(59 days)
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quantex RF plus
No
The description details a traditional immunoassay based on agglutination and absorbance changes, with quantitation via a calibration curve. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic procedure used to measure RF in human serum, which aids in the diagnosis and treatment of rheumatoid arthritis. It does not directly treat or prevent a disease; rather, it provides information for diagnostic purposes.
Yes
The text explicitly states: "This in vitro diagnostic procedure is intended to quantitatively measure RF in human serum on the Cobas Mira chemistry analyzer. Such measurements are used in the diagnosis and treatment of rheumatoid arthritis." This indicates its purpose is for diagnosis.
No
The device is a reagent system, which is a chemical substance used in a laboratory test, not a software program. It is intended for use with a chemistry analyzer, which is a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic procedure is intended to quantitatively measure RF in human serum..."
- Device Description: The "Device Description" section further clarifies: "The RF-LATEX "SEIKEN" is a reagent system for the quantitation of the concentration of rheumatoid factor (RF) in human serum."
- Purpose: The intended use is to measure a substance (RF) in a sample taken from the human body (serum) to aid in the diagnosis and treatment of a medical condition (rheumatoid arthritis). This is the core definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This in vitro diagnostic procedure is intended to quantitatively measure RF in human serum on the Cobas Mira chemistry analyzer. Such measurements are used in the diagnosis and treatment of rheumatoid arthritis.
Product codes
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Device Description
The RF-LATEX "SEIKEN" is a reagent system for the quantitation of the concentration of rheumatoid factor (RF) in human serum, based on the agglutination of RF in serum with latex particles coated with anti-RF (human IgG), employing the absorbance change observed as the basis for quantitation, and calculating the amount of RF by interpolation from a calibration curve prepared from calibrators of known concentration. It is intended for use with the Cobas Mira chemistry analyzer (or other suitable analyzer).
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
human serum
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
ACCURACY
Ninety two serum samples with values spanning the reportable range for the assay were obtained and tested in parallel using the RF-LATEX "SEIKEN" and the quantex RF plus Reagent System.
Correlation: y = -0.947 + 1.053x, y = RF-LATEX "SEIKEN", x = quantex RF plus, r = 0.984, n = 92
PRECISION
Within run precision was determined by analyzing ten replicates each of five levels of commercial control serum. Between run precision was determined by analyzing three levels of commercial control serum once per day for ten days.
Within-run precision (C.V. %): 10.29 IU/ml (2.95%), 19.85 IU/ml (0.91%), 29.51 IU/ml (1.11%), 39.00 IU/ml (1.41%), 48.37 IU/ml (1.43%).
Between-run precision (C.V. %): Sample 1 (10.49 IU/ml, 1.59%), Sample 2 (19.86 IU/ml, 1.41%), Sample 3 (37.72 IU/ml, 1.62%).
LINEARITY
Linearity was determined by analyzing a series of six calibrators, covering the reportable range of the assay, with 3 separate lot numbers of reagents.
Regression (y = A + Bx): Average A = -0.29, Average B = 0.983, Average r = 0.9995.
STABILITY
Stability was determined by analyzing three levels of commercial control serum at three month intervals over the shelf life of two lot numbers of reagents.
Stability at 4 °C for Lot. 1 and Lot. 2 over 15 months, showing consistent values for Sample 1, Sample 2, and Sample 3.
Key Metrics
Min. Detectable Conc.: 3 IU/ml
Precision (Between-run): 20.3 IU/ml, 40.2 IU/ml, 59.2 IU/ml, less than 10%
Linearity: 3 - 120 IU/ml
Correlation: y = -0.947 + 1.053x, r = 0.984, n = 92
Minimal detectable concentration for the RF-LATEX "SEIKEN" is 3 IU/ml.
Maximum quantifiable concentration for the RF-LATEX "SEIKEN" system is 120 IU/ml.
Predicate Device(s)
Not Found
Reference Device(s)
quantex RF plus
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
APR 1 9 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
RF -LATEX "SEIKEN" on the Cobas Mira Chemistry Analyzer
Below summarizes and compares the performance of RF LATEX "SEIKEN" and a similar device previously given FDA clearance for marketing in the US. The information contained in this summary was obtained from data prepared at and which is on file at Denka Seiken, Co. Inc. The summary shows that the two reagent systems are substantially equivalent.
INTENDED USE
This in vitro diagnostic procedure is intended to quantitatively measure RF in human serum on the Cobas Mira chemistry analyzer. Such measurements are used in the diagnosis and treatment of rheumatoid arthritis.
| METHOD | RF-LATEX "SEIKEN" | quantex RF plus
BIOKIT USA, Inc.
113 Hartwell Avenue
Lexington, MA 02173 | |
|-------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------|
| Product Code | 602534 | 3000-2095 | |
| Min. Detectable Conc. | 3 IU/ml | 5 IU/ml | |
| Precision (Between-run) | 20.3 IU/ml
40.2 IU/ml
59.2 IU/ml | 5.23%
3.14%
1.26% | less than 10% |
| Linearity | 3 - 120 IU/ml | 5 - 100 IU/ml | |
| Correlation | y = -0.947 + 1.053x
y = RF-LATEX "SEIKEN"
x = quantex RF plus
r = 0.984
n = 92 | | |
1
The RF-LATEX "SEIKEN" and the quantex RF plus are similar in that both :
-
- Are reagent systems for the quantitation of the concentration of rheumatoid factor (RF) in human serum.
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- Are based on the agglutination of RF in serum with latex particles coated with anti-RF (human IgG).
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- Employ the absorbance change observed as the basis for quantitation.
- *Calculate the amount of RF by interpolation from a calibration curve prepared from calibrators of known concentration.
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- Are intended for use with the Cobas Mira chemistry analyzer (or other suitable analyzer).
The RF-LATEX "SEIKEN" and the quantex RF plus are different in that:
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- The minimal detectable concentration for the RF-LATEX "SEIKEN" is 3 IU/ml; that for the quantex RF plus is 5 IU/ml.
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- The maximum quantifiable concentration for the RF-LATEX "SEIKEN" system is 120 IU/ml; that for the quantex RF plus is 100 IU/ml.
The following further summarizes similarities and differences between the two reagent systems.
| RF | RF-LATEX "SEIKEN" | quantex RF plus |
|---|---|---|
| S.VOL (ul) | 6 | 6 |
| REAGENT VOL (R1) (ul) | 180 | 350 |
| START R1 VOL (R2) (ul) | 60 | 50 |
| CALC. STEP | ENDPOINT | ENDPOINT |
| STD | MULTI (5) | MULTI (4) |
| UNIT | IU/ml | IU/ml |
| WAVELENGTH | 550 nm | 550 nm |
2
PROTOCOL AND DATA SUMMARY
This section provides data generated by Denka Seiken Co., Ltd. characterizing the performance of the RF-LATEX "SEIKEN" Reagent System. The protocols used for data generation are given below, and the results are attached.
ACCURACY
Ninety two serum samples with values spanning the reportable range for the assay were obtained and tested in parallel using the RF-LATEX "SEIKEN" and the quantex RF plus Reagent System.
PRECISION
Within run precision was determined by analyzing ten replicates each of five levels of commercial control serum. Between run precision was determined by analyzing three levels of commercial control serum once per day for ten days.
LINEARITY
Linearity was determined by analyzing a series of six calibrators, covering the reportable range of the assay, with 3 separate lot numbers of reagents.
STABILITY
Stability was determined by analyzing three levels of commercial control serum at three month intervals over the shelf life of two lot numbers of reagents.
3
CORRELATION
Image /page/3/Figure/1 description: The image shows the text "quantex RF Plus / RF-LATEX "SEIKEN"" in a simple, sans-serif font. The text is arranged horizontally, with the words "quantex RF Plus" appearing first, followed by a forward slash and then "RF-LATEX". The word "SEIKEN" is enclosed in double quotation marks.
Image /page/3/Figure/2 description: This image is a scatter plot comparing "quantex RF plus" and "RF-LATEX 'SEIKEN'" measurements in IU/ml. The x-axis represents "quantex RF plus" and the y-axis represents "RF-LATEX 'SEIKEN'," both in IU/ml. A regression line is plotted through the data points, and the regression equation is given as y = a + bX, with a slope of 1.0532006 and an intercept of -0.94678. The correlation coefficient (r) is 0.9840, and the r-squared value is 0.9683, based on 92 cases.
7
4
RF-LATEX "SEIKEN"
PRECISION (WITHIN-RUN)
NO. OF CUPS SELECTED THAT WERE RUN = 10 RUN PRECISION ON CONC. DATA IN IU / ML
| SAMPLE NO. | MEAN | SD | C.V. % |
|---|---|---|---|
| 1 | 10.29 | 0.30 | 2.95 |
| 2 | 19.85 | 0.18 | 0.91 |
| 3 | 29.51 | 0.33 | 1.11 |
| 4 | 39.00 | 0.55 | 1.41 |
| 5 | 48.37 | 0.69 | 1.43 |
PRECISION (BETWEEN-RUN )
| DAY | IU/ml | ||
|---|---|---|---|
| Sample 1 | Sample 2 | Sample 3 | |
| 1 | 10.5 | 19.6 | 38.0 |
| 2 | 10.6 | 20.1 | 37.6 |
| 3 | 10.6 | 19.8 | 37.2 |
| 4 | 10.2 | 19.7 | 37.8 |
| 5 | 10.4 | 20.1 | 37.8 |
| 6 | 10.5 | 19.5 | 37.0 |
| 7 | 10.8 | 20.4 | 39.2 |
| 8 | 10.5 | 19.9 | 37.6 |
| 9 | 10.5 | 19.9 | 37.2 |
| 10 | 10.3 | 19.6 | 37.8 |
| Average | 10.49 | 19.86 | 37.72 |
| SD | 0.17 | 0.28 | 0.61 |
| C.V. % | 1.59 | 1.41 | 1.62 |
5
LINEARITY
| IU/ml | IU/ml | |||
|---|---|---|---|---|
| Lot. 1 | Lot. 2 | Lot.3 | Average | |
| 20.0 | 10.4 | 10.0 | 9.3 | 9.9 |
| 40.0 | 19.3 | 21.2 | 19.0 | 19.8 |
| 60.0 | 28.1 | 28.2 | 28.4 | 28.2 |
| 80.0 | 39.1 | 38.6 | 38.7 | 38.8 |
| 100.0 | 47.6 | 49.0 | 49.7 | 48.8 |
| 120.0 | 59.3 | 60.0 | 58.4 | 59.2 |
| A = | -0.07 | 0.12 | -0.87 | -0.29 |
| B = | 0.973 | 0.982 | 0.994 | 0.983 |
| r = | 0.9989 | 0.9996 | 0.9996 | 0.9995 |
| $y = A + Bx$ |
STABILITY Stored at 4 °C
| MONTH | Lot. 1 (IU/ml) | Lot.2 (IU/ml) | ||||
|---|---|---|---|---|---|---|
| Sample 1 | Sample 2 | Sample 3 | Sample 1 | Sample 2 | Sample 3 | |
| 0 | 10.2 | 19.4 | 39.5 | 11.8 | 18.4 | 39.7 |
| 3 | 10.4 | 19.3 | 39.3 | 9.3 | 18.4 | 38.6 |
| 6 | 10.4 | 19.9 | 37.7 | 9.7 | 18.2 | 39.3 |
| 12 | 10.7 | 19.2 | 37.4 | 9.8 | 17.8 | 37.6 |
| 15 | 10.0 | 19.0 | 36.3 | 9.5 | 17.6 | 38.1 |