# K072901: Amdl-Elisa DR-70 (FDP) Immunoassay, Model DR2101

- Pathway: 510(k) (Traditional)
- Applicant: Amdl, Inc.
- Decided: Jul 1, 2008 after 264 days
- Product code: NTY (System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K072901
Methodology: https://510kreport.com/methodology