# K110520: Biolis 12I

- Pathway: 510(k) (Traditional)
- Applicant: Tokyo Boeki Medisys, Inc.
- Decided: Mar 23, 2012 after 394 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K851172 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042169: Stanbio Laboratory Sirrus Clinical Chemistry Analyzer, Stanbio Laboratory (2005) Summary page 3.
- K040958: Prestige Models 24I and 400 and MGC Model 240, Tokyo Boeki Medical System, Ltd. (2005) Summary page 2.

## Indications for use
The Biolis 12i is a discrete photometric chemistry analyzer with ion-selective electrode (ISE), with direct quantitative measurement of sodium, potassium, chloride, and glucose in serum. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays for clinical use. The Biolis 12i includes an optional Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. The Biolis 12i is not for Point-Of-Care testing: It is for vitro diagnostic use only. Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. The Biolis 12i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic glycemia, and of the pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K110520
Methodology: https://510kreport.com/methodology