510(k) · Cleared
ClearedEti-Max 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · JJF Analyzer, Chemistry, Micro, For Clinical Use
Cleared on Mar 31, 2006 as substantially equivalent to K922081 (Innovative Medical Systems, Inc., 1992) and 1 other predicate after a 179-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Mar 31, 2006
- Review
- 179 days
- Class
- Class I
- Product code
- JJF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922081 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK922081 Labotech Automated Microtiter AnalyzerInnovative Medical Systems, Inc. · 1992
- This deviceK052794 Eti-Max 3000DiaSorin, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922081 | Labotech Automated Microtiter Analyzer | Innovative Medical Systems, Inc. | 1992 | — |
| 0 (this device) | K052794 | Eti-Max 3000 | DiaSorin, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K922081 | Labotech Automated Microtiter AnalyzerSummary page 1…iscrete photometric chemistry analyzer for clinical use Product Code: JJF PREDICATE DEVICES: Labotech (K922081) also known as the ETI-LAB Mago TM Automated EIA Processor ( K973177) INTENDED… | 1992 |
| * | K973177 | Mago Automated Eia ProcessorSummary page 1…TE DEVICES: Labotech (K922081) also known as the ETI-LAB Mago TM Automated EIA Processor ( K973177) INTENDED USE: The DiaSorin ETI-MAX 3000 TM is a fully automated microtiter plate analyzer designed to perform the complete sam… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All JJF devicesJJF Analyzer, Chemistry, Micro, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJF
FDA has decided no JJF device since 2007.
Median 510(k) review, days · JJF
Too few JJF 510(k)s in any year since 2007 to give a median.
Recalls per year · JJF
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJF
2in 2025
MAUDE reports naming product code JJF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 10 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 21 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 3 | 8 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 2 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ETI-MAX 3000TM 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 3000TM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052794: Eti-Max 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052794
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026