(6 days)
Not Found
No
The summary describes a quality control material for an immunoassay, with no mention of AI or ML in the intended use, device description, or any other section.
No.
This device is an unassayed quality control used to monitor enzyme immunoassay procedures, not for direct therapeutic intervention.
No
The device is described as an "unassayed quality control" to monitor enzyme immunoassay procedures. Quality control materials are used to assess the performance of diagnostic tests but are not diagnostic devices themselves.
No
The device description clearly states it is a liquid control material prepared from human serum, indicating it is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring enzyme immunoassay procedures for the detection of Smith (Sm) autoantibodies." This involves testing biological samples (presumably serum, as the device is prepared from human serum) in vitro (outside the body) to provide information about a patient's health status (presence of autoantibodies).
- Device Description: The description confirms it's a "quality control" prepared from "human serum." Quality controls are essential components of IVD testing to ensure the accuracy and reliability of the test results.
- Predicate Device: The mention of a "Predicate Device" with a K number (K954723) and the name "Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit" strongly indicates that this device is regulated as an IVD by the FDA. Predicate devices are used to demonstrate substantial equivalence for new IVDs.
Therefore, the Liquichek Anti-Sm Control, EIA fits the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LKP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit K954723
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
DEC 2 2 1998
Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The logo is white text on a black, rounded rectangle. The text is in all caps and bolded.
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.
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is in white text on a black background. The text is bold and sans-serif. The logo is enclosed in a rounded rectangle.
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 Antinuclear
Antibody Screening Test Kit | Bio-Rad Liquichek Anti-Sm
Control, EIA |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A qualitative enzyme immunoassay (EIA) for
screening the presence of antinuclear
antibodies (ANAs) in human serum as an aid
in the diagnosis of certain systemic rheumatic
diseases. | An unassayed quality control
serum for monitoring enzyme
immunoassay procedures for
the 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)
Histones
SS-A/Ro
SS-B/La
Sm
SmRNP
Scl-70
Jo-1
Centrometric antigens
Sera positive for Immunofluorescent
(IFA) Hep-2 ANAs | Anti-Sm |
| Open Vial
Claim | Shelf life | 30 Days at 2-8°C |
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human figures or profiles facing to the right, stacked on top of each other.
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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Page 2
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 | |
|---|---|
| ------------------ | ---------------------------------------- |
OR Over-The Counter Use ____________