(73 days)
K 855221/A
K 851172, K 962386
No
The device description and performance studies describe a standard turbidimetric immunoassay and its validation, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic (IVD) device used to detect and quantify rheumatoid IgM antibodies, aiding in the diagnosis and management of rheumatoid arthritis. It does not directly treat or alleviate a disease, but rather provides diagnostic information.
Yes.
The "Intended Use" section explicitly states that the assay is "useful in establishing the presence of rheumatoid factor and as an aid in the diagnosis and management of rheumatoid arthritis."
No
The device description clearly outlines a physical latex agglutination assay involving chemical reactions and optical density measurements, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "latex agglutination assay intended for the quantitative turbidimetric detection of Rheumatoid IgM antibodies in human serum and plasma." This involves testing human samples in vitro (outside the body) to provide information for diagnosis and management.
- Device Description: The description details a laboratory test that analyzes human serum and plasma samples to detect and quantify a specific analyte (Rheumatoid Factor IgM antibodies). This is a hallmark of an IVD.
- Performance Studies: The document describes studies conducted on human serum samples to evaluate the device's performance (precision, comparison to other methods). This is typical for the validation of an IVD.
- Key Metrics: The inclusion of metrics like relative analytical sensitivity and specificity, calculated from testing human samples, further confirms its nature as an IVD.
- Predicate and Reference Devices: The mention of predicate and reference devices, which are also laboratory-based diagnostic tests, reinforces that this device falls within the category of IVDs.
The core function of the device is to analyze human biological samples in vitro to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A latex agglutination assay intended for the quantitative turbidimetric detection of Rheumatoid IgM antibodies in human serum and plasma. When used according to instructions, the assay is useful in establishing the presence of rheumatoid factor and as an aid in the diagnosis and management of rheumatoid arthritis.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Raichem's Rheumatoid Factor SPIA TM latex agglutination assay is a quantitative turbidimetric assay for the detection of Rheumatoid Factor IgM antibodies in human serum and plasma.
In this assay, latex microspheres coated with human and rabbit IgG are diluted in a m the usually, clesigned to allow aggregation without rapid settling of Rheumatoid Factor complexed microparticles. As aggregates form, the suspension becomes less cloudy, resulting in less light being absorbed. The change in optical density is proportional to the amount of RF present in the suspension.
A quantitative determination of the amount of RF present in a serum/plasma sample is made by comparison to a standard curve.
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)
Precision studies were conducted to evaluate inter-assay and intra-assay reproducibility.
Inter-assay reproducibility: Six different serum samples were assayed twice a day on four different days.
Intra-assay reproducibility: Six different serum samples were assayed 20 consecutive times in a single run.
Verification of the RF Calibrator: The RF Calibrator (120 IU/mL) was compared to the World Health Organization International Reference Preparation of Rheumatoid Arthritis Serum, demonstrating a high degree of correlation.
Comparison Testing: The subject device and the predicate device were used to assay serum specimens from rheumatoid arthritis patients, patients with autoimmune diseases, and normal apparently healthy donors (n = 335 combined). A third-party EIA method was used to evaluate discrepant and equivocal samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative analytical sensitivity = 95.4 % (144/151), 0.95 INTERVAL = 90.8 % to 97.8 %
Relative analytical specificity = 100 % (184/184), 0.95 INTERVAL = 98.0 % to 100 %
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.
K 855221/A
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.
K 851172, K 962386
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
§ 866.5775 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
K970373
April 17, 1997
PAGE 1
510(k) Summary
11:52:40 18:35:40 1
Joseph M. Califano Manager, Regulatory Affairs
Address
Hemagen Diagnostics, Inc.
34-40 Bear Hill Road Waltham, MA, 02154
(617) 890-3766 Phone: (617) 890-3748 Fax:
Date Prepared
30 Jan 1997
2. Device Name
Trade Name: Common Name: Classification Name: Rheumatoid Factor SPIA TM RF (Rheumatoid Factor) System, Test, Rheumatoid Factor
3. Predicate Device
Hemagen ® RF Kit (HA method) {510 (k) Docket No. K 855221/A}
Methods 3a.
- Described in Laboratory Diagnostic Procedures in the Rheumatic . Manual: Diseases, 3d Ed. (1985) Chep. 4 Rhoumatoid Factors, Techniques of Analysis by McDuffle, F.C.
- II. Automated System: COBAS-MIRA Analyzer. {510 (k) Docket No. k 851172)
- III. Third Party Test: Hemagen ® RF Kit (EIA method) {510 {k} Docket No. K 962386}
4. Description of Device
Raichern's Rheumatoid Factor SPIA ™ latex agglutination assay is a quantitative lught lidimet assay for the detection of Rheumatoid Factor IgM antibodies in human serum and pla
510 (k) Summary Page 1
1
4. Description of Device
Raichem's Rheumatoid Factor SPIA ™ latex agglutination assay is a quantitative turbidimetric assay for the detection of Rheumatoid Factor IgM antibodies in human serum and plasma.
In this assay, latex microspheres coated with human and rabbit IgG are diluted in a m the usually, clesigned to allow aggregation without rapid settling of Rheumatoid Factor complexed microparticles. As aggregates form, the suspension becomes less cloudy, resulting in less light being absorbed. The change in optical density is proportional to the amount of RF present in the suspension.
A quantitative determination of the amount of RF present in a serum/plasma sample is made by comparison to a standard curve.
5. Intended Use of Device
A latex agglutination assay intended for the quantitative turbidimetric detection of Rheumatoid IgM antibodies in human serum and plasma. When used according to instructions, the assay is useful in establishing the presence of rheurmatoid factor and as an aid in the diagnosis and management of rheumatoid arthritis.
6.(A) Technological Characteristics
Proposed Device
Raichem's Rheumatoid Factor SPIA™ latex agglutination assay is a quantitative turbidimetric assay. The amount of RF present is proportional to the change in optical density in the suspension. The RF IgM antibody concentration is quantified by comparison to a standard curve. This assay is performed manually following clinically accepted methodologies. The assay is designed to enable users to readily adapt it for use with automated systems such as the Roche COBAS MIRA Analyzer.
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 servim containing rheumatoid factor. The resultant level of agglutination is used to determine the presence or absence of rheumatoid factor.
2
6.(B) Performance Data
Precision l.
ﻨﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
:
ﺘﻪ .. ..
To evaluate precision, inter-assay and intra-assay studies were conducted with the To evaluate proclaision more on an automated system {COBAS-MIRA}
A. Inter-assay reproducibility
Six different serum samples were assayed twice a day on four different days.
| SAMPLE | Mean IU/mL | Std. Dev | % CV | Mean Delta | Std. Dev | % CV |
|---|---|---|---|---|---|---|
| 1 | 95.4 | 5.0 | 5.3 | 0.111 | 0.007 | 6.4 |
| 2 | 80.3 | 5.3 | 6.6 | 0.097 | 0.007 | 7.7 |
| 3 | 67.9 | 9.9 | 14.6 | 0.087 | 0.010 | 11.8 |
| 4 | 45.9 | 9.5 | 20.7 | 0.071 | 0.010 | 13.8 |
| 5 |