(59 days)
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No
The description focuses on a reagent system and its performance characteristics, with no mention of AI or ML.
No.
The device is an in vitro diagnostic procedure intended to quantitatively measure CRP in human serum, which is used for diagnosis and treatment of bacterial infections and inflammation, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic procedure is intended to quantitatively measure CRP in human serum... Such measurements are used in the diagnosis and treatment of bacterial infections and inflammation," clearly indicating its diagnostic purpose.
No
The device description clearly states it is a "reagent system" based on "latex particles" and measures "absorbance change," indicating a physical, chemical-based in vitro diagnostic device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: Explicitly states "This in vitro diagnostic procedure is intended to quantitatively measure CRP in human serum..." and that these measurements are used in diagnosis and treatment.
- Device Description: Describes the device as "reagent systems for the quantitation of the concentration of CRP in human serum."
- Nature of the Test: The test is performed on a human sample (serum) in vitro (outside the body) to provide information for diagnosis and treatment.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This in vitro diagnostic procedure is intended to quantitatively measure CRP in human serum on the Cobas Mira chemistry analyzer . Such measurements are used in the diagnosis and treatment of bacterial infections and inflammation.
Product codes (comma separated list FDA assigned to the subject device)
600554
Device Description
The CRP-LATEX "SEIKEN" XR is a reagent system for the quantitation of the concentration of CRP in human serum. It is based on the agglutination of CRP in serum with latex particles coated with anti-CRP, and employs the absorbance change observed as the basis for quantitation. It is intended for use with the Cobas Mira chemistry analyzer and uses a multistandard calibration curve (0, 1, 5, 10, 15, 20 mg/dl). The minimal detectable concentration is 0.1 mg/dl and the maximum quantifiable concentration is 20.0 mg/dl. The wavelength for measurement is 550 nm.
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)
ACCURACY
Study Type: Correlation study
Sample Size: 122 serum samples
Key Results: Correlation with predicate device (quantex CRP plus). Regression equation: y = 0.0054380 + 1.1258245X, r = 0.9976.
PRECISION
Study Type: Within-run and Between-run precision study.
Sample Size:
Within-run: 10 replicates for each of five levels of commercial control serum.
Between-run: 3 levels of commercial control serum, once per day for 10 days.
Key Results:
Within-run: CV% ranged from 2.02% to 3.77%.
Between-run: For Sample 1 (Average 1.03 mg/dl), SD = 0.02, CV% = 1.94%. For Sample 2 (Average 5.03 mg/dl), SD = 0.11, CV% = 2.24%. For Sample 3 (Average 9.99 mg/dl), SD = 0.16, CV% = 1.58%.
LINEARITY
Study Type: Linearity study.
Sample Size: A series of twelve calibrators for three separate lot numbers of reagents.
Key Results: Linearity from 0.1 to 20.0 mg/dl. Correlation coefficients (r) for the three lots were 0.9998, 0.9996, and 0.9998. Average r = 0.9998.
STABILITY
Study Type: Stability study.
Sample Size: Three levels of commercial control serum measured at three-month intervals.
Key Results: Data provided for Lot. 1 and Lot. 2 over 15 months, showing consistent results compared to initial measurements. Stability was determined for reagents stored at 4 degrees C.
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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§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
0
APR 19 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
CRP-LATEX "SEIKEN" XR on the Cobas Mira Chemistry Analyzer
Below summarizes and compares the performance of CRP-LATEX "SEIKEN" XR 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. This summary shows that the two reagent systems are substantially equivalent.
INTENDED USE
This in vitro diagnostic procedure is intended to quantitatively measure CRP in human serum on the Cobas Mira chemistry analyzer . Such measurements are used in the diagnosis and treatment of bacterial infections and inflammation.
| METHOD | CRP-LATEX "SEIKEN" XR | K904312
quantex CRP plus
BIOKIT USA, Inc.
113 Hartwell Avenue
Lexington, MA 02173 | |
|-------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------|
| Product Code | 600554 | 3000-2092 | |
| Min. Detectable Conc. | 0.1 mg/dl | 0.3 mg/dl | |
| Precision (Between-run) | 1.03 mg/dl
5.03 mg/dl
9.99 mg/dl | 1.94%
2.24%
1.58% | less than 10% |
| Linearity | 0.1 - 20.0 mg/dl | 0.3 - 10.0 mg/dl | |
| Correlation | y = 0.005 + 1.126X
y = CRP-LATEX "SEIKEN" XR
x = quantex CRP plus
n = 122
r = 0.9976 | | |
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The CRP-LATEX "SEIKEN" XR and the quantex CRP plus are similar in that both:
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- Are reagent systems for the quantitation of the concentration of CRP in human serum.
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- Are based on the agglutination of CRP in serum with latex particles coated with anti-CRP.
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- Employ the absorbance change observed as the basis for quantitation.
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- Are intended for use with the Cobas Mira chemistry analyzer.
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
The CRP-LATEX "SEIKEN" XR and the quantex CRP plus are different in that:
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- The CRP-LATEX "SEIKEN" uses a multistandard calibration curve and the quantex CRP plus a single point calibrator as the basis for calculating the concentration of CRP.
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- The minimal detectable concentration for the CRP-LATEX "SEIKEN" XR is 0.1 mg / dl; that for the quantex CRP plus is 0.3 mg / dl.
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- The maximum quantifiable concentration for the CRP-LATEX "SEIKEN" XR is 20.0 mg / dl; that for the Biokit system is 10.0 mg / dl
The following further summarizes similarities and differences between the two reagent systems.
| CRP | CRP-LATEX "SEIKEN" XR | quantex CRP plus |
|---|---|---|
| S.VOL (ul) | 4 | 3 |
| REAGENT VOL (R1) (ul) | 150 | 350 |
| START R1 VOL (R2) (ul) | 85 | 80 |
| START R2 VOL (R2) (ul) | -- | 80 |
| CALC.STEP | RATE | ENDPOINT |
| STD | MULTI | |
| (0,1,5,10,15,20) | 1 POINT | |
| UNIT | mg/dl | mg/dl |
| WAVELENGTH | 550 nm | 550 nm |
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PROTOCOL AND DATA SUMMARY
This section provides data generated by Denka Seiken Co., Ltd. characterizing the performance of the CRP-LATEX "SEIKEN" XR Reagent System. The protocols used for data generation are given below, and the results are attached.
ACCURACY
One hundred and twenty two serum samples with values spanning the reportable range for the assay were obtained and tested in parallel using the CRP-LATEX "SEIKEN" XR and the quantex CRP 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 twelve calibrators, covering the reportable range of the assay, with three separate lot numbers of reagents.
STABILITY
Stabillity was determined by analyzing three levels of commercial control serum at three month intervals over the shelf life of two lot numbers of reagents.
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CORRELATION
Image /page/3/Figure/1 description: This image is a scatter plot that shows the correlation between two different methods of measuring C-reactive protein (CRP). The x-axis represents the quantex CRP plus method, and the y-axis represents the CRP-LATEX "SEIKEN" method, both measured in mg/dl. The data points are clustered tightly around a straight line, indicating a strong positive correlation between the two methods. The correlation is described as quantex CRP plus / CRP-LATEX "SEIKEN".
quantex CRP plus / CRP-LATEX "SEIKEN"
NUMBER OF CASES : 122 REGRESSION EQUATION : y = a + bX INTERCEPT (a) = 0.0054380 SLOPE (b) = 1.1258245 r = 0.9976 r
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CRP-LATEX "SEIKEN" XR
PRECISION (WITHIN-RUN)
NO. OF CUPS SELECTED THAT WERE RUN = 10 RUN PRECISION ON CONC. DATA IN MG / DL
| SAMPLE NO. | MEAN | SD | C.V. % |
|---|---|---|---|
| 1 | 1.06 | 0.04 | 3.36 |
| 2 | 3.09 | 0.07 | 2.35 |
| 3 | 5.10 | 0.10 | 2.02 |
| 4 | 10.01 | 0.32 | 3.20 |
| 5 | 15.02 | 0.57 | 3.77 |
PRECISION (BETWEEN-RUN)
1.6.00 ﺮ
| mg/dl | |||
|---|---|---|---|
| DAY | Sample 1 | Sample 2 | Sample 3 |
| 1 | 1.04 | 4.85 | 10.14 |
| 2 | 1.05 | 5.02 | 9.69 |
| 3 | 1.05 | 5.14 | 10.16 |
| 4 | 1.01 | 5.03 | 9.82 |
| 5 | 1.06 | 4.96 | 9.99 |
| 6 | 1.02 | 5.14 | 9.85 |
| 7 | 1.03 | 5.13 | 10.02 |
| 8 | 1.02 | 5.11 | 10.08 |
| 9 | 1.05 | 4.85 | 9.99 |
| 10 | 1.00 | 5.09 | 10.15 |
| Average | 1.03 | 5.03 | 9.99 |
| SD | 0.02 | 0.11 | 0.16 |
| C.V. % | 1.94 | 2.24 | 1.58 |
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LINEARITY
| mg/dl | Lot. 1 | Lot. 2 | Lot.3 | Average |
|---|---|---|---|---|
| 0.50 | 0.57 | 0.54 | 0.42 | 0.51 |
| 1.00 | 1.06 | 1.10 | 1.03 | 1.06 |
| 2.00 | 2.06 | 2.10 | 2.11 | 2.09 |
| 4.00 | 3.91 | 3.87 | 3.97 | 3.92 |
| 6.00 | 5.71 | 5.76 | 5.75 | 5.74 |
| 8.00 | 7.94 | 7.79 | 7.95 | 7.89 |
| 10.00 | 9.76 | 9.78 | 9.87 | 9.80 |
| 12.00 | 11.58 | 11.25 | 11.75 | 11.53 |
| 14.00 | 13.64 | 13.86 | 13.68 | 13.73 |
| 16.00 | 15.86 | 15.65 | 15.93 | 15.81 |
| 18.00 | 17.87 | 17.80 | 18.06 | 17.91 |
| 20.00 | 19.76 | 19.76 | 19.62 | 19.71 |
| A = | -0.007 | -0.009 | -0.010 | -0.009 |
| B = | 0.985 | 0.981 | 0.989 | 0.985 |
| r = | 0.9998 | 0.9996 | 0.9998 | 0.9998 |
| y = A + B x |
9
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6
STABILITY Stored at 4 ℃ .
| MONTH | Lot. 1 (mq/dl) | Lot.2 (mq/dl) | ||||
|---|---|---|---|---|---|---|
| Sample 1 | Sample 2 | Sample 3 | Sample 1 | Sample 2 | Sample 3 | |
| 0 | 1.07 | 5.21 | 10.31 | 1.08 | 4.93 | 9.72 |
| 3 | 1.07 | 4.83 | 10.02 | 0.96 | 5.17 | 10.59 |
| 6 | 0.99 | 5.33 | 10.30 | 0.99 | 5.04 | 10.06 |
| 12 | 0.93 | 5.10 | 9.98 | 1.03 | 4.94 | 9.90 |
| 15 | 1.02 | 5.16 | 10.45 | 1.05 | 5.05 | 9.77 |
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