(23 days)
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No
The description details a standard immunoturbidimetric assay and does not mention any AI or ML components.
No
This device is an in vitro diagnostic assay used for quantitative determination of rheumatoid factors, which is an aid in diagnosis and not a therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements may be used as an aid in the diagnosis of rheumatoid arthritis," which indicates its role in diagnosis.
No
The device description clearly states it is a "particle enhanced immunoturbidimetric assay" and involves "Latex-bound heat inactivated IgG (antigen)" reacting with "RF-antibodies in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically." This describes a chemical assay and a physical measurement process, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro quantitative determination of rheumatoid factors in human serum and plasma". This indicates the test is performed outside of the body using biological samples.
- Device Description: The description details a "particle enhanced immunoturbidimetric assay" that measures "antigen/antibody complexes" formed by reacting the sample with reagents. This is a typical description of an in vitro diagnostic test.
- Regulatory Context: The presence of a Predicate Device with a K number (K002609) strongly suggests this device has gone through a regulatory submission process for IVDs.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoturbidimetric assay for the in vitro quantitative determination of rheumatoid factors in human serum and plasma on automated clinical chemistry analyzers. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis.
Product codes (comma separated list FDA assigned to the subject device)
DHR
Device Description
The Tina-quant® Rheumatoid Factors II Test System is a particle enhanced immunoturbidimetric assay. Latex-bound heat inactivated IgG (antigen) reacts with the RF-antibodies in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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 1 0 2003
510(k) Summary - Tina-quant® RF II Test System
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter name, address, contact | Roche Diagnostics Corporation |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3831 |
Contact person: Sherri L. Coenen
Date prepared: August 8, 2003 |
| Device Name | Proprietary name: Tina-quant® Rheumatoid Factors II Test System
Common name: Tina-quant® RF II
Classification name: Rheumatoid Factor Test System |
| Device description | The Tina-quant® Rheumatoid Factors II Test System is a particle enhanced immunoturbidimetric assay. Latex-bound heat inactivated IgG (antigen) reacts with the RF-antibodies in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically. |
| Intended use | Immunoturbidimetric assay for the in vitro quantitative determination of rheumatoid factors in human serum and plasma on automated clinical chemistry analyzers. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis. |
| Predicate Device | We claim substantial equivalence to the currently marketed Tina-quant® Rheumatoid Factors II Test System. (K002609). |
1
510(k) Summary - COBAS Integra Creatinine plus ver.2,
continued
The following table describes the similarities and differences between the Reagent Summary Tina-quant® Rheumatoid Factors II Test System and the predicate device.
| Topic | Tina-quant® RF II (K002609) | Tina-quant® RF II (Modified Device) |
|---|---|---|
| Intended Use | Immunoturbidimetric assay for the quantitative in vitro determination of rheumatoid factors in human serum on automated clinical chemistry analyzers. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis. | Immunoturbidimetric assay for the quantitative in vitro determination of rheumatoid factors in human serum and plasma on automated clinical chemistry analyzers. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis. |
| Method | Particle-enhanced | |
| immunoturbidimetric assay | Same | |
| Sample type | Serum | Serum |
| Li/Na Heparin, Na2/K2/K3 EDTA- | ||
| Plasma | ||
| Measuring | ||
| range | 3 - 120.0 IU/ml | 7 - 103 IU/ml |
| Expected | ||
| values |