High-Level Disinfectant Tests (FDA)
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Microchem Laboratory is one of the few laboratories in the United States that tests High-Level Disinfectants and Sterilants for submission to FDA via the 510(k) process.
High-level disinfectants are used in medicine to decontaminate medical devices that cannot be autoclaved, that come into contact with blood and other body fluids. High-level disinfectants are most commonly used to disinfect endoscopes, which are heat-sensitive. The number of pathogenic microorganisms on used endoscopes is great and the types of microorganisms found vary, so high-level disinfectants must be exceptionally potent.
Microchem Laboratory is one of the few laboratories in the United States to conduct the suite of antimicrobial efficacy tests required by FDA for high-level disinfectant registration. The lab conducts basic in vitro tests, simulated use tests, and including the clinical “in-use” tests. At Microchem, high-level disinfectant testing is performed in compliance with FDA Good Laboratory Practice Standards (GLPs), by a team of skilled, experienced microbiologists who strive to provide a cost-effective, productive experience.
FDA requires the following tests for high-level disinfectants per its current guidance:
- AOAC Use-Dilution Test
- AOAC Sporicidal Activity Test
- AOAC Fungicidal Activity Test
- Simulated Use Tests
- Clinical In-Use Test
- Virucidal Testing (based on product’s label claims)
- Tuberculocidal Rate-of-Kill Test
- AOAC Tuberculocidal Activity of Disinfectants
- Materials Compatibility Test
- Rinsability Test
- Cytotoxicity Test
At Microchem, we strive to provide an enjoyable testing experience from study design to report generation. If your company is interested in bringing a high-level disinfectant to market, please contact the lab for free consultation and a price quote.