# K033038: GI Monitor and GI Monitor Calibrators on the Access Immunoassay Systems, Model 387687, 387688

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 29, 2003 after 91 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: 2 (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.
No later device cites it as a predicate yet.
0 of 2 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 1.

## Recalls of this device
- Apr 30, 2019 · Class II · Z-2241-2020: The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830
- May 9, 2017 · Class II · Z-2638-2017: The Access immunoassays are susceptible to biotin interference.

## Indications for use
The Access GI Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 19-9 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 19-9 antigen to aid in the management of pancreatic cancer patients. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer whose serum CA 19-9 antigen levels exceed 10 U/mL, the cut-off value for individuals who are Lewis blood group antigen negative. Serial testing for patient CA 19-9 antigen concentrations should be used in conjunction with other clinical methods used for monitoring pancreatic cancer.

Source page: https://510kreport.com/device/K033038
Methodology: https://510kreport.com/methodology