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Serim Disintek Reagent Strips

FDA 510(k)

Class II (US FDA 510(k))

510(k) K913943

by Serim Research Corp.

Identifiers

510(k) Number
K913943 FDA 510(k)
FDA Product Code
MED FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6885 FDA 510(k)
Regulation Number
880.6885 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Serim Disintek Reagent Strips are a type of sterilant, designed for detecting the presence of disinfectants. These strips utilize colorimetric chemistry to provide visual confirmation of disinfectant concentration, aiding in the validation of sterilization and disinfection processes in medical environments.

These reagent strips are supplied as single-use diagnostic devices, intended for use in general hospital settings. They are not sterile and require proper handling and storage in a dry environment to maintain integrity. The device holds FDA 510(k) clearance (K913943) under the classification of Class II medical devices, regulated under 21 CFR 880.6885. No MRI safety considerations apply.

Frequently asked questions

Are these reagent strips intended for use in any specific medical procedure or equipment, or are they more general-purpose for disinfection validation?

The Serim Disintek Reagent Strips are designed for general disinfection validation in medical environments, particularly within general hospital settings. They use colorimetric chemistry to visually confirm the presence and concentration of disinfectants, helping ensure proper sterilization processes for medical equipment or surfaces. Since they are classified under sterilant detection and lack procedure-specific indications, they are versatile for validating disinfection across various hospital applications.

How should I store these reagent strips to maintain their integrity, and do they require refrigeration?

The strips must be stored in a dry environment to preserve their integrity. The manufacturer explicitly states they are not sterile and does not mention refrigeration as a requirement, so room-temperature storage is appropriate as long as humidity is controlled. Avoid exposure to moisture or extreme temperatures, which could compromise their colorimetric accuracy.

Are these strips reusable, or do I need to purchase a new one for each use?

The Serim Disintek Reagent Strips are single-use diagnostic devices, meaning each strip is intended for one-time use only. After use, they should be discarded to ensure accurate and reliable results for subsequent disinfection validations.

What regulatory pathway does this device follow, and how does its classification impact its use in a hospital?

The strips hold FDA 510(k) clearance (K913943) under the classification of Class II medical devices, regulated under 21 CFR 880.6885. This classification means they are subject to stricter controls than lower-risk devices but do not require the same rigorous premarket approval process as higher-risk Class III devices. Hospitals can use them with confidence, knowing they meet FDA standards for sterilant detection in general hospital settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Serim - The Test Strip Specialists, PDF Research Corporation Product Catalog, SERIM DISINTEK REAGENT STRIPS (K913943) — FDA 510(k) | Innolitics, Serim Research Corp. FDA 510 (k) Products (1990-2012)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Serim Research Corp.

Sources (1)

  • FDA 510(k) K913943 24 fields · synced Sep 19, 2026