# K060215: Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002

- Pathway: 510(k) (Traditional)
- Applicant: Eurotrol B.V.
- Decided: Mar 24, 2006 after 56 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K023928 (2002). 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)
- K023928: Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis Control, Medical Analysis Systems, Inc. (2002) Summary page 1.

## Indications for use
AlbuTrol is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Urine Albumin and HemoCue® Albumin 201 systems.

Source page: https://510kreport.com/device/K060215
Methodology: https://510kreport.com/methodology