510(k) · Cleared
ClearedAmdl-Elisa DR-70 (FDP) Immunoassay, Model DR2101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amdl, Inc. · NTY System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
Cleared on Jul 1, 2008 after a 264-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Jul 1, 2008
- Review
- 264 days
- Class
- Class II
- Product code
- NTY
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 NTY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P910053 | TOSOH BioScience AIA-PACK TM CEA Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…OF COLORECTAL CANCER Equivalency: The AMDL DR-70 is substantially equivalent to TOSOH BioScience's AIA- PACK T M CEA (P910053). Device Description: For the quantitative analysis of DR-70® (FDP) in human serum for purposes of monitoring disease progressio… |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NTY devicesNTY System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NTY
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · NTY
Too few NTY 510(k)s in any year since 2007 to give a median.
Recalls per year · NTY
No recall names NTY since 2007.
Adverse event reports per year · NTY
No MAUDE report names NTY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AMDL-ELISA DR-70® (FDP) immunoassay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of DR-70® (FDP) in human serum. Serial testing using the AMDL- ELISA DR-70® (FDP) is to be used as an aid in monitoring the disease progression in patients who have been diagnosed previously with colorectal cancer. Results of DR-70® (FDP) testing should be used in conjunction with other clinical modalities that are standard of care for monitoring disease progression in these patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072901: Amdl-Elisa DR-70 (FDP) Immunoassay, Model DR2101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072901
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026