# K052794: Eti-Max 3000

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Mar 31, 2006 after 179 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922081 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922081: Labotech Automated Microtiter Analyzer, Innovative Medical Systems, Inc. (1992) Summary page 1.
- K973177: Mago Automated Eia Processor, Diamedix Corp. (1997) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K052794
Methodology: https://510kreport.com/methodology