# K243064: ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test

- Pathway: 510(k) (Traditional)
- Applicant: Eterbio, Inc.
- Decided: Nov 20, 2024 after 54 days
- Product code: NGL (Test, Opiates, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001178 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241969: Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel, Qingdao Hightop Biotech Co., Ltd. (2024) Summary page 5.

## Indications for use
The ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine: Drug (Identifier) Calibrator Cut-off Level Fentanyl (FYL) Fentanyl 1ng/mL Norfentanyl (NFYL) Norfentanyl 5ng/mL The test is available as a single panel for FYL or NFYL, or as a dual panel combining both FYL and NFYL. It provides a preliminary screening result only. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method. The ETERBIO Fentanyl/Norfentanyl Home Test is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine: Drug (Identifier) Calibrator Cut-off Level Fentanyl (FYL) Fentanyl 1ng/mL Norfentanyl (NFYL) Norfentanyl 5ng/mL The test is available as a single panel for FYL or NFYL, or as a dual panel combining both FYL and NFYL. This test provides only preliminary results. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.

Source page: https://510kreport.com/device/K243064
Methodology: https://510kreport.com/methodology