← Product Code [GKP](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP) · K962664 # ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER (K962664) _Medical Laboratory Automation Systems, Inc. · GKP · Sep 10, 1996 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K962664 ## Device Facts - **Applicant:** Medical Laboratory Automation Systems, Inc. - **Product Code:** [GKP](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP.md) - **Decision Date:** Sep 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5400 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The ELECTRA 1800C is an in vitro diagnostic instrument which may be categorized as an automatic coagulation timer and photometric analyzer, for the performance of both coagulation and chromogenic testing. Coagulation testing capabilities of the proposed product include routine clotting tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), factor assays, fibrinogen, and thrombin time. Chromogenic testing capabilities include tests such as Antithrombin III. ## Device Story Automated coagulation analyzer; performs coagulation and chromogenic assays (PT, APTT, factor assays, fibrinogen, thrombin time, Antithrombin III). Input: patient blood samples in closed tubes. Operation: photometric analysis; automated sampling mechanism allows closed-tube sampling to reduce biohazard exposure. Output: quantitative coagulation/chromogenic test results. Used in clinical laboratories by trained personnel. Results assist clinicians in assessing patient coagulation status. ## Clinical Evidence No clinical data provided; substantial equivalence based on design and technological comparison to predicate device. ## Technological Characteristics Automated coagulation timer and photometric analyzer. Features closed-tube sampling mechanism. System technology identical to predicate ELECTRA 1600C. ## Regulatory Identification A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies. ## Special Controls *Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument 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 - ELECTRA 1600C™ Automatic Coagulation Timer ([K931206](/device/K931206.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} MLA K962664 # 510(k) Summary (21 CFR 807.92) SEP 10 1996 ELECTRA 1800C Automatic Coagulation Analyzer - **Submitter:** Medical Laboratory Automation, Inc. 270 Marble Avenue Pleasantville, New York 10570 - Tel. No.: (914) 747-3020 - Fax No.: (914) 747-0498 - Contact: JoAnn H. Lopez, Official Correspondent - Date Prepared: July 3, 1996 - **Device:** ELECTRA 1800C Automatic Coagulation Analyzer - Common Name: Automated Coagulation Instrument - Classification Name: Coagulation Instrument (as per 21 CFR 864.5400) - **Predicate Device:** ELECTRA 1600C™ Automatic Coagulation Timer (K931206) - **Device Description:** A detailed description of the device, including an explanation of how it functions and the basic scientific concepts, are described in the ELECTRA 1800C Operator’s Manual, Chapter 1 - Getting Started. - **Intended Use:** The ELECTRA 1800C is an in vitro diagnostic instrument which may be categorized as an automatic coagulation timer and photometric analyzer, for the performance of both coagulation and chromogenic testing. Coagulation testing capabilities of the proposed product include routine clotting tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), factor assays, fibrinogen, and thrombin time. Chromogenic testing capabilities include tests such as Antithrombin III. - **Device Comparison:** The proposed product, ELECTRA 1800C, is essentially equivalent in design to the ELECTRA 1600C™ Automatic Coagulation Analyzer. Basic system technology remains unchanged. The sample mechanism has been modified to allow for closed tube sampling. This modification has been included to limit operator exposure to bloodborne pathogens by eliminating standard practices such as removing tube stoppers for instrument sampling. --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K962664](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKP/K962664) **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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