ARCHITECT CA19-9XR REAGENT KIT

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33, WITH 510K NUMBER K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CA 19-9XR FOR ONE PATIENT WITH A HISTORY OF PANCREATIC CANCER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, INITIAL CA 19-9 RESULT= 10 U/ML; (B)(6) 2025, REPEAT RESULT (AFTER 2 DAYS STORAGE)= 37 U/ML; REPEAT RESULT (RECENTRIFUGED)= 14 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CA 19-9XR ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 70448FP00. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOT 70448FP00, WHICH DID NOT SHOW ANY RELATED POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES, OR DEVIATIONS. IN HOUSE ACCURACY TESTING WAS PERFORMED TO EVALUATE THE PERFORMANCE OF THE REAGENT LOT 70448FP00. AN INTERNAL CA 19-9XR PANEL WAS TESTED WITH RETAINED KITS OF THE COMPLAINT REAGENT LOT. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC OR DEFICIENCY OF THE ARCHITECT CA 19-9XR LOT 70448FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CA 19-9XR FOR ONE PATIENT WITH A HISTORY OF PANCREATIC CANCER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, INITIAL CA 19-9 RESULT= 10 U/ML; (B)(6) 2025, REPEAT RESULT (AFTER 2 DAYS STORAGE) = 37 U/ML; REPEAT RESULT (RECENTRIFUGED)= 14 U/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.