← Product Code [GFO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO) · K955450 # PATHROMTIN SL (K955450) _Behring Diagnostics, Inc. · GFO · Apr 19, 1996 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO/K955450 ## Device Facts - **Applicant:** Behring Diagnostics, Inc. - **Product Code:** [GFO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO.md) - **Decision Date:** Apr 19, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.7925 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} attachment 1 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. 000008 {1} 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. 000009 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO/K955450](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFO/K955450) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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