510(k) · Cleared
ClearedHightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qingdao Hightop Biotech Co., Ltd. · NGL Test, Opiates, Over The Counter
Cleared on Aug 14, 2024 as substantially equivalent to K233417 (Hangzhou AllTest Biotech Co., Ltd., 2023) after a 40-day review. Its family tree reaches back 8 generations to 2000. 1 later device descends from it.
- Decided
- Aug 14, 2024
- Review
- 40 days
- Class
- Class II
- Product code
- NGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001178 (2000). 9 ancestors in all, the oldest K973547 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 7 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 6 generations backK150606 Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug…Siemens Healthcare Diagnostics, Inc. · 2015
- 5 generations backK161216 Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2017
- 4 generations backK180427 ARK Fentanyl AssayArk Diagnostics, Inc. · 2018
- 3 generations backK220046 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence…Shenzhen Superbio Technology Co., Ltd. · 2022
- 2 generations backK231698 AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. · 2023
- 1 generation backK233417 AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023
- This deviceK241969 Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel…Qingdao Hightop Biotech Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK243064 ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO…Eterbio, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl…Eterbio, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −7 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −6 | K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug… | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| −5 | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl… | Immunalysis Corporation | 2017 | — |
| −4 | K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018 | — |
| −3 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer… | Shenzhen Superbio Technology Co., Ltd. | 2022 | — |
| −2 | K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| −1 | K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| 0 (this device) | K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®… | Qingdao Hightop Biotech Co., Ltd. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K233417 | AllTest Fentanyl Urine Test CassetteSummary page 5…CFR § 862.3650 Toxicology (91) Opiate Test System 5. Predicate Devices: AllTest Fentanyl Urine Test Cassette (K233417) 6. Indications for Use Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel is a competitive binding, lateral fl… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl… | 2024 | 0 |
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 7 companies; a new generation was cleared every 1.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K243064 (Eterbio, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K233417.
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?
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl and norfentanyl, the major metabolite of fentanyl in human urine at the cut-off concentrations listed below: Analyte Cut-off Level Fentanyl (FYL) 1ng/mL Norfentanyl (NFYL) 5ng/mL The test is available in a single test of FYL or NFYL or a Double panel of FYL and NFYL. It is intended for OTC…
Read the full statement (240 words)
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl and norfentanyl, the major metabolite of fentanyl in human urine at the cut-off concentrations listed below:
Analyte Cut-off Level
Fentanyl (FYL) 1ng/mL
Norfentanyl (NFYL) 5ng/mL
The test is available in a single test of FYL or NFYL or a Double panel of FYL and NFYL. It is intended for OTC use.
The test provides only a preliminary test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl and norfentanyl, the major metabolite of fentanyl in human urine at the cut-off concentrations listed below:
Analyte Calibrator Cut-off level
Fentanyl (FYL) Fentanyl 1ng/mL
Norfentanyl (NFYL) Norfentanyl 5ng/mL
The test is available in a single test of FYL or NFYL or a Double panel of FYL and NFYL.
The test panel provides only a preliminary test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
The test panel is not intended to distinguish between prescription use or abuse of fentanyl. Clinical consideration and professional judgment should be applied to the test result, particularly in evaluating a preliminary positive result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241969: Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241969
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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