# K970420: Mastercap AM 5.0/Mastercap RM 5.0

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia, Inc.
- Decided: Jun 30, 1997 after 147 days
- Product code: JQW (Station, Pipetting And Diluting, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MasterCAP AM Version 1.12: named in the summary without a submission number
- (no number) UniCAP 100 RM Software: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K970420
Methodology: https://510kreport.com/methodology