N CRP STANDARD SY

K962406 · Behring Diagnostics, Inc. · JIX · Jul 16, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962406
• Device Name: N CRP STANDARD SY
• Applicant: Behring Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jul 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

N CRP Standard SY is intended to be used for the establishment of reference curves.

Device Story

N CRP Standard SY is a lyophilized human serum-based calibrator containing stabilizers and preservatives. Used with Behring Nephelometer systems (K860894, K892223, K943997) to calibrate N Latex CRP mono tests. Operates by establishing reference curves for immunology assays. Used in clinical laboratory settings by trained personnel. Provides standardized reference values to ensure accurate quantification of C-reactive protein (CRP) levels in patient samples, aiding clinical diagnosis and monitoring of inflammatory conditions.

Clinical Evidence

Bench testing only. Precision studies on Behring Nephelometer yielded %CVs ranging from 1.43% to 4.47%. Stability testing confirmed shelf life of at least 12 months (lyophilized) and 4 weeks (reconstituted).

Technological Characteristics

Lyophilized human serum matrix with stabilizers and preservatives. Single-analyte calibrator. Designed for use with nephelometric immunoassay systems.

Indications for Use

Indicated for use as a calibrator for the establishment of reference curves in immunology assays performed on Behring Nephelometer systems.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• N Protein Standard SY

Reference Devices

• Behring Nephelometer (K860894)
• Behring Nephelometer 100 (K892223)
• Behring Nephelometer II (K943997)

Submission Summary (Full Text)

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K962400

JUL 16 1996

Attachment 1

510(k) Summary of Safety and Effectiveness for N CRP Standard SY

1. Manufactures Name, Address, Telephone, and contact person, date of preparation:

Manufacture
Behringwerke AG
Postfach 1140
35001 Marburg
Germany

Distributor
Behring Diagnostics Inc.
151 University Avenue
Westwood, MA 02090
617-320-3000
Attn: Kathleen Dray-Lyons

Preparation date: June 19, 1996

2. Device Name/ Classification:
N Protein Standard SY: calibrator
Classification Number: class II (862.1150)

3. Identification of the legally marketed device:
N Protein Standard SY

4. Proposed Device Description:
The proposed calibrator, N CRP Standard SY is a calibrator prepared from human serum (lyophilized) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer Systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer II K943997) for the calibration of the N Latex CRP mono test.

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5. Proposed Device Intended Use:

N CRP Standard SY is intended to be used for the establishment of reference curves.

6. Medical device to which equivalence is claimed and comparison information.

The N CRP Standard SY is substantially equivalent in intended use to the N Protein Standard SY. Both standards are *in vitro* diagnostic reagents intended for use as a calibrator for the establishment of reference curves. The N CRP Standard SY like the N Protein Standard SY is a standard in a blood based matrix. Also, both standard are used for the calibration of immunology assays.

The N CRP Standard SY differs from the N Protein Standard SY in that the N Protein Standard SY is a multi-analyte calibrator while the N CRP Standard SY is a single analyte calibrator.

7. Proposed Device Performance Characteristics:

Precision and reproducibility:

Precision studies using one lot of N CRP Standard SY were run on the Behring Nephelometer. The %CVs ranged from 1.43 to 4.47%.

Stability

Stability was run according to in-house protocols and the control was found stable for at least 12 month lyophilized and 4 weeks once reconstituted.

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