MAGO AUTOMATED EIA PROCESSOR

K973177 · Diamedix Corp. · JJF · Oct 9, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973177
• Device Name: MAGO AUTOMATED EIA PROCESSOR
• Applicant: Diamedix Corp.
• Product Code: JJF · Clinical Chemistry
• Decision Date: Oct 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2170
• Device Class: Class 1

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.

Device Story

MAGO Automated EIA Processor performs automated enzyme immunoassay (EIA) procedures in clinical laboratories. Device utilizes automated transport mechanism to position microplates; pipetting station aspirates/dispenses fluids; wash station simulates microplate washing. User-programmable sequences control sample dilution, addition, incubation, and reagent dispensing, mimicking manual assay procedures. System automates labor-intensive steps of EIA, reducing manual intervention. Healthcare providers use processed microplates for diagnostic testing; output facilitates clinical decision-making by providing standardized, automated assay results.

Clinical Evidence

Performance evaluated by comparing MAGO automated processing against standard manual procedures across six separate EIA systems. Results demonstrated that the device functioned as intended with no substantial difference between manual and automated assay performance.

Technological Characteristics

Automated EIA processor featuring a transport mechanism for microplates, a pipetting station for fluid handling, and a wash station. Employs standard pipetting and washing technology. User-programmable control for assay sequences (dilution, addition, incubation, reagent dispensing).

Indications for Use

Indicated for use as a general purpose automated EIA processor in clinical laboratories, specifically moderate complexity laboratories.

Regulatory Classification

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.

Predicate Devices

• Rosys Plato 3300

Submission Summary (Full Text)

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## 510(k) SUMMARY Diamedix's MAGO™ Automated EIA Processor

K973177

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: [phone] Facsimile: [phone]

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: [phone] Facsimile: [phone]

#### 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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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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) | |
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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