BEHRING COAGULATION TIMER

K955278 · Behring Diagnostics, Inc. · GGN · May 30, 1996 · Hematology

Device Facts

• Record ID: K955278
• Device Name: BEHRING COAGULATION TIMER
• Applicant: Behring Diagnostics, Inc.
• Product Code: GGN · Hematology
• Decision Date: May 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

Behring Coagulation Timer is a photometric coagulation analyzer intended for clinical use to perform all coagulometric, chromogenic and immunologic coagulation tests.

Device Story

Behring Coagulation Timer (BCT) is a fully automatic photo-optical coagulation analyzer for clinical laboratory use. Device accepts patient samples for coagulation, fibrinolysis, and inhibitor testing. Principle of operation involves photometric detection of clotting (fibrin clot), chromogenic (color development), and immunologic (latex-enhanced) reactions. BCT features integrated barcode scanner for sample identification and Autostart functionality. System operates in random access mode, providing rapid quantitative measurements. Healthcare providers use results to assess patient hemostatic function and monitor coagulation status. Benefits include automated, high-throughput testing with continuous access, improving laboratory efficiency and diagnostic turnaround for coagulation disorders.

Clinical Evidence

Bench testing only. Performance compared against BFA (clotting assays) and Behring Chromotime System (chromogenic assays). Correlation studies: Thromborel S (n=83, r=0.997), Pathromtin (n=83, r=0.99), Berichrom Plasminogen (n=58, r=0.96), Berichrom Protein C (n=74, r=0.99). Precision evaluated over 5 days (n=40 per assay); intra-assay CVs ranged 0.50-3.96%, inter-assay CVs ranged 1.75-6.36%.

Technological Characteristics

Fully automatic photo-optical coagulation analyzer. Sensing principle: Photometric detection (clotting, chromogenic, immunologic). Features: Integrated barcode scanner, random access sample processing, continuous access operation. Connectivity: Standalone laboratory instrument.

Indications for Use

Indicated for clinical use to perform coagulometric, chromogenic, and immunologic coagulation tests for the measurement of coagulation, fibrinolysis factors, inhibitors, and overall homeostatic system function.

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 Fibrintimer A (K926551)

Reference Devices

• Behring Chromotime System (K901829)

Submission Summary (Full Text)

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K955278

# Attachment 1

# 510(k) Summary of Safety and Effectiveness for Behring Coagulation Timer

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: November 16, 1995

2. Device Name/ Classification:

Behring Coagulation Timer: multipurpose system for in vitro coagulation studies
Classification Number: class II (864.5425)

3. Identification of the legally marketed device:

Behring Fibrintimer A

4. Proposed Device Description:

Behring Coagulation Timer (BCT) is a fully automatic photo-optical coagulation instrument. The BCT is used in conjunction with the Behringwerke AG test kits for measurement of coagulation, fibrinolysis factors and inhibitors as well as to measure the function of the homeostatic system as a whole.

5. Proposed Device Intended Use:

Behring Coagulation Timer is a photometric coagulation analyzer intended for clinical use to perform all coagulometric, chromogenic and immunologic coagulation tests.

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

The Behring Coagulation Timer (BCT) is substantially equivalent in intended use and results obtained to the Behring Fibrintimer A (BFA) which was the subject of 510(k) K926551. The BCT like the BFA performs fully automatic, rapid quantitative measurement of coagulation time by optical detection. Both analyzers use photometric technology and offer continuous access operation. Both the BCT and the BFA process samples in the Random Access mode.

The BCT differs from the BFA in that the BCT can provide an Autostart with barcoded samples along with an integrated barcode scanner.

The BCT also differs from the BFA in that the BCT performs three basic types of assays clotting (fibrin clot), chromogenic (color development), and Immunologic (antibodies + latex) whereas the BFA can perform only clotting assays.

7. Proposed Device Performance Characteristics:

Correlation:

Performance characteristics of the Behring Coagulation System and the Behring Fibrintimer A were compared by evaluating several representative assays. The two clotting assays evaluated were Thromborel S and Pathromtin. For Thromborel S, 83 samples were evaluated on the BCT vs. the BFA. A correlation coefficient of 0.997 with a y-intercept of 0.72 and a slope of 0.97.

For Pathromtin, 83 samples were evaluated on the BCT vs the BFA. A correlation coefficient of 0.99 was obtained, with a y-intercept of -0.87 and a slope of 1.0.

The two colorometric assays which were evaluated were Berichrom Plasminogen and Berichrom Protein C. For the Berichrom Plasminogen, 58 samples were evaluated on the BCT vs the Behring Chromotime System (K901829). A correlation coefficient of 0.96 was obtained, with a y-intercept of 9.9 and a slope of 0.97.

For Berichrom Protein C, 74 samples were evaluated on the BCT vs the Behring Chromotime System. A correlation coefficient of 0.99 was obtained, with a y-intercept of -0.69 and a slope of 1.0.

These studies support the substantial equivalence of the BCT and the BFA.

Precision:

Precision of the BCT was evaluated using the above mentioned representative assays. Each level of control was run in replicates of 8 for five days, to total n=40. Intra-assay precision was calculated from either an n=4 or n=8 precision values over the 5 days. Precision data is summarized in the table below.

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Thromborel S:
3 levels ranging from 11 to 59 secs
BCT
Intra-Assay %CV
0.50 to 0.81
Inter-Assay %CV
2.04 to 6.36

Pathromtin:
3 levels ranging from 37 to 91 sec
BCT
Intra-Assay %CV
1.55 to 2.95
Inter-Assay %CV
1.75 to 2.51

Berichrom Plasminogen:
3 levels ranging from 38.52 to 111.74 % norm
BCT
Intra-Assay %CV
2.85 to 3.61
Inter-Assay %CV
2.19 to 3.95

Berichrom Protein C:
3 levels ranging from 77 to 104 % norm
BCT
Intra-Assay %CV
3.33 to 3.96
Inter-Assay %CV
1.90 to 2.54