← Product Code [JPA](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA) · K955720 # AMAX CS-190 COAGULATION ANALYZER SYSTEM (K955720) _Sigma Diagnostics, Inc. · JPA · Mar 13, 1996 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K955720 ## 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:** Mar 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5425 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The Amelung AMAX CS-190 Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX CS-190 Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time(PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX CS-190 Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III). ## Device Story Automated random access multipurpose coagulation analyzer; utilizes mechanical (ball method) or photo-optical principles to detect fibrin formation. Performs clot-based assays (PT, APTT, fibrinogen, factor assays) and chromogenic assays (AT III). Used in clinical laboratory settings by trained personnel. Provides quantitative results for coagulation parameters; assists clinicians in diagnosing and monitoring coagulation disorders. Benefits patients through rapid, automated, and precise coagulation testing. ## Clinical Evidence Bench testing only. Comparison studies performed against TOA CA-5000 (mechanical), BBL Fibrometer, and manual spectrophotometric methods. PT (optical) r=0.989; APTT (optical) r=0.907; Factor IX (optical) r=0.954; Factor X (optical) r=0.980; Fibrinogen (optical) r=0.979; AT III r=0.848. Precision studies showed CV <4% for PT/APTT, <9% for factor assays, <10% for fibrinogen, and <6% for AT III. ## Technological Characteristics Automated random access analyzer; dual-mode detection: mechanical (ball method) and photo-optical. Performs clot-based and chromogenic assays. No specific materials, connectivity, or software architecture details provided. ## 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. ## Reference 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} 510(k) NOTIFICATION Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103 AMAX CS-190 Coagulation Analyzer December 15, 1995 K955720 MAR 13 1996 # ATTACHMENT 1 ## Summary of Safety and Effectiveness {1} 510(k) NOTIFICATION Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103 AMAX CS-190 Coagulation Analyzer December 15, 1995 # ATTACHMENT 1 ## 510(k) Summary of Safety and Effectiveness The Amelung AMAX CS-190 Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX CS-190 Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time(PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX CS-190 Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III). In comparison studies of clot based assays between the AMAX CS-190 Coagulation Analyzer (photo-optical or mechanical) and the TOA Medical Electronics CA-5000 (mechanical), the following regression statistics were obtained: | PT (optical) | r = 0.989 | y = 1.113x - 0.9 | | --- | --- | --- | | APTT (optical) | r = 0.907 | y = 0.848x + 7.3 | | Factor IX (optical) | r = 0.954 | y = 0.950x + 0.7 | | Factor IX (mechanical) | r = 0.882 | y = 0.882x + 2.3 | | Factor X (optical) | r = 0.980 | y = 1.019x + 0.0 | | Factor X (mechanical) | r = 0.976 | y = 1.001x - 0.3 | | Fibrinogen (optical) | r = 0.979 | y = 1.211x + 0.9 | In comparison studies of mechanical clot based assays between the AMAX CS-190 Coagulation Analyzer and the BBL Fibrometer, the following regression statistics were obtained: | PT | r = 0.985 | y = 1.067x - 0.3 | | --- | --- | --- | | APTT | r = 0.885 | y = 1.427x + 0.4 | In comparison studies of chromogenic assays between the AMAX CS-190 Coagulation Analyzer and the manual spectrophotometric method, the following regression statistics were obtained: | AT III | r = 0.848 | y = 0.848x + 5.0 | | --- | --- | --- | The coefficient of variation for precision studies was less than 4% for the PT and APTT assays, less than 9% for the factor assays, less than 10% for the fibrinogen assays, and less than 6% for AT III. The safety and effectiveness of the AMAX CS-190 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/K955720](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K955720) **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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