510(k) · Cleared
Recalled · Class II · 2019GI Monitor and GI Monitor Calibrators on the Access Immunoassay Systems, Model 387687, 387688
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Cleared on Dec 29, 2003 as substantially equivalent to K020566 (Fujirebio Diagnostics,Inc., 2002) after a 91-day review. Its family tree reaches back 1 generation to 2002. It has been recalled 2 times.
- Decided
- Dec 29, 2003
- Review
- 91 days
- Class
- Class II
- Product code
- NIG
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020566 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK020566 Fujirebio Diagnostics CA 19-9 RiaFujirebio Diagnostics,Inc. · 2002
- This deviceK033038 GI Monitor and GI Monitor Calibrators on the Access Immunoassay…Beckman Coulter, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020566 | Fujirebio Diagnostics CA 19-9 Ria | Fujirebio Diagnostics,Inc. | 2002 | — |
| 0 (this device) | K033038 | GI Monitor and GI Monitor Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2003 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NIG device
- #1 K253528 Atellica IM CA 19-9 IIscore 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020566 | Fujirebio Diagnostics CA 19-9 RiaSummary page 1…Cancer Predicate Device Fujirebio Diagnostics CA 19-9 RIA Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 510(k) Number: k020566 Device Description The Access GI Monitor reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2,… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2019 | Class II | Z-2241-2020 | Other | 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, Free T4-REF 33880, GI Mon-387687… |
| May 9, 2017 | Class II | Z-2638-2017 | Device Design | The Access immunoassays are susceptible to biotin interference. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K020566.
How does its category compare?
All NIG devicesNIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NIG
Too few NIG 510(k)s in any year since 2007 to give a median.
Recalls per year · NIG
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NIG
98in 2025
MAUDE reports naming product code NIG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 1 | 12 |
| 2011 | 1 | — | 1 | 8 |
| 2012 | 0 | — | 1 | 1,785 |
| 2013 | 0 | — | 0 | 182 |
| 2014 | 0 | — | 0 | 117 |
| 2015 | 0 | — | 0 | 29 |
| 2016 | 0 | — | 2 | 69 |
| 2017 | 0 | — | 0 | 98 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 135 |
| 2020 | 1 | — | 0 | 93 |
| 2021 | 0 | — | 0 | 69 |
| 2022 | 0 | — | 0 | 83 |
| 2023 | 1 | — | 0 | 129 |
| 2024 | 0 | — | 0 | 121 |
| 2025 | 0 | — | 0 | 98 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (114 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033038: GI Monitor and GI Monitor Calibrators on the Access Immunoassay Systems, Model 387687, 387688.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033038
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026