(85 days)
Liquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's rheumatoid factor testing methodologies.
Liquichek Rheumatoid Factor Control is prepared from human serum with added constituents of human origin.
This is a 510(k) summary for a medical device called "Liquichek Rheumatoid Factor Control" and concerns a quality control serum, not an AI/ML powered device. As such, the information requested in your prompt (acceptance criteria, study details like sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission for a quality control product.
The document discusses the intended use, device description, and a comparison of technological characteristics to a previously cleared device for establishing substantial equivalence. It does not contain any performance data against acceptance criteria in the way you've described for an AI/ML diagnostic or prognostic device.
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Image /page/0/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 and is slightly rounded.
Bio-Rad
Laboratories
ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
Telephone (714) 630-6400
Toll Free (800) 854-6737
510(k) Summary
K96098-7
JUN - 4 1996
Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 (714)630-6400 Fax (714)666-1383
Contact Persons Elizabeth Platt
Date of Summary Preparation May 2, 1996
Device (Trade & Common Name) Liquichek Rheumatoid Factor Control
Classification Name Class II CFR 866.5775. Rheumatoid Factor Immunological Test System 82DHR
Devices to Which Substantial Equivalence is Claimed Liquichek Rheumatoid Factor Control K923578
Statement of Intended Use
Liquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's rheumatoid factor testing methodologies.
Description of the Device
Liquichek Rheumatoid Factor Control is prepared from human serum with added constituents of human origin.
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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 rounded rectangle. The text is in a bold, sans-serif font.
aboratories
ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
Statement of How Technological Characteristics Compare to Substantial Equilavence Device
A table is provided below comparing the technological characteristics between Liquichek Rheumatoid Factor Control and the original device to which substantial equivalence is claimed.
| Liquichek RheumatoidFactor Control(original submission) | Liquichek RheumatoidFactor Control(additional information submitted in 1996) | |
|---|---|---|
| IntendedUse | assayed control forrheumatoid factor testingmethodologies | assayed control forrheumatoid factortesting methodologies |
| Matrix | Human Serum | Human Serum |
| ProductLevels | single level product | trilevel level product(two additional levelsadded) |
| Storage | 2-8°C | 2-8°C |
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).