(45 days)
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.
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.
The provided text describes the Diamedix MAGO™ Automated EIA Processor, a device intended for general-purpose automated EIA processing in moderate complexity laboratories. The submission focuses on establishing substantial equivalence to existing manual methods and predicate devices rather than complex clinical performance studies with detailed acceptance criteria as might be expected for an AI/ML powered diagnostic device.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format typically seen for a new diagnostic assay. Instead, the performance objective was "no substantial difference" between the MAGO and manual methods.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functioned as intended | MAGO functioned as intended |
| No substantial difference between automated and manual methods | Demonstrated no substantial difference between performing the test manually and performing the assay on the MAGO |
2. Sample Size Used for the Test Set and Data Provenance
The text states: "The MAGO was compared to the standard manual procedures in six separate EIA systems."
- Sample Size for Test Set: This phrasing suggests that six separate EIA systems were used for comparison, but it does not specify the number of individual tests, assays, or patient samples run within each of those systems. It implies that the comparison was across different types of EIA systems (e.g., different assays), rather than a specific number of samples within one system.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. The comparison was against "standard manual procedures," implying existing validated manual methods served as the reference, but no information on expert review or ground truth establishment is given.
4. Adjudication Method for the Test Set
No adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or mentioned. The device is an automated processor, not a diagnostic aid requiring human interpretation of output. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.
6. Standalone Performance Study
Yes, a standalone study was done in the sense that the MAGO's performance was directly compared to manual methods. The purpose was to show that the automated system could replicate the results of the manual methods without human intervention beyond setting up the machine.
7. Type of Ground Truth Used
The "ground truth" was established by standard manual procedures for Enzyme Immunoassay (EIA) systems. This means the results obtained from manually performed EIA tests were considered the reference truth against which the automated MAGO's results were compared.
8. Sample Size for the Training Set
Not applicable. This device is an automated processor, not an AI/ML algorithm that requires a "training set" in the context of machine learning. Its operation is based on programmed protocols simulating manual pipetting, washing, and incubation steps.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the machine learning sense for this device.
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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
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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
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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) | |
|---|---|
| (Division Sign-Off) Division of Clinical Laboratory Devices | |
| 510(k) Number |
WDC - 66240/1 - 0466304.02
§ 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.