← Product Code [JPA](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA) · K970431 # BEHRING COAGULATION SYSTEM (K970431) _Behring Diagnostics, Inc. · JPA · May 5, 1997 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K970431 ## Device Facts - **Applicant:** Behring Diagnostics, Inc. - **Product Code:** [JPA](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA.md) - **Decision Date:** May 5, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5425 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for 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. ## Regulatory 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](/device/K955278.md)) - Behring Fibrintimer A ([K926551](/device/K926551.md)) ## 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} 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: 408-239-2000 ### 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%. --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K970431](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K970431) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com