# K042322: Sterichek Blood Leak Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Hach Company
- Decided: Dec 7, 2004 after 103 days
- Product code: FJD (Detector, Leak, Blood)
- 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: 3 generations back to K896454 (1990). 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)
- K012115: Serim Blood Leak Test Strip-2, Serim Research Corp. (2001) Summary page 1.
- K990206: Serim Blood Leak Test Strip, Serim Research Corp. (1999) Summary page 1.

## Indications for use
SteriChek® Blood Leak Reagent Strips provide a quick convenient means of checking the presence of Blood in dialysate to assist in confirming an alarm by the blood leak monitor of the Hemodialysis machine.

Source page: https://510kreport.com/device/K042322
Methodology: https://510kreport.com/methodology