# K043031: Serim Dialysate Monitor Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: Jun 13, 2005 after 222 days
- Product code: NTZ (Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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 K992431 (1999). 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)
- K945491: Serim (TM) Bicarb PH Reagent Strips, Serim Research Corp. (1995) Summary page 2.
- K992257: New Multiples Reagent Strips, Bayer Corp. (1999) Summary page 2.
- K020908: HDM97, Ibp Instruments GmbH (2002) Summary page 2.

## Indications for use
The Serim Tm Dialysate MonitorTM Test Strip provides semi-quantitative indications of pH, bicarbonate, and glucose (which acts as a tracer for the acid concentrate) concentrations in final bicarbonate dialysate solutions. They can be used to monitor the proper preparation of such dialysate solutions. The SerimTm Dialysate Monitor MT Test Strips are to be used to supplement current methods for testing dialysate.

Source page: https://510kreport.com/device/K043031
Methodology: https://510kreport.com/methodology