(9 days)
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No
The summary describes a quality control material for laboratory testing, not a device that processes data or images using AI/ML.
No
This device is an unassayed quality control material used to monitor indirect immunofluorescent testing for antinuclear antibodies, not to treat a condition or disease.
No
Explanation: The device is described as an unassayed quality control for monitoring indirect immunofluorescent testing of antinuclear antibodies. It is used to monitor the testing, not to diagnose a condition directly.
No
The device description explicitly states it is prepared from human serum and provided in liquid form, 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 clearly 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 essential components of in vitro diagnostic testing to ensure the accuracy and reliability of the test results.
- Predicate Device: The mention of a predicate device (K813592 Kallestad Quantafluor Autoantibody Positive Control) which is also an IVD control further supports its classification as an IVD.
Therefore, based on the intended use and description, the Liquichek ANA Control, Speckled Pattern fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Liquichek ANA Control, Speckled Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
Product codes (comma separated list FDA assigned to the subject device)
DHN
Device Description
Liquichek ANA Control, Speckled 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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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).
0
DEC 1 8 1998
Image /page/0/Picture/14 description: The image shows the logo for BIO-RAD. The logo is in black and white, with the words "BIO" and "RAD" in large, bold letters. The plus sign is between the two words. The logo is surrounded by a black border. The date DEC 16 1986 is at the top of the image.
Bio-Rad Laboratories
California 92618-2011 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, Speckled 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, Speckled Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
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.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek ANA Control, Speckled 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, Speckled Pattern and the device to which substantial equivalence is claimed.
| | Kallestad Quantafluor Autoantibody Positive
Control | Bio-Rad Liquichek
ANA Control, Speckled 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 (Speckled 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/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three overlapping profiles, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 8 1998
Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618
Re: K984400
Trade Name: Liquichek ANA Control, Speckled Pattern, Model 202 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 (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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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
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Page 1 of 1
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Liquichek ANA Control, Speckled Pattern
Indications for Use:
Liquichek ANA Control, Speckled 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 |
| Prescription Use | OR | Over-The Counter Use | ||
|---|---|---|---|---|
| ------------------ | -- | ---- | ---------------------- | -- |