ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM

• K Number: K033802
• Device Name: ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
• Manufacturer: ZEUS SCIENTIFIC, INC.
• Date Cleared: 2004-02-27 ( 81 days)
• Product Code: DHR
• Regulation Number: 866.5775
• Type: Traditional
• Panel: IM
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System is intended for the qualitative and quantitative detection of RF IgM class antibody in human serum. The test system is intended for the analysis of human serum for the presence of IgM RF. The test system is intended to be used as aid in the diagnosis of rheumatoid arthritis. The test is for in vitro diagnostic use.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for the AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System and focuses on regulatory approval rather than detailed study design or acceptance criteria.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Information on MRMC comparative effectiveness studies.
6. Details on standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Regulation Number and Section

§ 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).