and claims substantial equivalence, but it does not detail any performance studies that would involve a "test set" in the context of analytical or clinical performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not available. As no performance study with a test set is described, there's no mention of experts or ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not available.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This information is not available. The device described is an "unassayed quality control" for an enzyme immunoassay. It is a control material, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not available. The device is a quality control material, not an algorithm.
7. The Type of Ground Truth Used:
This information is not available.
8. The Sample Size for the Training Set:
This information is not available. The document does not describe the development of an algorithm or model that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not available.
Summary of Available Information from the Provided Text:
- Device Name: Liquichek Anti-Sm Control, EIA
- Intended Use: "An unassayed quality control serum for monitoring enzyme immunoassay procedures for the detection of Smith (Sm) autoantibodies."
- Device Description: Prepared from human serum with added preservatives and stabilizers, in liquid form. Contains 0.1% sodium azide as a preservative.
- Predicate Device: Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit (K954723)
- Comparison to Predicate: A table is provided contrasting the intended use, form, matrix, levels, storage, and analytes of the new device and the predicate device. Key differences highlighted:
- Intended Use: Predicate is a diagnostic screening test for various ANAs; New device is an unassayed QC for Anti-Sm autoantibodies.
- Levels: Predicate has Negative, Positive, Cutoff; New device has Negative, Positive, High Positive.
- Analytes: Predicate detects many ANAs; New device specifically targets Anti-Sm.
- Open Vial Claim: Predicate states "Shelf life"; New device claims "30 Days at 2-8°C".
- Regulatory Outcome: Substantial Equivalence (K984479) was granted by the FDA on December 22, 1998, under Class II, Product Code LKP.
In conclusion, this document serves its purpose as a 510(k) summary for substantial equivalence but does not contain the detailed study information typically associated with proving a device meets specific performance acceptance criteria through a dedicated study.
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DEC 2 2 1998
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Bio-Rad Laboratories
alifornia 92618-201 ne: (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 Anti-Sm Control, EIA
Classification Name Class II. 82LKP CFR 866.5100: Anti-Sm 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 Anti-Sm Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Smith (Sm) 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 Anti-Sm 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-SmControl, EIA and the device to which substantial equivalence is claimed.
| Helix Enzyme Immunoassay AntinuclearAntibody Screening Test Kit | Bio-Rad Liquichek Anti-SmControl, 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 Smith (Sm)autoantibodies. |
| rm | 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-Sm |
| 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: K984479 Trade Name: Liquichek Anti-Sm Control, EIA Model #208 Requlatory Class: II Product Code: LKP 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 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 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. this response to your premarket notification Please note: 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 beqin 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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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KG8 4479 510(k) Number: Device Name: Liquichek Anti-Sm Control, EIA
Indications for Use:
Liquichek Anti-Sm Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Smith (Sm) 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 ____________
| Prescription Use | |
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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).