(179 days)
The 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.
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.
Here's a breakdown of the acceptance criteria and study information for the DiaSorin ETI-MAX 3000™ Automated Laboratory Analyzer, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the DiaSorin ETI-MAX 3000™ are implicitly defined by the demonstration of equivalent performance to manual methods for various analytical parameters of previously cleared immunology assays. The performance metrics reported are specific to analytical sensitivity, linearity, reproducibility/precision, carry-over, and method comparison/correlation.
| Acceptance Criteria Category | Specific Acceptance Criterion (Implied by Study Design) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity | To be determined according to NCCLS guideline EP-17A, indicating that the device should be able to determine limits of detection and quantitation comparable to the manual method. | Analytical sensitivity was determined for the manual assays on the ETI-MAX 3000™ by following NCCLS guideline EP-17A. (Specific values are not provided, but the method was followed, implying acceptable determination.) |
| Linearity | Interpretations (positive, equivocal, or negative) should be within +/- 1 dilution from the interpretations for the same dilutions using the manual method across the full assay range. | The ETI-MAX 3000™ interpretations (positive, equivocal or negative) were within +/- 1 dilution from the interpretations for the same dilutions using the manual method, across the full assay range for each product. |
| Reproducibility/Precision | Within-run, between-run, total, and instrument-to-instrument %CVs (Coefficient of Variation) should be within acceptable limits as demonstrated through a multi-site study using coded samples with known characteristics, particularly for samples near the cut-off. (Specific numeric thresholds are not explicitly stated, but the tables provide the observed values, which are presumably deemed acceptable for demonstrating equivalence). | ANA Screen: Overall Total %CVs for 8 samples across 3 sites ranged from 2.0% to 50.6%. Instrument to instrument %CVs ranged from 3.2% to 18.6%. Precision for ANA Screen Kit: Overall Total %CVs for 8 samples across 3 sites ranged from 4.2% to 23.4%. Instrument to instrument %CVs ranged from 1.6% to 8.3%. Precision for Anti-SS-A (Ro) (Qualitative): Overall Total %CVs for 8 samples across 3 sites ranged from 4.1% to 43.4%. Instrument to instrument %CVs ranged from 2.5% to 12.2%. (Note: The provided text abruptly ends the Anti-SS-A (Ro) table before all samples are shown, and then a truncated table continues with "..." followed by another "Anti-SS-A (Ro)" section, which seems to combine the quantitative and qualitative data. Assuming the "Table of Precision for Anti-SS-A (Ro)" contains the qualitative data and the last table contains the semi-quantitative agreements.) |
| Carry-over | No detectable carry-over from the pipettor or washer. | Results indicated there was no carry over from the pipettor or washer for all three assays. |
| Method Comparison/Correlation (Qualitative) | High percent agreement (positive, negative, and overall) with the manual assay results, with acceptable 95% exact confidence intervals. | ANA Screen: Positive Agreement: 100.0% (62/62), Negative Agreement: 96.7% (88/91), Overall Agreement: 94.3% (150/159). (Note: The table layout has some issues, but calculated from the raw counts: (62+88+4) / 159 = 154/159 = 96.86% overall agreement, with 62/64 positive agreement and 88/88 negative agreement ignoring equivocal.) ENA Screen: Positive Agreement: 93.7% (59/63), Negative Agreement: 100.0% (92/92), Overall Agreement: 95.6% (151/159). Anti-SS-A (Ro) Qualitative: Positive Agreement: 100.0% (55/55), Negative Agreement: 100.0% (104/104), Overall Agreement: 100.0% (159/159) with corresponding exact 95% CIs. |
| Method Comparison/Correlation (Semi-Quantitative) | High percent agreement (positive, negative, and overall) with the manual assay results, with acceptable 95% exact confidence intervals. | Anti-SS-A (Ro) Semi-Quantitative: Positive Agreement: 100.0% (54/54), Negative Agreement: 99.0% (104/105), Overall Agreement: 99.4% (158/159) with corresponding exact 95% CIs. |
Study Details
-
Sample size used for the test set and the data provenance:
- Reproducibility/Precision: 8 frozen repository serum samples were tested with 4 replicates per run over 5 days, at 3 different sites, using 3 different instruments. This means for each site, per sample, there were 20 individual results (4 reps/day * 5 days). The total number of measurements for precision is (8 samples * 20 measurements/sample * 3 sites) = 480 measurements per assay. The text indicates "N" could be 20 per site per sample.
- Method Comparison/Correlation: 159 retrospective samples per assay were used.
- Data Provenance:
- Precision: The coded panel was prepared at DiaSorin (Stillwater, MN, USA), and testing was conducted at two external US laboratories and at DiaSorin Inc in Stillwater, MN. This indicates US-based data.
- Method Comparison: "Retrospective samples (w/clinical history)" were used. The country of origin is not specified, but given DiaSorin is based in Minnesota, it is likely US-based or at least North American.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for all performance evaluations (linearity, reproducibility, carry-over, and method comparison) was established by the "manual method" of the three FDA previously cleared immunology assays. The study design does not involve human experts establishing ground truth for the samples themselves. Instead, the manual method serves as the reference standard against which the automated device's performance is compared.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This device is an automated laboratory analyzer, and its performance is compared to a manual laboratory method, not interpreted by human readers requiring adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done, as this is an automated analyzer, not an AI-assisted diagnostic tool that relies on human interpretation improving with AI. The comparison is between an automated system and a manual laboratory process.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance study is primarily a standalone evaluation of the DiaSorin ETI-MAX 3000™ automated system compared to manual methods. There is no human-in-the-loop aspect described; the device performs the assay steps and provides quantitative/qualitative results directly.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used for comparison was the results obtained from the manual method of the FDA-previously cleared immunology assays. This acts as the "reference standard" for evaluating the automated system. The samples themselves were "frozen repository serum samples" or "retrospective samples (w/clinical history)."
-
The sample size for the training set:
- The document does not describe a "training set" in the context of machine learning or AI. This device is an automated instrument, not a learning algorithm. Its operation is based on pre-programmed protocols for known assays, not trained data.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of machine learning/AI for this device. The device's functionality is based on its mechanical and software design to execute laboratory protocols.
{0}------------------------------------------------
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 (651) 351-5850 Fax (651) 351-5669 Email: carol.depouw@diasorin.com
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-LABMago™ 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
{1}------------------------------------------------
(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:
{2}------------------------------------------------
f
| ID# | Site | N | mean(S/CO) | withinrun%CV | betweenrun%CV | total%CV | instrument toinstrument%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 |
{3}------------------------------------------------
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| mean | withinrun | betweenrun | total | instrument toinstrument | |||
|---|---|---|---|---|---|---|---|
| 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 |
| 10.00 | confidence interva' | |
|---|---|---|
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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 |
{4}------------------------------------------------
| 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)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.
{5}------------------------------------------------
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.
{6}------------------------------------------------
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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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
{7}------------------------------------------------
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
Page 1 of 1
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
51003 K052774
§ 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.