(63 days)
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No
The summary describes a standard in vitro diagnostic instrument for coagulation and chromogenic testing, with no mention of AI or ML terms or functionalities.
No.
The device is described as an in vitro diagnostic instrument for performing coagulation and chromogenic testing, which is used for diagnosis, not therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the ELECTRA 1800C is an "in vitro diagnostic instrument." It lists various diagnostic tests it performs, such as prothrombin time (PT) and activated partial thromboplastin time (APTT).
No
The device is described as an "in vitro diagnostic instrument" and an "automatic coagulation timer and photometric analyzer," which are hardware components used for performing laboratory tests. The summary does not indicate that the device is solely software.
Yes, based on the provided information, the ELECTRA 1800C is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states, "The ELECTRA 1800C is an in vitro diagnostic instrument..." This is the most direct confirmation.
- Function: The description of its function as an "automatic coagulation timer and photometric analyzer, for the performance of both coagulation and chromogenic testing" aligns with the typical activities performed by IVD devices, which analyze samples (like blood) outside the body to provide diagnostic information.
- Tests Performed: The list of tests it performs (PT, APTT, factor assays, fibrinogen, thrombin time, Antithrombin III) are all common in vitro diagnostic tests used to assess blood clotting and related conditions.
Therefore, the intended use and the types of tests it performs clearly categorize the ELECTRA 1800C as an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
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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, Chaper 1 - Getting Started.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
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.
0
510(k) Summary (21 CFR 807.92)
SEP 1 0 1996
ELECTRA 1800C Automatic Coagulation Analyzer
Submittor: 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 Analvzer ● 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, Chaper 1 - Getting Started ..
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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 modifed 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.