(45 days)
(1) Rosys Plato 3300
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No
The description focuses on automated pipetting, washing, and user-programmed sequences, which are standard features of automated laboratory processors and do not indicate AI/ML. There is no mention of AI, ML, or related terms.
No
The device is an automated general purpose EIA processor used in laboratories for performing diagnostic procedures, not directly treating patients.
No
The device is described as an automated EIA processor that performs general laboratory procedures. It does not analyze or interpret patient data for diagnosis; instead, it automates existing manual assay procedures.
No
The device description explicitly states it provides a "pipetting station" and a "wash station," which are hardware components. It also describes physical actions like "aspirating and dispensing fluids" and "simulating a microplate washing device." While it includes user programming (software), it is integrated with and controls physical hardware.
Based on the provided information, the MAGO device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the MAGO is intended for use as a "general purpose automated EIA processor" and is "indicated for use in moderate complexity laboratories for performing automated EIA procedures" and "for use in clinical laboratories." EIA (Enzyme Immunoassay) procedures are laboratory tests performed on biological samples (like blood, urine, etc.) to detect the presence of specific substances, which is a core function of IVD devices.
- Device Description: The description details how the device performs functions like pipetting, washing, sample dilution, reagent dispensing, and incubation, all of which are steps involved in performing in vitro diagnostic tests.
- Intended User/Care Setting: The intended users are "moderate complexity laboratories" and "clinical laboratories," which are typical settings where IVD testing is performed.
While the document doesn't explicitly use the term "In Vitro Diagnostic" in the intended use, the description of its function and intended use clearly aligns with the definition of an IVD device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The MAGO is intended to be used as a general purpose automated EIA processor. The MAGO is indicated for use in moderate complexity laboratories for performing automated EIA procedures.
The Diamedix MAGO is indicated for use as a general purpose automated EIA processor for use in clinical laboratories.
Product codes (comma separated list FDA assigned to the subject device)
JJF
Device Description
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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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
moderate complexity laboratories
clinical laboratories
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)
The MAGO was compared to the standard manual procedures in six separate EIA systems. In all instances, the MAGO functioned as intended and demonstrated that there was no substantial difference between performing the test manually and performing the assay on the MAGO.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
(1) Rosys Plato 3300
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.
Not Found
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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§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(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
510(k) SUMMARY Diamedix's MAGO™ Automated EIA Processor
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Submitter and Contact Person's Name:
Lynne Stirling, Ph.D. Diamedix Corporation 2140 North Miami Avenue Miami, FL 33127 Phone: (305) 324-2354 Facsimile: (305) 324-2585
Date Prepared: August 21, 1997
Name of Device and Name/Address of Sponsor
Name of Device: MAGO™ Automated EIA Processor
Name and Address of Sponsor:
Lynne Stirling, Ph.D. Diamedix Corporation 2140 North Miami Avenue Miami, FL 33127 Phone: (305) 324-2354 Facsimile: (305) 324-2585
Common or Usual Name
Automated EIA Processor
Classification Name
Pipetting and diluting system for clinical use
Predicate Devices
(1) Rosys Plato 3300
1
Technological Characteristics and Substantial Equivalence
Intended Use:
The MAGO is intended to be used as a general purpose automated EIA processor. The MAGO is indicated for use in moderate complexity laboratories for performing automated EIA procedures.
Principles of Operation:
The MAGO and its predicates all share the same principle of operation. Each device provides a pipetting station which is capable of performing normal pipetting functions such as, accurately aspirating and dispensing fluids into microplates and a wash station capable of simulating a microplate washing device. The device allows user programming which controls the sequence of activity to allow sample dilution and addition, incubation, and reagent dispensing which mimics and duplicates manual assay procedures.
Technical Characteristics:
The MAGO and the predicate processors employ an automatic transport mechanism to bring the individual microplate into position for processing. All the devices employ standard pipetting and washing technology to perform the various processing procedures.
Performance Data:
The MAGO was compared to the standard manual procedures in six separate EIA systems. In all instances, the MAGO functioned as intended and demonstrated that there was no substantial difference between performing the test manually and performing the assay on the MAGO.
Summary of the Basis for the Finding of Substantial Equivalence:
The MAGO is substantially equivalent to the other currently marketed devices and to the manual methods which are referenced above. There is no substantial difference between the MAGO and its predicate devices in performance or technical characteristics. The MAGO has the same intended use, indications for use, and the same principles of operation as the predicate devices. Thus, the MAGO raises no new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest movement and flight. The overall design is simple and clean, with a focus on the eagle as a symbol of the department.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 9 1997
Lynne Stirling, Ph.D. Diamedix Corporation 2140 North Miami Avenue Miami, Florida 33127
K973177 Re : Trade Name: MAGO™ Automated EIA Processor Regulatory Class: II Product Code: JJF August 21, 1997 Dated: Received: Auqust 25, 1997
Dear Dr. Stirling:
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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 Regulations.
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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(K) Number: K973177
Device Name: MAG0
TM Automated EIA Processor
Indications for Use:
The Diamedix MAGO is indicated for use as a general purpose automated EIA processor for use in clinical laboratories.
PLEASE DO NOT WRITE BELOW THIS LINE (CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-the-Counter Use (Optional Format 1-2-96) | |
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| (Division Sign-Off) Division of Clinical Laboratory Devices | |
| 510(k) Number |
WDC - 66240/1 - 0466304.02