Sterichek(Tm) Residual Peroxide Reagent Strps

• • Terminated Z-2016-2009 FDA Unclassified (pre-2012) ·initiated 21 Apr 2009

  Some of the reagent strip bottles contain the incorrect strips

510(k) Number

K974798 ↗

FDA Product Code

LIF

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Sterichek Peracetic Acid Reagent Strips

  Class II

  FDA 510(k) K980164 Active Cleared 16 Apr 1998

• Sterichek Chlorine Reagent Strips

  Class II

  FDA 510(k) K971598 Active Cleared 18 Jul 1997

• Sterichek Total Chlorine Reagent Strips

  Class II

  FDA 510(k) K001194 Active Cleared 11 Jul 2000

• Sterichek Total Chlorine Test Kit

  Class II

  FDA 510(k) K983997 Active Cleared 2 Apr 1999

• Sterichek Bicarb pH Reagent Strips

  Class II

  FDA 510(k) K031267 Active Cleared 23 Dec 2003

• Sterichek Sensitive-Feed Water and Rinse Water Reagent Strips

  Class II

  FDA 510(k) K003615 Active Cleared 1 Feb 2001

See all devices from Environmental Test Systems, Inc. →

• What is the Sterichek Residual Peroxide Reagent Strips used for in a clinical setting?

  These strips are specifically designed to detect residual peroxide levels in water or rinse solutions during dialyzer reprocessing. They help ensure compliance with sterilization protocols by confirming that peroxide has been adequately removed before reuse, which is critical for safety in dialysis centers.

• Are the Sterichek Residual Peroxide Reagent Strips single-use or reusable?

  The Sterichek Residual Peroxide Reagent Strips are explicitly labeled as single-use. This design ensures accuracy and reliability for each test, preventing cross-contamination or degradation of performance from repeated use.

• Do these reagent strips require sterilization before use, and if not, why?

  No, these strips are intentionally supplied as non-sterile. Since they are used for testing residual peroxide levels in already reprocessed solutions, their own sterility is not a clinical requirement. The focus is on ensuring the water or rinse solution meets safety standards, not the strips themselves.

• How should I store the Sterichek Residual Peroxide Reagent Strips to maintain their accuracy?

  Storage and handling should follow the manufacturer’s guidelines, which are detailed in the accompanying documentation. Proper storage conditions are essential to preserve the strips’ sensitivity and reliability for detecting residual peroxide levels accurately.

• What regulatory pathway was followed for the approval of these reagent strips?

  The Sterichek Residual Peroxide Reagent Strips were cleared through the FDA’s 510(k) process, specifically under the product code LIF. The clearance (K974798) was granted in 1998 as a Class II device, demonstrating substantial equivalence to a predicate device. This pathway confirms their compliance with FDA standards for safety and effectiveness.