# K122177: Elitech Clinical Systems Urine Total Protein Plus Standard 100 MG/DL, Elitech Clinical Systems Urine Control BI-Level

- Pathway: 510(k) (Abbreviated)
- Applicant: Elitechgroup
- Decided: Feb 15, 2013 after 207 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K971954 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092570: Abx Pentra Tpu Cal, Model A11A01898, Horiba Abx Sas (2009) Summary page 1.
- K020817: Liquichek Urine Chemistry Control, Bio-Rad Laboratories, Inc. (2002) Summary page 2.

## Indications for use
ELiTech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is intended for the calibration of quantitative ELiTech Clinical Systems URINE TOTAL PROTEIN on ELITech Clinical Systems Selectra Pro Series Analyzers. ELiTech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELiTech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

Source page: https://510kreport.com/device/K122177
Methodology: https://510kreport.com/methodology