(85 days)
No
The summary describes a quality control serum for laboratory testing, with no mention of AI or ML capabilities.
No
The device is described as an assayed quality control serum for monitoring the precision of rheumatoid factor testing, not for treating a condition.
No
Explanation: The device is a quality control serum used to monitor the precision of laboratory testing methodologies for rheumatoid factor, not to diagnose a patient's condition.
No
The device description explicitly states it is prepared from human serum with added constituents of human origin, indicating it is a physical control material, 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 the precision of an individual laboratory's rheumatoid factor testing methodologies." This means it's used in vitro (outside the body) to evaluate the performance of tests that diagnose or monitor a medical condition (rheumatoid factor).
- Device Description: It's a "quality control serum," which is a common type of IVD used to ensure the accuracy and reliability of diagnostic tests.
- Predicate Device: The mention of a predicate device (Liquichek Rheumatoid Factor Control K923578) further confirms its classification as a medical device, and specifically an IVD, as predicate devices are used for comparison in regulatory submissions for new medical devices, including IVDs.
N/A
Intended Use / Indications for 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.
Product codes
82DHR
Device Description
Liquichek Rheumatoid Factor Control is prepared from human serum with added constituents of human origin.
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
Not Found
§ 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).
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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.
1
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 Rheumatoid
Factor Control
(original submission) | Liquichek Rheumatoid
Factor Control
(additional information submitted in 1996) |
|-------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Intended
Use | assayed control for
rheumatoid factor testing
methodologies | assayed control for
rheumatoid factor
testing methodologies |
| Matrix | Human Serum | Human Serum |
| Product
Levels | single level product | trilevel level product
(two additional levels
added) |
| Storage | 2-8°C | 2-8°C |