(41 days)
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No
The device description and performance studies focus on a traditional immunoassay method using light scattering and comparison to standards, with no mention of AI or ML.
No.
The device is an in vitro diagnostic reagent used to quantify C-reactive protein in human serum, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as an "in vitro diagnostic reagent" intended for the "quantitative determination of C-reactive protein in human serum," which is a diagnostic purpose.
No
The device is described as a "test reagent" and involves "polystyrene particles coated with mouse monoclonal Y antibodies," which are physical components, not software. It is used with a "Behring Nephelometer System," which is also a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum." This clearly indicates its purpose is for diagnostic testing performed outside of the body (in vitro) using a biological sample (human serum).
- Device Description: The description further elaborates on how the reagent works to measure C-reactive protein in human serum, which is a typical function of an in vitro diagnostic test.
- Anatomical Site: The specified anatomical site is "human serum," which is a biological sample used for in vitro testing.
The information provided aligns perfectly with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum.
Product codes
866.5270
Device Description
The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative defermination of C-reactive protein in human serum.
In the proposed product polystyrene particles coated with mouse monoclonal Y antibodies to C-reactive protein are agglutinated when mixed with samples containing C-reactive proteins. The intensity of the resulting scattered light in the nephelometer is dependent upon the C-reactive protein content so that, by comparison to standards of known concentration the C-reactive protein content of a sample can be determined.
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
Results of comparative studies using the N Latex CRP mono Reagent and the N Latex CRP test kit for 71 serum samples qave a correlation coefficient of 0.98 and a y-intersept of 1.43, and a slope of 0.95.
N Latex CRP mono Reagent was used to measure 3 different CRP concentrations (approx. 15, 25 and 60 mg/l) and yielded coefficients of variation of 4.0%, 2.3% and 4.4% for the intra-assay precision (n = 20).
Five CRP concentrations (approx. 10, 15, 25, 45 and 60 mg/l) were used to determine the inter-assay reproducibility (n = 10) and here the coefficients of variation ranged from 2,6 % to 5.7 %.
Key Metrics
Correlation coefficient: 0.98
y-intercept: 1.43
slope: 0.95
Intra-assay precision (coefficients of variation): 4.0%, 2.3%, 4.4%
Inter-assay reproducibility (coefficients of variation): 2.6% to 5.7%
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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JUL 10 1998
Attachment 1
510(k) Summary of Safety and Effectiveness for N Latex CRP mono Reagent
1. Manufacturer Name, Adress, phone number, contact name and date of preparation:
- Manufacturer: Behrinawerke AG. Postfach 1140 35001 Marburg Germany
- Distributor: Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617 - 320 - 3023 Contact name: Kathleen Dray-Lyons
date of preparation: May 29, 1996
2. Device name/Classification:
In vitro diagnostic reagents for the quantitative determination of C-reactive protein (CRP) Class II (866.5270).
3. ldentification of the legally marketed device to which the submitter claims equivalence:
The Behringwerke N Latex CRP (K860894)
4. Proposed Device Description:
The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative defermination of C-reactive protein in human serum.
In the proposed product polystyrene particles coated with mouse monoclonal Y antibodies to C-reactive protein are agglutinated when mixed with samples containing C-reactive proteins. The intensity of the resulting scattered light in the nephelometer is dependent upon the C-reactive protein content so that, by comparison to standards of known concentration the C-reactive protein content of a sample can be determined.
1
5. Proposed Device Intended Use:
The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum.
6. Medical device to which equivalence is claimed and comparison information:
The N Latex CRP mono Reagent is substantially equivalent in intended use and results obtained to N Latex CRP. The N CRP Reagent, like the proposed product is intended to be used for the quantitative determination of C-reactive protein in human serum by particle enhanced nephelometry
The N Latex CRP mono Reagent differs from the N Latex CRP in that the N Latex CRP mono Reagent is calibrated using a lot independent standard, whereas the N CRP Reagent is calibrated using a lot dependent standard (included in the kit). Also. the N Latex CRP mono Reagent is a liquid reagent consisting of polystyrene particles coated with mouse monoclonal antibodies to CRP, where as the N CRP Reagent is a lyphilized reagent containing polystyrene particles which are coated with antibodies of the y-fraction from a specific rabbit anti-human-CRP serum. Additionally, the N Latex CRP mono Reagent is designed to measure CRP concentrations within an overall range of approx. 0.175 - 1100 mg/l , whereas, the N Latex CRP measuring range is approx. 0.625 - 800 mg/l. A copy of the N Latex CRP Reagent package insert is included in this submission.
7. Proposed Device Performance Characteristics:
Correlation
Results of comparative studies using the N Latex CRP mono Reagent and the N Latex CRP test kit for 71 serum samples qave a correlation coefficient of 0.98 and a y-intersept of 1.43, and a slope of 0.95.
Precision
N Latex CRP mono Reagent was used to measure 3 different CRP concentrations (approx. 15, 25 and 60 mg/l) and yielded coefficients of variation of 4.0%, 2.3% and 4.4% for the intra-assay precision (n = 20).
Five CRP concentrations (approx. 10, 15, 25, 45 and 60 mg/l) were used to determine the inter-assay reproducibility (n = 10) and here the coefficients of variation ranged from 2,6 % to 5.7 %.