(52 days)
K 855221/A
Not Found
No
The device description and performance studies focus on standard ELISA methodology and statistical analysis of results, with no mention of AI or ML.
No
This device is an in vitro diagnostic (IVD) ELISA kit designed for the detection and measurement of a biomarker to aid in diagnosis, not to provide therapy.
Yes
The device is described as an aid in the diagnosis and management of rheumatic diseases, and it detects and measures IgM rheumatoid factor, which is used to establish the presence of rheumatoid factor.
No
The device description clearly outlines a laboratory-based immunoassay kit involving physical reagents, microwell plates, and an EIA Plate reader, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of circulating IgM rheumatoid factor." It also mentions its use "in establishing the presence of rheumatoid factor and as an aid in the diagnosis and management of rheumatic diseases." This clearly indicates it's used to test samples taken from the human body to provide information for diagnostic purposes.
- Device Description: The description details how the assay works using "human serum and plasma," which are biological specimens taken from the body.
- Performance Studies: The performance studies describe testing with "serum specimens from rheumatoid arthritis patients and normal apparently healthy donors," further confirming its use with human samples.
These points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of circulating IgM rheumatoid factor. When used according to instructions, the kit is useful in establishing the presence of rheumatoid factor and as an aid in the diagnosis and management of rheumatic diseases.
Product codes
System, Test, Rheumatoid Factor
Device Description
An enzvme-linked immunosorbent assay (ELISA) designed for the detection and measurement of IgM rheumatoid factor in human serum and plasma.
The ELISA methodology is commonly used for antibody evaluations. Purified IgG has been attached to the inner surfaces of the microwell plate. During the initial incubation step, rheumatoid factor in patient serum or plasma binds specifically to the immobilized IgG and remains in place after a wash step.
A second antibody which is conjugated to horseradish peroxidase (HRP) is used to recognize the "u" chain regions of the patient's IgM rheumatoid factor remaining after the wash step. In the wells where the second antibody remains bound. the coniugated HRP catalyzes a color change in the substrate. After the reaction is stopped, the color is read in an EIA Plate reader.
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
Not Found
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
- Precision:
- Inter-assay reproducibility (Between-run): Eight different serum samples were assayed five times each, twice a day, on five different days (a total of 50 readings). Results were presented as Mean IU/mL, Std. Dev., % CV, Mean O.D., Std. Dev., and % CV.
- Intra-assay reproducibility (Within-run): Eight different samples were assayed 10 consecutive times in a single run. Results were presented as Mean IU/mL, Std. Dev., % CV, Mean O.D., Std. Dev., and % CV.
- Verification of the RF Calibrators: A study was conducted to demonstrate the high degree of correlation between the kit calibrators and the World Health Organization International Reference Preparation of Rheumatoid Arthritis Serum.
- Comparison Testing: The Hemagen Rheumatoid Factor Kit and the Hemagen RF Hemagglutination Kit were used to assay serum specimens from rheumatoid arthritis patients and normal apparently healthy donors.
- Table 1: RF panels, N = 106. Proposed Device vs. Predicate Device.
- Table 2: Normal blood donors, N = 82. Proposed Device vs. Predicate Device.
- Assay performance with Serum and Plasma: Ninety two (92) matched serum and plasma samples were compared. Half of the volume of each sample was converted to serum by recalcification using a standard Ca 2*/thrombin methodology. All samples were evaluated with the Hemagen Rheumatoid Factor Kit.
- Interfering Substances: Lipemic, hemolytic, and icteric samples were evaluated.
- Prozone: The Hemagen Rheumatoid Factor Kit was used to assay a high-titered serum sample to determine if the kit would return unexpectedly low values.
Key Metrics
- Relative analytical sensitivity: (73/77), 94.8 % {87.3 % to 97.9%} 0.95 exact confidence interval
- Relative analytical specificity: (27/29), 93.1 % (78.0 % to 98.1 %) 0.9 axed confience internal
- Interfering substances: No significant effect (
§ 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).
0
SEP 12 1986
PAGE l
长962836 510(k) Summary
Submitter's Name/Contact Person 1.
Joseph M. Califano, Manager, Regulatory Affairs
Address
Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, MA, 02154
(617) 890-3766 Phone: Fax: (617) 890-3748
Date Prepared: 19 July 1996
2. Device Name
ﻤﺴﺘﻌﻤ
| Trade Name: | Hemagen® Rheumatoid Factor Kit |
|---|---|
| Common Name: | RF (Rheumatoid Factor) |
| Classification Name: | System, Test, Rheumatoid Factor |
3. Predicate Device
Hemagen ® RF Kit {Reference 510 (k) No. K 855221/A}
1
3. Description of Device
An enzvme-linked immunosorbent assay (ELISA) designed for the detection and measurement of IgM rheumatoid factor in human serum and plasma.
The ELISA methodology is commonly used for antibody evaluations. Purified IgG has been attached to the inner surfaces of the microwell plate. During the initial incubation step, rheumatoid factor in patient serum or plasma binds specifically to the immobilized IgG and remains in place after a wash step.
A second antibody which is conjugated to horseradish peroxidase (HRP) is used to recognize the "u" chain regions of the patient's IgM rheumatoid factor remaining after the wash step. In the wells where the second antibody remains bound. the coniugated HRP catalyzes a color change in the substrate. After the reaction is stopped, the color is read in an EIA Plate reader.
4. Intended Use of Device
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of circulating IgM rheumatoid factor. When used according to instructions, the kit is useful in establishing the presence of rheumatoid factor and as an aid in the diagnosis and management of rheumatic diseases.
Technological Characteristics 5.(A)
Proposed Device
The Hemagen Rheumatoid Factor Kit is an enzyme-linked immunosorbent assay. The device utilizes optical density as a measure of antibody presence, with an established cutoff point and equivocal zone, between a positive and a negative reaction.
Predicate Device
The Hemagen RF(HA) Kit is a hemagglutination based assay. The device utilizes the method of agglutination of specifically sensitized human erythrocytes by patient serum containing rheumatoid factor. The resultant level of agglutination is used to determine the presence or absence of rheumatoid factor.
2
5.(B) Performance Data
1. Precision
To evaluate precision, inter-assay and intra-assay studies were conducted.
Inter-assay reproducibility {Between-run} A.
Eight different serum samples were assayed five times each, twice a day, on five different days (a total of 50 readings)
| Sample | Mean IU/mL | Std. Dev. | % CV | Mean O.D. | Std. Dev. | % CV |
|---|---|---|---|---|---|---|
| 1 |