PATHROMTIN SL

K955450 · Behring Diagnostics, Inc. · GFO · Apr 19, 1996 · Hematology

Device Facts

• Record ID: K955450
• Device Name: PATHROMTIN SL
• Applicant: Behring Diagnostics, Inc.
• Product Code: GFO · Hematology
• Decision Date: Apr 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

Intended Use

Pathromtin SL is a reagent for the determination of the activated partial thromboplastin time in human plasma.

Device Story

Pathromtin SL is an in vitro diagnostic reagent used to determine activated partial thromboplastin time (aPTT) in human plasma. The reagent contains vegetable-derived phospholipids and silicon dioxide particles as a surface activator. In clinical laboratory settings, the reagent is added to human plasma samples to activate the intrinsic coagulation system; calcium chloride is subsequently added to complete the coagulation process. The resulting clotting time is measured to evaluate coagulation function. The device is intended for use by laboratory professionals to assist in clinical decision-making regarding patient coagulation status.

Clinical Evidence

Bench testing only. Comparative study of 212 plasma samples between Pathromtin SL and Actin® FS yielded a correlation coefficient of 0.96, slope of 0.99, and y-intercept of 2.1. Precision studies (n=40 over 5 days) showed intra-assay precision of 0.3-2.5 %CV and inter-assay precision of 0.7-3.3 %CV.

Technological Characteristics

Reagent composition: vegetable-derived phospholipids and silicon dioxide particles. Principle: activation of intrinsic coagulation system via surface activator and phospholipids, followed by calcium chloride addition. Form factor: liquid reagent.

Indications for Use

Indicated for the determination of activated partial thromboplastin time (aPTT) in human plasma to assess the intrinsic coagulation system.

Regulatory Classification

Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Predicate Devices

• Dade® Actin® FS Activated PTT Reagent

Submission Summary (Full Text)

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K955450

# 510(k) Summary of Safety and Effectiveness for Pathromtin SL

1. Manufacturer Name, Address, phone number, contact name and date of preparation:

Manufacturer
Behringwerke AG
Postfach 1140
35001 Marburg
Germany

APR 19 1995

Distributor:
Behring Diagnostics Inc.,
151 University Avenue
Westwood, MA 02090
617-320-3153
Contact name: Nancy M Johansen

date of preparation: November 27, 1995

2. Device Name/Classification:
Reagents for use in the determination of activated partial thromboplastin time/Class II (864-7925)

3. Identification of the legally marketed device to which the submitter claims equivalence.
Dade® Actin® FS Activated PTT Reagent

4. Proposed Device Description:
Pathromtin SL is a reagent consisting of a phospholipid (vegetable) and a surface activator (silicon dioxide particles) used to activate the factors of the intrinsic coagulation system.

5. Proposed Device Intended Use:
Pathromtin SL is a reagent for the determination of the activated partial thromboplastin time in human plasma.

6. Medical device to which equivalence is claimed and comparison information:
Pathromtin SL is substantially equivalent in intended use and results obtained to the Actin® FS aPTT reagent. Both assays contain phospholipids (phosphatides) and an activator to initiate the intrinsic coagulation system. Both depend on the addition of calcium chloride to complete the coagulation process.

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7. Proposed Device Performance characteristics:

Correlation:
Results of comparative studies using the Pathromtin SL reagent and the Actin® FS aPTT reagent with 212 plasma samples gave a correlation coefficient of 0.96 and a y-intercept of 2.1, and a slope of 0.99.

Precision:
Precision studies were run over a 5 day period, twice per day, to total n=40. Intra-assay precision was calculated from the n=4 precision values over the 5 days. Intra-assay precision ranges from 0.3-2.5 %CV, while the inter-assay precision ranged from 0.7-3.3 %CV.

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