BEHRING COAGULATION SYSTEM

K970431 · Behring Diagnostics, Inc. · JPA · May 5, 1997 · Hematology

Device Facts

• Record ID: K970431
• Device Name: BEHRING COAGULATION SYSTEM
• Applicant: Behring Diagnostics, Inc.
• Product Code: JPA · Hematology
• Decision Date: May 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Behring Coagulation System is an instrument intended to perform quantitative assays of specific parameters in plasma.

Device Story

Fully automated coagulation instrument; processes plasma samples using Behring Diagnostics test kits. Performs coagulometric and chromogenic coagulation tests. Used in clinical laboratory settings by trained laboratory personnel. Instrument automates assay execution; provides quantitative results for coagulation parameters. Healthcare providers use output to assess patient coagulation status and guide clinical management of hemostatic disorders.

Clinical Evidence

Bench testing only. Comparative analysis performed against predicate devices (BCT, BFA) using various coagulometric and chromogenic assays; correlation coefficients ranged from 0.97 to 0.996. Precision studies conducted per NCCLS EP5 guidelines; within-run precision 0.5-6.3%, total precision 0.90-8.1%.

Technological Characteristics

Fully automated coagulation analyzer. Utilizes coagulometric and chromogenic detection principles. Designed for in vitro diagnostic use. System operates as a standalone laboratory instrument.

Indications for Use

Indicated for use in clinical laboratories to perform quantitative coagulometric and chromogenic coagulation assays on plasma samples.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies 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

• Behring Coagulation Timer (K955278)
• Behring Fibrintimer A (K926551)

Submission Summary (Full Text)

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K970431
MAY - 5 1997

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
## For Behring Coagulation System

### 1. Manufacturer and Contact Information:

**Manufacturer:** Behring Diagnostics GmbH
P.O. Box 1149
35001 Marburg, Germany

**Contact Information:**
Paul Rogers
Behring Diagnostics Inc.
3403 Yerba Buena Road
P.O. Box 49013
San Jose, CA 95161-9013
Tel: [phone]

### 2. Device Classification Name:

The Behring Coagulation System is a Class II device and is classified as a multipurpose system for *in vitro* coagulation studies (21 CFR §864.5425).

### 3. Intended Use:

The Behring Coagulation System is an instrument intended to perform quantitative assays of specific parameters in plasma.

### 4. Substantial Equivalence:

Behring Diagnostics Inc. considers the BCS to be substantially equivalent to the Behring Coagulation Timer (K955278) and the Behring Fibrintimer A (K926551) in terms of intended use, instrument features, and overall performance characteristics.

### 5. Device Description and Performance Characteristics:

The Behring Coagulation System (BCS) is a fully automated coagulation instrument. The BCS is used in conjunction with Behring Diagnostics test kits to perform various coagulometric and chromogenic coagulation tests.

**Comparative Analysis:** Sample correlation data were collected on the BCS and either the BCT of BFA instruments using various coagulometric and chromogenic assays. Regression analysis on each assay used showed a range of correlation coefficients from 0.97 to 0.996.

**Precision:** Precision studies were performed following the NCCLS EP5 guideline using samples which were in the normal and abnormal ranges of various coagulation assays. The within-run precision ranged from 0.5 to 6.3%. The total precision ranged from 0.90 to 8.1%.