ARCHITECT CA19-9XR

Additional Manufacturer Narrative

SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-78 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-33, WITH 510K/PMA/BLA NUMBER K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CA 19-9XR FOR 45-YEAR-OLD FEMALE ONCOLOGY PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2026, SID (B)(6), INITIAL CA 19-9 RESULT= >1200 IU/L; REPEAT RESULT (1:10 AUTODILUTION)= <20 IU/L; REPEAT RESULTS= <2 IU/L; REPEAT RESULT (1:10 DILUTION)= <20 IU/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

CORRECTION TO SECTION H4 - DEVICE MFR DATE FROM 6/08/2025 TO 07/08/2025. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CA 19-9XR ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 78762FP00. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. IN HOUSE ACCURACY TESTING WAS COMPLETED FOR A RETAINED KIT OF LOT 78762FP00. 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 OF THE LOT 78762FP00. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CA 19-9XR REAGENT LOT 78762FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CA 19-9XR FOR 45-YEAR-OLD FEMALE ONCOLOGY PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2026, SID (B)(6), INITIAL CA 19-9 RESULT= >1200 IU/L; REPEAT RESULT (1:10 AUTODILUTION)= <20 IU/L; REPEAT RESULTS= <2 IU/L; REPEAT RESULT (1:10 DILUTION)= <20 IU/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.