(147 days)
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No
The description focuses on standard software functions for managing laboratory workflows, data, and equipment control, with no mention of AI or ML techniques for data analysis or decision-making.
No medical information or advice is provided here.
No
The device is a software tool for assay and request management, designed to support in vitro diagnostic assay runs and generate reports. It does not treat or diagnose directly, but rather aids in the management and processing of diagnostic data.
No
The device is a software tool for assay management and request management designed to support in vitro diagnostic assay runs and manage diagnostic equipment. It is not a diagnostic device itself, but rather a tool to manage and process data from diagnostic equipment.
Yes
The device is described as a "software tool" and its functions are entirely software-based, managing data, creating lists, evaluating results, and generating reports. While it interacts with hardware (Pharmacia CAP System diagnostic equipment), the device itself is the software component.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement of Intended Use: The "Intended Use / Indications for Use" section clearly states that 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 also mentions being used with "Pharmacia CAP System diagnostic equipment and related devices."
- Functions Directly Related to IVD Assays: The software performs functions essential to running and interpreting in vitro diagnostic tests, such as:
- Handling sample lists and creating worklists for diagnostic equipment.
- Evaluating and calculating assay results.
- Generating laboratory reports.
- Interacting with diagnostic equipment (UniCAP 100) to transfer data and results.
- Used in a Laboratory Setting: The "Intended User / Care Setting" specifies "laboratories running in vitro diagnostic assays."
- Predicate Device is IVD Software: The "Predicate Device(s)" lists "MasterCAP AM Version 1.12 UniCAP 100 RM Software," which is also software used in conjunction with diagnostic equipment for in vitro assays.
While MasterCAP RM 5.0 is a companion software for request management and data storage, its purpose is to support the workflow of running IVD assays managed by MasterCAP AM 5.0. Therefore, the overall system, including both software components, is designed for and used in the context of in vitro diagnostics.
N/A
Intended Use / 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, requester information and test panels, and also provides backup and restore functions.
Product codes (comma separated list FDA assigned to the subject device)
JQW
Device Description
- 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
-
- create an assay run
-
- distribute samples and tests
-
- process an assay
-
- collect raw data
-
- evaluate and calculate the results
-
- export the results to the main frame computer
-
- 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:
-
- create sample lists
-
- store requests, requester information and test panels
-
- create laboratory, result and patient test reports
-
- perform database queries
-
- provide backup and restore functions
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS 10.
This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 (SMDA 1990).
JUN 30 1997
| Date of Summary Preparation: | January 15, 1997 |
|---|---|
| Distributor: | Pharmacia & Upjohn |
| Manufacturer: | Pharmacia & Upjohn AB |
| S-751 82 Uppsala, Sweden | |
| Company Contact Person: | Shelley A. Beadle |
| Pharmacia & Upjohn | |
| Director, Regulatory Affairs | |
| 9200-298-109 | |
| 7000 Portage Road | |
| Kalamazoo, MI 49001-0199 | |
| Device Names: | MasterCAP AM 5.0 |
| MasterCAP RM 5.0 | |
| Common Name: | Software programs for assay and request |
| management designed to support the set | |
| of in vitro diagnostic assay runs with | |
| Pharmacia CAP System diagnostic | |
| equipment, which includes pipetting and | |
| diluting systems for clinical use. |
Classification:
Note: MasterCAP AM and MasterCAP RM are software programs which support the functions of diagnostic equipment classified as "JQW Pipetting and Diluting System for Clinical Use".
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| MasterCAP AM 5.0 | JQW | I | 862.2750 |
| MasterCAP RM 5.0 | JQW | I | 862.2750 |
01-00210
ﻬ
set up
1
Substantial Equivalence to:
MasterCAP AM Version 1.12 UniCAP 100 RM Software
Intended Use Statements:
- 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, requester information and test panels, and also provides backup and restore functions.
mcsec10.doc 1/29/97
01-00211
2
General Description:
- 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
-
- create an assay run
-
- distribute samples and tests
-
- process an assay
-
- collect raw data
-
- evaluate and calculate the results
-
- export the results to the main frame computer
-
- define assay methods and method groups
01-00212
3
- 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:
-
- create sample lists
-
- store requests, requester information and test panels
-
- create laboratory, result and patient test reports
-
- perform database queries
-
- provide backup and restore functions
Device Comparison:
Pharmacia CAP System is a complete modular system for in vitro diagnostics of allergy and other clinical areas. The system is based on ImmunoCAP technology and includes reagents, information and assay management software and automated processing equipment.
MasterCAP AM 5.0 and MasterCAP RM 5.0 are updates of previous versions of information management software designed to support the set up and management of in vitro diagnostic assays using Pharmacia CAP System and related diagnostic equipment.
MasterCAP AM 5.0 is substantially equivalent to MasterCAP AM 1.12, and MasterCAP RM 5.0 is substantially equivalent to UniCAP 100 RM software. Several improvements have been made to the updated software resulting in more convenient and versatile software.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 30 1997
Karen E. Matis Requlatory Affairs Manager Pharmacia & Upjohn- -- ---------5094 St. Andrew Drive Westerville, Ohio 43082
Re : K970420 MasterCAP AM 5.0/MasterCAP RM 5.0 Requlatory Class: II Product Code: JQW Dated: June 6, 1997 Received: June 9, 1997
Dear Ms. Matis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations .
5
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as . described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
MasterCAP AM/RM 5.0 510(k) Submission Section 1. Intended Use Statements
| 510(k) Number : | 6970420 |
|---|---|
| Device Name: | MasterCAP AM 5.0 |
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia A. Bernhardt (for own)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 6970420
Prescription Use
(Per 21 CFR 801.109)
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
mcsec1.doc 1/21/97
(Optional Format 1-2-96)
01-00001
7
MasterCAP AM/RM 5.0 510(k) Submission Section 1. Intended Use Statements
510(k) Number: 6970420
Device Name:
Indications For Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 5910420 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
Optional Format 1-2-96)
。
Image /page/7/Picture/9 description: The image shows the number "01-0002" in a clear, sans-serif font. The numbers and hyphen are uniformly sized and spaced, creating a balanced visual appearance. The digits are printed in black against a white background, providing high contrast and readability.