# K964264: High Range Peroxide Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Biomedical Technology, Inc.
- Decided: Jun 16, 1997 after 234 days
- Product code: FKP (System, Dialysate Delivery, Single Patient)
- 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Renalin Perassay™ 500: named in the summary without a submission number

## Most influential descendants
- K152394: Rapicide PA High-Level Disinfectant Test Strips (2016), 2 descendants of its own
- K251035: DISINTEK™ PA Test Strips (2025), 0 descendants of its own
- K251048: Rapicide PA High-Level Disinfection Test Strip  Model Ref # = ML02-0118 (2025), 0 descendants of its own

## Indications for use
High Range Peroxide™ Test Strip is intended for use as an efficacy test strip for measuring effective levels of peroxide in Renalin® disinfectant solution. Each time when the kidney unit is reprocessed with peroxide disinfectant solution such as Renalin® , the reprocessing solution should be monitored with the High Range Peroxide™ Test Strip to assure that Renalin® concentration is 3% as it is intended to be. After the Iddney is placed under storage until next use, the Renalin® concentration in the disinfectant solution should be checked again before rinsing with the strip to assure that Renalin® concentration has been maintained at 1% or higher. If the Renalin® concentration drops below 1%, the kidney unit has to be either reprocessed or discarded.

Source page: https://510kreport.com/device/K964264
Methodology: https://510kreport.com/methodology