# K061419: Teco Microalbumin 2-1 Combo Strips

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Jan 26, 2007 after 249 days
- Product code: JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Teco Diagnostics Microalbumin 2-1 combo Strip is designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine. Microalbuminuria, an abnormal elevation of the urinary albumin excretion rate, is many times one of the first signs of renal diseases and renal damage that can lead to renal failure. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. The Teco Microalbumin 2-1 Combo Strips are read by visual comparing color chart. Teco Microalbumin 2-1 Combo Strips are recommended for use in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.

Source page: https://510kreport.com/device/K061419
Methodology: https://510kreport.com/methodology