Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

CLOSEOUT LETTER Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. MARCS-CMS 576934 — March 16, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Product: Medical Devices Recipient: Recipient Name Jonathan Chapman Recipient Title President and Chief Financial Officer Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. 4600 Anson Blvd Whitestown , IN 46075 United States Issuing Office: Division of Medical Device and Radiological Health Operations East United States Dear Mr. Chapman: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, CMS# 576934, dated July 31, 2019 for your firm’s Indianapolis, IN location. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Gina M. Brackett Director, Compliance Branch Office of Medical Devices & Radiological Health Division One - East Content current as of: 03/23/2023 Regulated Product(s) Medical Devices