N/T PROTEIN CONTROL PY

K962407 · Behring Diagnostics, Inc. · GIL · Jul 29, 1996 · Hematology

Device Facts

• Record ID: K962407
• Device Name: N/T PROTEIN CONTROL PY
• Applicant: Behring Diagnostics, Inc.
• Product Code: GIL · Hematology
• Decision Date: Jul 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7340
• Device Class: Class 2

Intended Use

N/T Protein Control PY is used for control of accuracy and precision in the quantitative immunochemical determination of alpha₁-Antitrypsin, fibrinogen, antithrombin III, prothrombin, plasminogen, fibronectin*, C₁ Inhibitor with the Behring Nephelometer Systems and with the TurbiTimeSystem. *not available in the U.S.

Device Story

N/T Protein Control PY is a lyophilized, human citrate plasma-based quality control material. It contains specific proteins: fibrinogen, antithrombin III, prothrombin, plasminogen, alpha₁-Antitrypsin, and C₁ Inhibitor. Used in clinical laboratories to monitor accuracy and precision of quantitative immunochemical determinations performed on Behring Nephelometer Systems and TurbiTimeSystem. Healthcare providers use the provided lot-specific table of values to verify instrument performance. The control helps ensure reliable clinical decision-making by validating the consistency of coagulation and protein assay results.

Clinical Evidence

Bench testing only. Precision and reproducibility studies conducted on Behring Nephelometer using 10 vials of one lot, tested in triplicate. %CVs ranged from 1.11% to 2.72%. Stability testing confirmed 12-month shelf life for lyophilized product and 14-day stability post-reconstitution.

Technological Characteristics

Lyophilized human citrate plasma matrix. Multi-constituent control containing fibrinogen, antithrombin III, prothrombin, plasminogen, alpha₁-Antitrypsin, and C₁ Inhibitor. Designed for use with nephelometric and turbidimetric systems.

Indications for Use

Indicated for use as a quality control material to monitor laboratory coagulation and protein procedures in clinical settings.

Regulatory Classification

Identification

A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

Special Controls

*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Control Plasma N

Submission Summary (Full Text)

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JUL 29 1996
K 96 2407

# Attachment 1

# 510(k) Summary of Safety and Effectiveness for N/T Protein Control PY

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

Manufacturer
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 20, 1996

2. Device Name/ Classification:
N/T Protein Control PY: Quality Control Material (assayed)
Classification Number: Class I (862.1660)

3. Identification of the legally marketed device:
Behring Diagnostic Inc., Control Plasma N

4. Proposed Device Description:
The N/T Protein Control PY is a lyophilized pool of citrate plasma consisting of one level containing the following proteins:

- fibrinogen
- antithrombin III
- prothrombin
- plasminogen
- alpha₁-Antitrypsin
- C1 Inhibitor

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# 5. Proposed Device Intended Use:

N/T Protein Control PY is used for control of accuracy and precision in the quantitative immunochemical determination of alpha₁-Antitrypsin, fibrinogen, antithrombin III, prothrombin, plasminogen, fibronectin*, C₁ Inhibitor with the Behring Nephelometer Systems and with the TurbiTimeSystem.

*not available in the U.S.

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

The N/T Protein Control PY is substantially equivalent in intended use to the Control Plasma N. Both products are in vitro diagnostic reagents intended for use as a quality control material to monitor certain laboratory coagulation and protein procedures. The N/T Protein Control PY like the Control Plasma N is single level protein control from a human blood-based matrix (citrate plasma). Both controls are provided with a lot specific table of values. The N/T Protein Control PY like the Control Plasma N is used for the control of the following parameters; prothrombin, fibrinogen, plasminogen, C₁ Inhibitor and antithrombin III. In addition, the N/T Protein Control PY contains alpha₁-Antitrypsin. See Table I for comparative features and the attached N/T Protein Control PY draft package insert for specific product information.

The Behring Diagnostics N/T Protein Control PY differs from the Behring Control Plasma N in that the N/T Protein Control PY is a control for nephelometric coagulation and protein procedures while the Control Plasma N is a control for opto-mechanical and chromogenic coagulation procedures.

# 7. Proposed Device Performance Characteristics:

## Precision and reproducibility:

Precision studies using multiple vials of the controls were run on the Behring Nephelometer. Ten vials of one lot were tested. Each of the parameters were determined in triplicate with each vial. The %CVs were calculated for each parameter. the %CVs ranged from 1.11 to 2.72%.

## Stability:

Stability was run according to an in-house protocols and the control was found stable for at least 12 months lyophilized and 14 days once reconstituted.

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# Table I

## COMPARATIVE FEATURES

### N/T Protein Control PY vs Control Plasma N

| Feature | Control Plasma N | N/T Protein Control PY |
| --- | --- | --- |
| 1. Human Blood-Based Matrix | Yes
(citrate plasma) | Yes
(citrate plasma) |
| 2. Single Level Control | Yes | Yes |
| 3. Multi-Constituent Control | Yes | Yes |
| 4. Quality Control Product | Yes | Yes |
| 5. Lyophilized | Yes | Yes |
| 6. Table of Values Provided | Yes | Yes |
| 7. Coagulation Control | Yes | Yes |