N PROTEIN STRANDARD SL

K964062 · Behring Diagnostics, Inc. · JIX · Nov 21, 1996 · Clinical Chemistry

Device Facts

• Record ID: K964062
• Device Name: N PROTEIN STRANDARD SL
• Applicant: Behring Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

N Protein Standard SL is intended to be used for the establishment of reference curves.

Device Story

N Protein Standard SL is a liquid human serum-based calibrator containing stabilizers and preservatives. Used with Behring Nephelometer systems (K860894, K892223, K943997) to establish reference curves for various protein assays. Operates by providing known concentrations to calibrate nephelometric immunology assays. Used in clinical laboratory settings by trained personnel. Output allows healthcare providers to quantify specific protein levels in patient samples, aiding in diagnosis and monitoring of protein-related conditions.

Clinical Evidence

Bench testing only. Precision studies on Behring Nephelometer yielded CVs ranging from 0.9% to 3.9%. Stability testing confirmed shelf life of at least 12 months at +2 to +8°C (unopened) and 15 days at +2 to +8°C (opened).

Technological Characteristics

Liquid human serum-based calibrator; contains stabilizers and preservatives. Designed for use with nephelometric systems. Stable for 12 months at 2-8°C.

Indications for Use

Indicated for use as a multi-constituent calibrator for in vitro diagnostic immunology assays on Behring Nephelometer systems to establish reference curves for proteins including IgG, IgA, IgM, C3c, C4, Transferrin, Albumin, Ceruloplasmin, RbP, Kappa/Lambda light chains, alpha-1-antitrypsin, alpha-2-macroglobulin, Haptoglobin, alpha-1-acid glycoprotein, Pre-albumin, beta-2-microglobulin, Ferritin, and IgE.

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)

{0}

Behring Diagnostics Inc.
N Protein Standard SL
510(k) Notification
K964062
NOV 21 1996

# ATTACHMENT 2

# 510(k) SUMMARY FOR N PROTEIN STANDARD SL

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

Contact Person: Laura LeBarron
Date of Preparation: October 4, 1996

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

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

4. Proposed Device Description:
The proposed standard, N Protein Standard SL is a standard prepared from human serum (liquid) 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) to establish reference curves for the following tests:

IgG Ceruloplasmin
IgA RbP
IgM Ig/L-chain, Kappa
C3c Ig/L-chain, Lambda
C4 IgG 1
Transferin IgG 2
Albumin IgG 3

CONFIDENTIAL
000008

{1}

Behring Diagnostics Inc.
N Protein Standard SL
510(k) Notification

Albumin
α1-antitrypsin (α1-proteinase inhibitor)
α2-macroglobulin
Haptoglobin
α1-acid glycoprotein
Pre-albumin (transthyretin)

IgG 3
IgG 4
β2-microglobulin
Ferritin
IgE

5. Proposed Device Intended Use:

N Protein Standard SL is intended to be used for the establishment of reference curves.

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

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

The N Protein Standard SL differs from the N Protein Standard SY in that the N Protein Standard SY is a lyophilized standard while the N Protein Standard SL is a liquid standard.

7. Proposed Device Performance Characteristics:

Precision and reproducibility:

Precision studies using one lot of N Protein Standard SL were run on the Behring Nephelometer. The percent CVs ranged from 0.9 to 3.9 %.

Stability

Stability was run according to in-house protocols and the standard was found to be stable for at least 12 months at +2 to +8°C, as originally packaged and for at least 15 days at +2 to +8°C, once opened.

CONFIDENTIAL
300079