← Product Code [JPA](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA) · K960875 # KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632) (K960875) _Sigma Diagnostics, Inc. · JPA · Sep 10, 1996 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K960875 ## Device Facts - **Applicant:** Sigma Diagnostics, Inc. - **Product Code:** [JPA](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA.md) - **Decision Date:** Sep 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5425 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. ## Device Story Automated random access coagulation analyzer; utilizes mechanical ball method to detect fibrin formation; performs PT, APTT, fibrinogen, and factor assays; used in clinical laboratory settings by trained personnel; provides quantitative clotting test results; assists clinicians in assessing patient coagulation status and managing anticoagulant therapy. ## Clinical Evidence Bench testing only. Comparison studies performed against TOA Medical Electronics CA-5000 and BBL Fibrometer. PT, APTT, Fibrinogen, Factor IX, and Factor X assays evaluated. Regression analysis showed high correlation (r=0.915 to 0.980). Precision studies demonstrated coefficient of variation <5% for PT/APTT, <6% for fibrinogen, and <10% for factor assays. ## Technological Characteristics Automated mechanical coagulation analyzer; utilizes 'ball method' for fibrin detection; random access architecture; designed for clinical laboratory environment. ## 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 - TOA Medical Electronics CA-5000 - BBL Fibrometer ## 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} SEP 10 1996 K960875 510(k) NOTIFICATION Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103 KC 40 Micro Coagulation Analyzer February 27, 1996 # ATTACHMENT 1 ## 510(k) Summary of Safety and Effectiveness The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In comparison studies between the KC 40 and the TOA Medical Electronics CA-5000, the following regression statistics were obtained: | PT | r = 0.980 | y = 1.123x + 0.616 | | --- | --- | --- | | APTT | r = 0.936 | y = 1.101x + 4.570 | | Fibrinogen | r = 0.931 | y = 1.163x - 29.927 | | Factor IX | r = 0.944 | y = 0.964x + 7.937 | | Factor X | r = 0.970 | y = 1.040x - 1.884 | In comparison studies between the KC 40 and the BBL Fibrometer, the following regression statistics were obtained: | PT | r = 0.980 | y = 1.009x + 0.701 | | --- | --- | --- | | APTT | r = 0.915 | y = 1.244x - 0.778 | The coefficient of variation for precision studies was less than 5% for the PT and APTT assays, less than 6% for the fibrinogen assay, and less than 10% for the factor assays. The safety and effectiveness of the KC 40 Micro Coagulation Analyzer is demonstrated by its substantial equivalency to the predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K960875](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K960875) **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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