(90 days)
Not Found
No
The description focuses on a reagent and a nephelometer system for quantitative determination based on light scattering, with no mention of AI/ML terms or functionalities.
No.
Explanation: The device is an in vitro diagnostic reagent used to quantitatively determine C-reactive protein, not to treat any condition.
Yes
The "Intended Use" explicitly states that the proposed test reagent is "an in vitro diagnostic reagent," which directly indicates its diagnostic purpose.
No
The device is described as an in vitro diagnostic reagent, which is a chemical substance used in laboratory tests. It is intended to be used with a Behring Nephelometer System, which is a hardware instrument. The description focuses on the chemical reaction and the measurement of scattered light, indicating a physical component and process, not solely software.
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 or plasma." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details how the reagent works by reacting with C-reactive proteins in a sample (serum or plasma) to produce a measurable result (scattered light intensity) that is then used to determine the concentration of the protein. This process is performed in vitro (outside the living body).
The information provided clearly indicates that this reagent is designed to be used in a laboratory setting to analyze human biological samples for diagnostic purposes, which is the core function of an IVD.
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 or plasma.
Product codes
Not Found
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 determination of C-reactive protein in human serum or plasma. In the proposed product polystyrene particles coated with mouse monoclonal 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
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
Results of comparative serum versus plasma studies for both EDTA and heparin plasma samples using the N Latex CRP mono reagent gave correlation coefficients of 0.998 and 0.999, respectively, y-intercepts of 0.166 and 0.79, respectively, and slopes of 0.979 and 0.989, respectively.
Key Metrics
correlation coefficients of 0.998 and 0.999, respectively, y-intercepts of 0.166 and 0.79, respectively, and slopes of 0.979 and 0.989, respectively.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
" Behring Diagnostics Inc. N Latex CRP mono Reagent 510(k) Notification
DEC ,
. Эдв
DEC 1 6 1996
510(k) Summary of Safety and Effectiveness for the Behring N Latex CRP mono Reagent
1. Manufacturer Name, Address, phone number, contact name and date of preparation:
- Manufacturer: Behringwerke AG, Postfach 1140 35001 Marburg Germany
- Distributor: Behring Diagnostics Inc. 151 University Avenue Westwood. MA 02090 617 - 320 - 3153 Contact name: Laura LeBarron
Date of preparation: September 11, 1996
2. Device name/Classification:
In vitro diagnostic reagents for the quantitative determination of C-reactive protein (CRP) Class II (866.5270).
3. Identification of the legally marketed device to which the submitter claims equivalence:
The Behringwerke N Latex CRP mono Reagent (K962523)
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 determination of C-reactive protein in human serum or plasma.
CONFIDENTIAL
1
In the proposed product polystyrene particles coated with mouse monoclonal 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.
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 or plasma.
6. Medical device to which equivalence is claimed and comparison information:
The N Latex CRP mono Reagent for use with serum or plasma samples is substantially equivalent in intended use and results obtained to the N Latex CRP mono Reagent (K962523) for use with serum samples. The N Latex CRP mono Reagent is intended to be used for the quantitative determination of C-reactive protein in human serum or plasma by particle enhanced nephelometry.
7. Proposed Device Performance Characteristics:
Correlation
Results of comparative serum versus plasma studies for both EDTA and heparin plasma samples using the N Latex CRP mono reagent gave correlation coefficients of 0.998 and 0.999, respectively, y-intercepts of 0.166 and 0.79, respectively, and slopes of 0.979 and 0.989, respectively.