510(k) · Cleared
ClearedETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eterbio, Inc. · NGL Test, Opiates, Over The Counter
Cleared on Nov 20, 2024 as substantially equivalent to K241969 (Qingdao Hightop Biotech Co., Ltd., 2024) after a 54-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Nov 20, 2024
- Review
- 54 days
- Class
- Class II
- Product code
- NGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001178 (2000). 10 ancestors in all, the oldest K973547 (1998). No later device cites it as a predicate yet.
- Root · 9 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 5 generations between
- 3 generations backK231698 AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. · 2023
- 2 generations backK233417 AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023
- 1 generation backK241969 Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel…Qingdao Hightop Biotech Co., Ltd. · 2024
- This deviceK243064 ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO…Eterbio, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 8 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 7 generations backK150606 Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug…Siemens Healthcare Diagnostics, Inc. · 2015
- 6 generations backK161216 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2017
- 5 generations backK180427 ARK Fentanyl AssayArk Diagnostics, Inc. · 2018
- 4 generations backK220046 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence…Shenzhen Superbio Technology Co., Ltd. · 2022
- 3 generations backK231698 AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. · 2023
- 2 generations backK233417 AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023
- 1 generation backK241969 Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel…Qingdao Hightop Biotech Co., Ltd. · 2024
- This deviceK243064 ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO…Eterbio, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −8 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −7 | K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| −6 | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl… | Immunalysis Corporation | 2017 | — |
| −5 | K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018 | — |
| −4 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer… | Shenzhen Superbio Technology Co., Ltd. | 2022 | — |
| −3 | K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| −2 | K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| −1 | K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®… | Qingdao Hightop Biotech Co., Ltd. | 2024 | — |
| 0 (this device) | K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO… | Eterbio, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
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 NGL? 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 NGL device
- #1 K233417 AllTest Fentanyl Urine Test Cassettescore 32.0 · 7 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 |
|---|---|---|---|
| * | K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®…Summary page 5…oxicology (91) Opiate Test System 5. Predicate Devices: Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel (K241969) 6. Indications for Use The ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) is an immunoassay intended for the qu… | 2024 |
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.
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All NGL devicesNGL Test, Opiates, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NGL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGL
39in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGL
No recall names NGL since 2007.
Adverse event reports per year · NGL
1in 2024
MAUDE reports naming product code NGL, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 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 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 13 | 40 | 0 | 1 |
| 2025 | 4 | 39 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (167 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243064 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243064: ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243064
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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