(6 days)
Not Found
No
The 510(k) summary describes a quality control material for an enzyme immunoassay, which is a standard laboratory test. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description focuses on the composition and form of the control material.
No.
Explanation: The device is an unassayed quality control for monitoring enzyme immunoassay procedures for detecting SS-A autoantibodies, not a device used for therapy.
No
Explanation: The device is described as an "unassayed quality control" to monitor enzyme immunoassay procedures, not a device used to diagnose a patient's condition directly.
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 clearly states it's for "monitoring enzyme immunoassay procedures for the detection of SS-A autoantibodies." This indicates it's used in a laboratory setting to evaluate the performance of a diagnostic test.
- Device Description: It's prepared from human serum and used in liquid form, consistent with materials used in in vitro diagnostic testing.
- Predicate Device: The mention of a predicate device (K954723 Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit) further confirms its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory purposes in the IVD space.
The information provided aligns with the definition of an in vitro diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
N/A
Intended Use / Indications for Use
Liquichek Anti-SS-A Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of SS-A autoantibodies.
Product codes (comma separated list FDA assigned to the subject device)
LKJ
Device Description
Liquichek Anti-SS-A 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.
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 2 398
Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits and letters. The sequence appears to be 'K984470'. The characters are written in a bold, somewhat rough style, giving them a distinct and easily readable appearance. The contrast between the characters and the background is high, making the sequence stand out.
Image /page/0/Picture/2 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 Diagnostics Group 9500 Jeronimo Road vine, California 92618-2017 elephone: (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-SS-A Control, EIA
Classification Name Class II, 82LKJ CFR 866.5100: Antinuclear Antibody, Antigen, 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-SS-A Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of SS-A autoantibodies.
1
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 bold, sans-serif font.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek Anti-SS-A 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 Liguichek Anti-SS-A, EIA and the device to which substantial equivalence is claimed.
| | Helix Enzyme Immunoassay Antinuclear
Antibody Screening Test Kit | Bio-Rad Liquichek Anti-SS-A
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 SS-A
autoantibodies. |
| orm | 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-SS-A |
| Open Vial
Claim | Shelf life | 30 Days at 2-8°C |
2
Image /page/2/Picture/2 description: The image shows a partial view of a logo or emblem, likely from a government department. The visible portion includes a stylized graphic element consisting of three curved, parallel lines that resemble a simplified representation of waves or a flowing object. To the left of the graphic, part of the text "DEPARTMENT OF" is visible, suggesting the complete logo includes the full name of the department.
DEC 2 2 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
K984470 Re: Trade Name: Liquichek ANA-SS-A Control, EIA Model #209 Regulatory Class: II Product Code: LKJ 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 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 Requlation (QS) for Medical Devices: General requlation (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.
3
Paqe 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 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 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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Page 1 of 1
Rage 20 510(k) Number: Device Name: Liquichek Anti-SS-A Control, EIA
Indications for Use:
Liquichek Anti-SS-A Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Anti-SS-A 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 | K984470 |
|---|---|
| 510(k) Number |
| Prescription Use | |
|---|---|
| ------------------ | ------------- |
OR Over-The Counter Use