(147 days)
MasterCAP AM 5.0 is a software tool for Assay Management designed to support the set up of an in vitro diagnostic assay run. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x, or Windows '95 Environment.
MasterCAP AM 5.0 handles sample lists, and creates worklists for the related Pharmacia & Upjohn diagnostic equipment. MasterCAP AM 5.0 also evaluates and calculates the assay results and generates laboratory reports. It can import and export results to main frame computers.
MasterCAP AM 5.0 includes a driver function which can send and receive patient data from UniCAP 100 diagnostic equipment.
MasterCAP RM 5,0 is a software tool for Request Management designed to be used together with MasterCAP AM 5.0. MasterCAP RM 5.0 includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP RM can store requests, requestor information and test panels, and also provides backup and restore functions.
- MasterCAP AM 5.0 is a software tool for assay management designed to support the set up of an in vitro diagnostic immunoassay. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x or Windows '95 Environment. The following Pharmacia CAP System diagnostic equipment and related devices may be used with MasterCAP AM: AutoCAP, Positioning Guide 96, RoboCAP Version 2.0, Fluorocount 96, Assay Washer 96, UniCAP 100.
When using the UniCAP 100 Device Driver Function of MasterCAP AM with UniCAP 100, you can transfer sample list data to, and import evaluated assay results from, one or more connected UniCAP 100 devices.
MasterCAP AM 5.0 software directs the diagnostic equipment to perform the following functions:
- import sample lists from a main frame computer or enter the information manually
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- create an assay run
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- distribute samples and tests
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- process an assay
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- collect raw data
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- evaluate and calculate the results
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- export the results to the main frame computer
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- define assay methods and method groups
- MasterCAP RM 5.Q is a software tool for Request Management designed to be used with MasterCAP AM 5.0 for laboratories running in vitro diagnostic assays. MasterCAP RM includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP AM and MasterCAP RM are designed to be used with Pharmacia CAP System and UniCAP 100 diagnostic equipment and related devices.
MasterCAP RM can perform the following functions:
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- create sample lists
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- store requests, requester information and test panels
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- create laboratory, result and patient test reports
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- perform database queries
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- provide backup and restore functions
The provided document is a 510(k) summary for the MasterCAP AM 5.0 and MasterCAP RM 5.0 software programs. It primarily focuses on demonstrating substantial equivalence to previously marketed devices and describes the intended use and general features of the software for managing in vitro diagnostic assay runs and requests.
Unfortunately, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
The document is a regulatory submission for premarket notification, which describes the device and its intended use to the FDA for a determination of substantial equivalence. It does not typically include detailed performance study data such as those requested in your prompt (e.g., specific performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert consensus, etc.).
Therefore, I cannot populate the table or answer the specific questions about performance studies based on the provided text. The document states that "Several improvements have been made to the updated software resulting in more convenient and versatile software," but it does not quantify these improvements or provide data to support specific performance claims beyond functionality.
§ 862.2750 Pipetting and diluting system for clinical use.
(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.