# K110035: Indiko

- Pathway: 510(k) (Traditional)
- Applicant: Thermofisher Scientific OY
- Decided: Jun 28, 2011 after 174 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K061107 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061107: DPC T60I Kusti, Model 984248; DPC T60I, Model 984247, Thermo Electron OY (2006) Summary page 2.

## Recalls of this device
- May 13, 2015 · Class II · Z-1018-2017: Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.

## Indications for use
The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (HK) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K110035
Methodology: https://510kreport.com/methodology