ETI-MAX 3000

K052794 · DiaSorin, Inc. · JJF · Mar 31, 2006 · Clinical Chemistry

Device Facts

• Record ID: K052794
• Device Name: ETI-MAX 3000
• Applicant: DiaSorin, Inc.
• Product Code: JJF · Clinical Chemistry
• Decision Date: Mar 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2170
• Device Class: Class 1

Intended Use

The ETI-MAX 3000™ is a fully automated EIA microtiter plate analyzer designed to perform the complete sample processing of qualitative and semi-quantitative assays with respect to (sample dilutions, sample and reagent dispensing, incubations, wash processes, plate transports) as well as the photometric measurement and evaluation. The qualitative and semi-quantitative performance of the ETI-MAX 3000™ instrument were assessed using the DiaScreen ELISA kit, the DiaSorin Anti-SS-A(Ro) ELISA kit and the EuroDiagnostica AB ENA Single Well Screen kit.

Device Story

ETI-MAX 3000 is a fully automated microtiter plate laboratory analyzer; performs sample processing including barcode scanning, predilution, pipetting, plate transport, washing, incubation, and photometric measurement. Operated by laboratory personnel in a clinical setting; controlled by Windows PC software. Device automates manual ELISA assay workflows; processes samples to produce qualitative or semi-quantitative results. Output used by clinicians to support diagnostic decision-making for autoimmune conditions. Benefits include increased laboratory efficiency and standardized processing compared to manual methods.

Clinical Evidence

Bench testing only. Performance evaluated by comparing automated ETI-MAX 3000 results to manual methods using 159 retrospective clinical samples for three immunology assays (ANA Screen, ENA Screen, Anti-SS-A). Metrics included analytical sensitivity (NCCLS EP-17A), linearity, and reproducibility (NCCLS EP5-A2). Method comparison showed high agreement (overall 99.4%–100%) with manual methods. No carry-over detected.

Technological Characteristics

Automated microtiter plate analyzer; includes barcode scanner, predilution/pipetting stations, plate transport, wash station, and incubators. Photometric measurement system. Controlled by Windows PC software. No specific material standards or energy types provided.

Indications for Use

Indicated for automated processing and photometric evaluation of qualitative and semi-quantitative EIA microtiter plate assays in a laboratory setting.

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

• Labotech (K922081)
• Mago™ Automated EIA Processor (K973177)

Submission Summary (Full Text)

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MAR 3 1 2006

K 052794

#### 5.0 510(k) SUMMARY

### SUBMITTED BY:

Carol A. DePouw Regulatory Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone [phone] Fax [phone] Email: [e-mail]

NAME OF DEVICE:

| Trade Name: | DiaSorin ETI-MAX 3000™ |
|----------------------------|------------------------------------------------------------------------------------------|
| Common Names/Descriptions: | Automated Laboratory Analyzer |
| Classification Names: | Discrete photometric chemistry analyzer for clinical use |
| Product Code: | JJF |
| PREDICATE DEVICES: | Labotech (K922081) also known as the ETI-LAB<br>Mago™ Automated EIA Processor ( K973177) |

INTENDED USE: The DiaSorin ETI-MAX 3000™ is a fully automated microtiter plate analyzer designed to perform the complete sample processing of qualitative and semi-quantitative assays with respect to (sample dilutions, sample and reagent dispensing, incubations, wash processes, plate transports) as well as the photometric measurement and evaluation. The qualitative and semi-quantitative performance of the ETI-MAX 3000 ™ instrument were assessed using the DiaSorin ANAScreen ELISA kit, the DiaSorin Anti-SS-A (Ro) ELISA kit and the EuroDiagnostica AB ENA Single Well Screen Kit.

DEVICE DESCRIPTION: The ETI- MAX 3000™ is a fully automated, microtiter plate laboratory analyzer performing the complete sample processing (barcode scanner, predilution station, pipetting station, plate transport, wash station, incubators and photometric measurement). The instrument is controlled by the Windows PC software ETI- MAX 3000™. This software allows the user to process the pre-defined assays of DiaSorin.

### PERFORMANCE DATA:

Performance testing of the ETI- MAX 3000™ consisted of running three FDA previously cleared lmmunology assays by manual method as well as on the ETI-MAX 3000™ to evaluate analytical sensitivity, linearity, reproducibility/precision, carry-over, and method comparison/ correlation.

Analytical sensitivity - Analytical sensitivity was determined for the manual assays on the ETI-MAX 3000™ by following NCCLS guideline EP-17A, Protocols for Determination of Limits of Detection and Limits of Quantitation.

Linearity - Linearity was established by testing serial dilutions of four positive sera across the full assay range for each product. The results indicated the ETI-MAX 3000™ interpretations

#### Section 5

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(positive, equivocal or negative) were within +/- 1 dilution from the interpretations for the same dilutions using the manual method.

Reproducibility/Precision for semi-quantitive and/or qualitative samples - The instrument reproducibility/precision study was conducted at two external US laboratories and at DiaSorin Inc in Stillwater MN. A coded panel comprised of 8 frozen repository serum samples was prepared at DiaSorin and provided to each site for testing by the DiaSorin ETI-MAX 3000™ instrument and the three autoimmune assays. The panel contained 6 samples near the cut-off. Each site ran the coded samples using 4 replicates per run in 1 run per day over 5 days of operation (NCCLS: EP5-A2). Three different instruments were used. The results are summarized in the tables below as sample overall mean S/CO, %CVs computed for within run, between run, total, and instrument to instrument.

| | | | mean | within | between | total | instrument to |
|-----|------|----|--------|--------|---------|-------|---------------|
| | | | | %run | run | | instrument |
| ID# | Site | N | (S/CO) | %CV | %CV | %CV | %CV |
| #1 | 1 | 20 | 0.98 | 6.6 | 0 | 6.3 | |
| | 2 | 20 | 0.86 | 8.5 | 25.7 | 27.1 | 6.8 |
| | 3 | 20 | 0.93 | 20.6 | 0 | 20.4 | |
| #2 | 1 | 20 | 1.05 | 3.1 | 2.6 | 4.0 | |
| | 2 | 20 | 1.12 | 1.9 | 1.1 | 2.2 | 3.2 |
| | 2 | 20 | 1.09 | 2.0 | 0.5 | 2.0 | |
| #3 | 1 | 20 | 0.73 | 4.0 | 2.6 | 4.8 | |
| | 2 | 20 | 0.51 | 4.2 | 50.4 | 50.6 | 18.6 |
| | 3 | 20 | 0.71 | 4.3 | 3.2 | 5.4 | |
| #4 | 1 | 20 | 1.21 | 2.3 | 3.3 | 4.1 | |
| | 2 | 20 | 1.29 | 1.5 | 3.3 | 3.6 | 3.1 |
| | 3 | 20 | 1.25 | 4.3 | 0 | 4.2 | |
| #5 | 1 | 20 | 1.17 | 4.0 | 2.6 | 4.8 | |
| | 2 | 20 | 1.22 | 2.4 | 4.0 | 4.6 | 2.7 |
| | 3 | 20 | 1.23 | 2.7 | 2.0 | 3.4 | |
| #6 | 1 | 20 | 1.26 | 3.0 | 3.0 | 4.3 | |
| | 2 | 20 | 1.08 | 10.9 | 36.4 | 37.9 | 8.4 |
| | 3 | 19 | 1.23 | 22.0 | 0 | 21.8 | |
| #7 | 1 | 20 | 1.33 | 2.0 | 3.6 | 4.2 | |
| | 2 | 20 | 1.34 | 2.7 | 7.0 | 7.5 | 2.8 |
| | 3 | 20 | 1.40 | 3.0 | 0 | 2.9 | |
| #8 | 1 | 20 | 1.29 | 3.0 | 0.3 | 3.0 | |
| | 2 | 20 | 1.28 | 2.2 | 16.0 | 16.1 | 3.2 |
| | 3 | 20 | 1.36 | 2.9 | 4.2 | 5.1 | |

#### Table of Precision for ANA Screen:

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f

| ID# | Site | N | mean<br>(S/CO) | within<br>run<br>%CV | between<br>run<br>%CV | total<br>%CV | instrument to<br>instrument<br>%CV |
|-----|------|----|----------------|----------------------|-----------------------|--------------|------------------------------------|
| #1 | 1 | 20 | 0.52 | 7.1 | 5.1 | 8.7 | |
| | 2 | 20 | 0.48 | 3.0 | 8.9 | 9.4 | 4.5 |
| | 3 | 20 | 0.50 | 6.0 | 5.7 | 8.3 | |
| #2 | 1 | 20 | 1.61 | 4.5 | 4.3 | 6.2 | |
| | 2 | 20 | 1.82 | 3.5 | 2.4 | 4.2 | 6.2 |
| | 3 | 20 | 1.70 | 2.8 | 4.4 | 5.2 | |
| #3 | 1 | 20 | 1.60 | 3.4 | 6.4 | 7.3 | |
| | 2 | 20 | 1.63 | 6.8 | 5.9 | 8.9 | 1.6 |
| | 3 | 20 | 1.66 | 4.0 | 3.0 | 5.0 | |
| #4 | 1 | 20 | 1.81 | 5.3 | 7.5 | 9.1 | |
| | 2 | 20 | 1.76 | 5.3 | 19.6 | 20.3 | 3.0 |
| | 3 | 20 | 1.87 | 2.8 | 4.2 | 5.0 | |
| #5 | 1 | 20 | 1.25 | 5.0 | 4.9 | 7.0 | |
| | 2 | 20 | 1.20 | 10.9 | 20.8 | 23.4 | 3.1 |
| | 3 | 20 | 1.27 | 5.4 | 3.2 | 6.3 | |
| #6 | 1 | 20 | 1.45 | 4.2 | 3.7 | 5.6 | |
| | 2 | 20 | 1.51 | 6.0 | 8.8 | 10.7 | 2.0 |
| | 3 | 20 | 1.50 | 4.4 | 4.6 | 6.3 | |
| #7 | 1 | 20 | 1.30 | 3.2 | 2.9 | 4.3 | |
| | 2 | 20 | 1.50 | 13.7 | 10.2 | 17.1 | 8.3 |
| | 3 | 20 | 1.30 | 9.9 | 5.1 | 11.1 | |
| #8 | 1 | 20 | 1.47 | 5.8 | 3.9 | 7.0 | |
| | 2 | 20 | 1.59 | 7.9 | 10.2 | 12.9 | 5.0 |
| | 3 | 20 | 1.45 | 3.4 | 6.5 | 7.4 | |

# Table of Precision for Anti-SS-A (Ro):

| | | | mean | within | between | total | instrument to |
|-----|------|----|--------|--------|---------|-------|---------------|
| | | | | run | run | | instrument |
| ID# | Site | N | (S/CO) | %CV | %CV | %CV | %CV |
| #1 | 1 | 20 | 0.81 | 4.2 | 6.1 | 7.4 | |
| | 2 | 20 | 0.80 | 8.1 | 5.9 | 10.0 | 3.7 |
| | 3 | 20 | 0.86 | 7.1 | 0 | 7.1 | |
| #2 | 1 | 20 | 0.93 | 3.1 | 4.8 | 5.7 | |
| | 2 | 20 | 0.88 | 4.7 | 2.8 | 5.5 | 2.9 |
| | 3 | 20 | 0.91 | 2.6 | 3.1 | 4.1 | |
| #3 | 1 | 20 | 1.00 | 3.1 | 5.0 | 5.9 | |
| | 2 | 20 | 0.84 | 8.4 | 42.6 | 43.4 | 12.1 |
| | 3 | 20 | 1.07 | 5.1 | 0 | 4.9 | |
| #4 | 1 | 20 | 1.00 | 4.3 | 3.0 | 5.2 | |
| | 2 | 20 | 0.80 | 4.8 | 42.0 | 42.3 | 12.2 |
| | 3 | 20 | 1.00 | 3.6 | 4.7 | 5.9 | |
| #5 | 1 | 20 | 0.99 | 4.3 | 3.7 | 5.6 | |
| | 2 | 20 | 1.04 | 4.3 | 2.7 | 5.1 | 4.7 |
| | 3 | 20 | 1.08 | 7.0 | 7.7 | 10.4 | |
| #6 | 1 | 20 | 1.01 | 3.4 | 3.9 | 5.2 | |
| | 2 | 20 | 0.99 | 3.7 | 3.8 | 5.3 | 2.5 |
| | 3 | 20 | 1.04 | 3.8 | 2.6 | 4.6 | |
| #7 | 1 | 20 | 1.10 | 4.2 | 3.7 | 5.5 | |

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| | | | mean | within<br>run | between<br>run | total | instrument to<br>instrument |
|-----|------|----|--------|---------------|----------------|-------|-----------------------------|
| ID# | Site | N | (S/CO) | %CV | %CV | %CV | %CV |
| | 2 | 20 | 1.05 | 12.7 | 6.5 | 14.3 | 8.3 |
| | 3 | 20 | 1.23 | 6.6 | 3.9 | 7.6 | |
| #8 | 1 | 20 | 1.00 | 3.9 | 3.4 | 5.2 | |
| | 2 | 20 | 1.03 | 4.3 | 1.4 | 4.5 | 4.7 |
| | 3 | 20 | 1.09 | 4.6 | 7.4 | 8.7 | |

Carry-over studies - Testing was conducted for all three assays and results indicated there was no carry over from the pipettor or washer.

Method Comparison/(Correlation) - The automated instrument results were compared to manual method results for all three assays using 159 retrospective samples (w/clinical history). The results are summarized below as positive, negative, and overall percent agreement with the Manual assay results with 95% exact confidence intervals.

| ANA Screen | Manual Method | | | |
|------------------------------|---------------|----------|-----------|-------|
| ETI-Max | Positive | Negative | Equivocal | Total |
| Positive ≥1.0 S/CO | 62 | 0 | 0 | 62 |
| Negative <0.7 S/CO | 0 | 88 | 3 | 91 |
| Equivocal ≥0.7 and <1.0 S/CO | 2 | 0 | 4 | 6 |
| Total | 64 | 88 | 7 | 159 |

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| ENA Screen | Manual Method | | | |
|-------------------------------|---------------|----------|-----------|-------|
| ETI-Max | Positive | Negative | Equivocal | Total |
| Positive >1.0 S/CO | 59 | 0 | 0 | 59 |
| Negative <0.95 S/CO | 4 | 92 | 4 | 100 |
| Equivocal ≥0.95 and ≤1.0 S/CO | 0 | 0 | 0 | 0 |
| Total | 63 | 92 | 4 | 159 |

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| Anti-SS-A (Ro) Qualitative | Manual Method | | | |
|-------------------------------|---------------|----------|-----------|-------|
| ETI-Max | Positive | Negative | Equivocal | Total |
| Positive >1.0 S/CO | 55 | 0 | 0 | 55 |
| Negative <0.95 S/CO | 0 | 104 | 0 | 104 |
| Equivocal ≥0.95 and ≤1.0 S/CO | 0 | 0 | 0 | 0 |
| Total | 55 | 104 | 0 | 159 |

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| | Percent Agreement | Exact 95% confidence interval |
|----------|-------------------|-------------------------------|
| Positive | 100.0% (55/55) | 93.5 – 100.0% |
| Negative | 100.0% (104/104) | 96.5 – 100.0% |
| Overall | 100.0% (159/159) | 97.7 – 100.0% |

| Anti-SS-A (Ro)<br>Semi-Quantitative | Manual Method | | |
|-------------------------------------|---------------|----------|-------|
| ETI-Max | Positive | Negative | Total |
| Positive >2.0 U/mL | 54 | 1 | 55 |
| Negative ≤2.0 U/mL | 0 | 104 | 104 |
| Total | 54 | 105 | 159 |

| | Percent Agreement | Exact 95% confidence interval |
|----------|-------------------|-------------------------------|
| Positive | 100.0% (54/54) | 93.4 - 100.0% |
| Negative | 99.0% (104/105) | 94.8 - 100.0% |
| Overall | 99.4% (158/159) | 96.6 - 100.0% |

#### CONCLUSION:

The ETI-MAX 3000™ Automated Laboratory Analyzer showed equivalent performance to the correspondent manual assay methods for the FDA previously cleared assays. The results demonstrated that ETI-MAX 3000™ Automated Laboratory Analyzer can be used to automate the manual assays effectively.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the three branches of government. The logo is surrounded by the words "U.S. Department of Health and Human Services" in a circular pattern.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 3 1 2006

DiaSorin, Inc. c/o Ms. Carol A. DePouw Regulatory Affairs Specialist 1951 Northwestern Ave P.O. Box 285 Stillwater, MN 55082-0285

Re: k052794

Trade/Device Name: ETI-MAX 3000тм Regulation Number: 21 CFR 862.2170 Regulation Name: Micro Chemistry Analyzer for Clinical Use Regulatory Class: Class I Product Code: JJF Dated: September 29, 2005 Received: October 7, 2005

Dear Ms. DePouw:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 –

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert H. Beckerh

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K052794

Device Name: ETI-MAX 3000™

Indications For Use:

The ETI-MAX 3000™ is a fully automated EIA microtiter plate analyzer designed to perform the complete sample processing of qualitative and semi-quantitative assays with respect to (sample dilutions, sample and reagent dispensing, incubations, wash processes, plate transports) as well as the photometric measurement and evaluation. The qualitative and semi-quantitative performance of the ETI-MAX 3000™ instrument were assessed using the DiaScreen ELISA kit, the DiaSorin Anti-SS-A(Ro) ELISA kit and the EuroDiagnostica AB ENA Single Well Screen kit.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE: BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mana Chan

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**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

51003 K052774