(9 days)
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No
The device description and intended use are for a quality control material for laboratory testing, not a diagnostic or analytical device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is a quality control material intended to monitor testing for antinuclear antibodies, not to treat a condition.
No
This device is described as an "unassayed quality control" used to "monitor indirect immunofluorescent testing of antinuclear antibodies (ANA)." It is designed to check the performance of a diagnostic test, not to perform a diagnosis itself.
No
The device description clearly states it is a liquid control material prepared from human serum, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring indirect immunofluorescent testing of antinuclear antibodies (ANA)". This testing is performed in vitro (outside the body) on patient samples (presumably serum, as the control is prepared from human serum).
- Device Description: The description confirms it's a "quality control" prepared from "human serum". Quality controls are used to ensure the accuracy and reliability of in vitro diagnostic tests.
The definition of an IVD is a medical device that is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that definition as it's used to monitor the performance of a diagnostic test (ANA testing) performed on human specimens.
N/A
Intended Use / Indications for Use
Liquichek ANA Control, Nucleolar Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
Product codes
DHN
Device Description
Liquichek ANA Control, Nucleolar Pattern 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image shows the words "DEC 18 1998" at the top. Below that is the logo for BIO-RAD. The logo is in a black rounded rectangle with the words BIO-RAD in white.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek ANA Control, Nucleolar Pattern 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, Nucleolar Pattern and the device to which substantial equivalence is claimed.
| | Kallestad Quantafluor Autoantibody Positive
Control | Bio-Rad Liquichek
ANA Control, Nucleolar Pattern |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Autoantibody positive control for Kallestad
Quantafluor Fluorescent Autoantobody Test
with mouse kidney, mouse stomach/kidney,
Hep-2 cell line, or Crithidia luciliae substrates. | An unassayed quality control
serum for monitoring indirect
immunofluorescent testing of
antinuclear antibodies (ANA). |
| Form | Lyophilized | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Positive | Negative, Positive, High
Positive |
| Storage | 2-8°C | 2-8°C |
| Analytes | ANA (Centromere, SSA, SSB, Scl-70, Sm,
RNP, Spindle, Nucleolar)
AMA
ASMA
APCA
Anti-nDNA | ANA (Nucleolar Pattern) |
| Open Vial
Claim | 6 weeks at 2-8°C
4 months at -20°C | 30 Days at 2-8°C |
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Image /page/1/Picture/0 description: The image shows the logo for BIO-RAD. The logo is white text on a black background. The text is in a sans-serif font and is slightly stylized. The logo is simple and easy to read.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (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 8, 1998
Device (Trade & Common Name) Liquichek ANA Control, Nucleolar Pattern
Classification Name Class II, 82DHN CFR 866.5100: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control.
Devices to Which Substantial Equivalence is Claimed Kallestad Quantafluor Autoantibody Positive Control Sanofi Diagnostics Pasteur Chaska, Minnesota K813592
Statement of Intended Use
Liquichek ANA Control, Nucleolar Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
DEC 1 8 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618
Re: K984399
Trade Name: Liquichek ANA Control, Nucleolar Pattern, Model 204 Regulatory Class: II Product Code: DHN Dated: December 8, 1998 Received: December 9, 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 Ouality System Regulation (OS) 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
4
R 964 399 510(k) Number: Device Name: Liquichek ANA Control, Nucleolar Pattern
Indications for Use:
Liquichek ANA Control, Nucleolar Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing 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 | K984399 |
| Prescription Use | OR Over-The Counter Use | ||
|---|---|---|---|
| ------------------ | --------------------------------------------------------------------------- | ------------------------- | -- |