# K052000: Architect CA 19-9XR Assay

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Oct 25, 2005 after 92 days
- Product code: NIG (System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020566 (2002). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020566: Fujirebio Diagnostics CA 19-9 Ria, Fujirebio Diagnostics,Inc. (2002) Summary page 3.

## Most influential descendants
- K191973: Lumpipulse G CA19-9-N (2019), 1 descendant of its own
- K200997: Lumipulse G CA19-9-N (2020), 0 descendants of its own

## Recalls of this device
- May 30, 2012 · Class II · Z-1904-2012: The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.

## Indications for use
The ARCHITECT CA 19-9xR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA 19-9xR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods. Patients known to be genotypically negative for the Lewis blood group antigen will be unable to produce the CA 19-9 antigen even in the presence of malignant tissue. Phenotyping for the presence of the Lewis antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotypically positive for the Lewis antigen may produce varying levels of CA 19-9 based on gene dosage effect. The ARCHITECT CA 19-9xR Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma. Refer to the ARCHITECT CA 19-9xR reagent package insert for additional information. The ARCHITECT CA 19-9xR Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative measurement of 1116-NS-19-9 reactive determinants in human serum or plasma. Refer to the ARCHITECT CA 19-9xR reagent package insert for additional information.

Source page: https://510kreport.com/device/K052000
Methodology: https://510kreport.com/methodology