New, Now, and in the Know at ATS Labs
Testing for FDA Regulated Products

Are you looking for a knowledgeable, responsive antimicrobial laboratory to assist you in developing data for your FDA regulated products? ATS is just the lab for you! With our understanding of the product development process and extensive bacterial and viral library, our experienced staff is uniquely prepared to help you complete your project quickly.

Our areas of testing expertise include:

Reuseable Medical Device Validations

By applying our strengths, ATS Labs has become the leader in validating the cleaning and disinfection of Blood Glucose Monitoring Systems (BGMS). We work closely with you to understand your device, and use FDA, AAMI, ISO, ASTM and ANSI methods and guidances to prepare your customized validation.

Antimicrobial Wound Care/Topical Antimicrobial Products

Simple evaluations can often garner the most information. Initial evaluations of antimicrobial wound care products include zone of inhibition and MIC/MBC tests. We also offer ASTM 2315 (time-kill), ASTM 2149 (Antimicrobial evaluation of immobilized agents) and ASTM 2180 (Antimicrobial evaluation of polymeric or hydrophobic materials).

Antiseptic Handwashes and Surgical Scrubs

We offer time-kill testing (ASTM 2315), outlined in the FDA's Tentative Final Monograph for Healthcare Antiseptic Drug Products, as a first step in investigating your products efficacy. In addition, we can quickly assist you in establishing the activity/persistence of your product using ex-vivo testing methodologies on simulated human skin.

Contact Lens Care Products

We can help you complete testing needed to comply with the FDA requirements outlined in "Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products" and ISO 14729.

High Level Disinfectants

We offer the entire suite of testing required to satisfy the requirements of the FDA "Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants". We can help you through the entire process including simulated and clinical use testing of your disinfectant on instruments, and reuse evaluations!

Washer/Disinfectors

Our dedicated testing room provides the space and our knowledgeable staff provides the expertise to allow us to be your partner in validating the performance of your washer/disinfector. We work closely with you to understand the nuances of your equipment and follow FDA, AAMI, ISO, ASTM and ANSI methods, allowing us to accurately define your equipments capabilities and giving you solid data to support your [510(k)] submission.

Don’t see your area of interest listed above? As the leaders in testing innovation, we look forward to discussing your distinct needs. We encourage you to call us. For specific information about testing FDA regulated products, contact Amy Jeske at 651-379-5526 or amy.jeske@ats-labs.com.

There's more that's new, now at ATS Labs

 - ATS Labs has Murine Norovirus
 - Testing Food Borne Bacteria to Prevent Illnesses
 - Antimicrobial Device Testing Finds Space at ATS Labs
 - Letter from the President - ATS Labs Attracts New Partner
 - Testing for FDA Regulated Products
 - Newly Acquired Organisms
>> Read more