N/T PROTEIN CONTROL SL

K964065 · Behring Diagnostics, Inc. · JJY · Nov 6, 1996 · Clinical Chemistry

Device Facts

• Record ID: K964065
• Device Name: N/T PROTEIN CONTROL SL
• Applicant: Behring Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

N/T Protein Control SL is intended to be used as accuracy and precision controls in the determination of human serum proteins.

Device Story

N/T Protein Control SL is a liquid human serum-based quality control material containing stabilizers and preservatives. It serves as an accuracy and precision control for immunology assays performed on Behring Nephelometer systems and the TurbiTimeSystem. Laboratory personnel use the control to monitor the performance of protein determination assays. By comparing measured values against expected ranges, clinicians verify the reliability of patient serum protein test results, ensuring diagnostic accuracy for various protein-related conditions.

Clinical Evidence

Bench testing only. Precision and reproducibility studies conducted on Behring Nephelometer and TurbiTimeSystem. Percent CVs ranged from 0.6% to 8.2% on the Nephelometer and 1.6% to 6.1% on the TurbiTimeSystem. 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 control material with stabilizers and preservatives. Designed for use with nephelometric and turbidimetric immunoassay systems. Storage requirements: +2 to +8°C.

Indications for Use

Indicated for use as an accuracy and precision control for in vitro diagnostic determination of human serum proteins, including IgG, IgA, IgM, C3c, C4, Transferrin, Ceruloplasmin, RbP, Ig/L-chain Kappa, Ig/L-chain Lambda, IgG 1, IgG 2, Albumin, IgG 3, alpha1-antitrypsin, IgG 4, alpha2-macroglobulin, beta2-microglobulin, Haptoglobin, Ferritin, alpha1-acid glycoprotein, IgE, and Pre-albumin.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• N/T Protein Control SY

Reference Devices

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

Submission Summary (Full Text)

{0}

Behring Diagnostics Inc.
N/T Protein Control SL/L, M and H
510(k) Notification
K964065
NOV - 6 1996

# ATTACHMENT 2

## 510(k) SUMMARY FOR N/T PROTEIN CONTROL 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 9, 1996 |

2. Device Name/ Classification:

N/T Protein Control SL: quality control material
Classification Number: class I (862.1660)

3. Identification of the legally marketed device:

N/T Protein Control SY

4. Proposed Device Description:

The proposed control, N/T Protein Control SL is a control 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) and with the TurbiTimeSystem™ as accuracy and precision controls for the following tests:

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

CONFIDENTIAL
000008

{1}

Benning Diagnostics Inc.
N/T Protein Control SL/L, M and H
510(k) Notification

Albumin
IgG 3

α1-antitrypsin (α1-proteinase inhibitor)
IgG 4

α2-macroglobulin
β2-microglobulin

Haptoglobin
Ferritin

α1-acid glycoprotein
IgE

Pre-albumin (transthyretin)

## 5. Proposed Device Intended Use:

N/T Protein Control SL is intended to be used as accuracy and precision controls in the determination of human serum proteins.

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

N/T Protein Control SL is substantially equivalent in intended use to the N/T Protein Control SY. Both controls are *in vitro* diagnostic reagents intended for use as multi-constituent accuracy and precision controls in the determination of human serum proteins. The N/T Protein Control SY, like the proposed product, is a control in a blood based matrix. Also, both controls are used for accuracy and precision control in immunology assays.

The N/T Protein Control SL differs from the N/T Protein Control SY in that the N/T Protein Control SY is a lyophilized standard while the N/T Protein Control SL is a liquid control.

## 7. Proposed Device Performance Characteristics:

### Precision and reproducibility:

Precision studies using one lot of N/T Protein Control SL were run on the Behring Nephelometer system and on the TurboTimeSystem™. The percent CV's ranged from 0.6 to 8.2 % on the Behring Nephelometer system and from 1.6 to 6.1 % on the TurbiTimeSystem™.

### Stability

Stability was run according to in-house protocols and the control 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
00009