N LATEX CRP MONO REAGENT
K964687 · Behring Diagnostics, Inc. · DCH · Dec 16, 1996 · Immunology
Device Facts
| Record ID | K964687 |
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| Device Name | N LATEX CRP MONO REAGENT |
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| Applicant | Behring Diagnostics, Inc. |
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| Product Code | DCH · Immunology |
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| Decision Date | Dec 16, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 866.5270 |
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| Device Class | Class 2 |
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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.
Device Story
In vitro diagnostic reagent; used with Behring Nephelometer Systems. Input: human serum or plasma samples. Principle: polystyrene particles coated with mouse monoclonal anti-CRP antibodies; agglutination occurs in presence of CRP; scattered light intensity measured by nephelometer. Output: quantitative CRP concentration determined via comparison to known standards. Used in clinical laboratory settings by trained personnel. Results assist healthcare providers in assessing inflammatory states. Benefit: provides rapid, accurate quantitative CRP measurement for clinical decision-making.
Clinical Evidence
Bench testing only. Comparative study of serum vs. plasma (EDTA and heparin) samples. Correlation coefficients: 0.998 (EDTA) and 0.999 (heparin). Slopes: 0.979 (EDTA) and 0.989 (heparin). Y-intercepts: 0.166 (EDTA) and 0.79 (heparin).
Technological Characteristics
Particle-enhanced nephelometric immunoassay. Reagent consists of polystyrene particles coated with mouse monoclonal antibodies. Energy source: nephelometer light source. Connectivity: integrated with Behring Nephelometer Systems.
Indications for Use
Indicated for the quantitative determination of C-reactive protein in human serum or plasma using particle-enhanced nephelometry.
Regulatory Classification
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.
Predicate Devices
- N Latex CRP mono Reagent (K962523)
Related Devices
- K962523 — N LATEX CRP MONO REAGENT · Behring Diagnostics, Inc. · Jul 10, 1996
- K033908 — N HIGH SENSITIVITY CRP · Dade Behring, Inc. · Jan 22, 2004
- K070626 — SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT · Beckman Coulter, Inc. · May 4, 2007
- K232624 — CardioPhase® hsCRP · Siemens Healthcare Diagnostic Products GmbH · Nov 27, 2023
Submission Summary (Full Text)
{0}
Behring Diagnostics Inc.
N Latex CRP mono Reagent
510(k) Notification
K964687
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
00008
{1}
Behring Diagnostics Inc.
N Latex CRP mono Reagent
510(k) Notification
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.
CONFIDENTIAL
000009
