510(k) · Cleared
ClearedCR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Cleared on Dec 18, 2014 as substantially equivalent to K132812 (Ucp Biosciences, Inc., 2014) after a 93-day review. Its family tree reaches back 3 generations to 2009. 1 later device descends from it.
- Decided
- Dec 18, 2014
- Review
- 93 days
- Class
- Class II
- Product code
- LFG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K091588 (2009). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK091588 Ucp Home Drug Screening TestsUcp Biosciences, Inc. · 2009
- 2 generations backK130463 Ucp Home Drug Screening Test; Cards, CupsUcp Biosciences, Inc. · 2013
- 1 generation backK132812 Ucp Multi-Drug Test Key CupsUcp Biosciences, Inc. · 2014
- This deviceK142609 CR3 Keyless Split Sample Cup Nortriptyline-BuprenorphineGuangzhou Wondfo Biotech Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK151478 Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K091588 | Ucp Home Drug Screening Tests | Ucp Biosciences, Inc. | 2009 | — |
| −2 | K130463 | Ucp Home Drug Screening Test; Cards, Cups | Ucp Biosciences, Inc. | 2013 | — |
| −1 | K132812 | Ucp Multi-Drug Test Key Cups | Ucp Biosciences, Inc. | 2014 | — |
| 0 (this device) | K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +1 | K151478 | Wondfo CR3 Keyless Split Sample Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 LFG? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K132812 | Ucp Multi-Drug Test Key CupsSummary page 4…Code CFR # LFG 21CFR 862.3910 DJG 21CFR 862.3650 5. Predicate Devices: k132812 UCP Multi-Drug Test Key Cups 6. Intended Use CR3 Keyless Split Sample Cup Nortriptyline–Buprenorph… | 2014 |
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 |
|---|---|---|---|
| K151478 | Wondfo CR3 Keyless Split Sample Cup | 2015 | 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 5 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K151478 (Guangzhou Wondfo Biotech Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132812.
How does its category compare?
All LFG devicesLFG Radioimmunoassay, Tricyclic Antidepressant Drugs: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LFG
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFG
Too few LFG 510(k)s in any year since 2007 to give a median.
Recalls per year · LFG
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFG
1in 2024
MAUDE reports naming product code LFG, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
CR3 Keyless Split Sample Cup Nortriptyline—-Buprenorphine is a rapid test for the qualitative detection of Nortriptyline (a major metabolite of Tricyclic Antidepressants) and Buprenorphine in human urine at a cutoff concentration of 1000ng/mL and 10ng/mL, respectively. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained. The test is intended for…
Read the full statement (180 words)
CR3 Keyless Split Sample Cup Nortriptyline—-Buprenorphine is a rapid test for the qualitative detection of Nortriptyline (a major metabolite of Tricyclic Antidepressants) and Buprenorphine in human urine at a cutoff concentration of 1000ng/mL and 10ng/mL, respectively. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained. The test is intended for over-the-counter and for prescription use.
The test may yield preliminary positive results even when prescription drugs including Tricyclic Antidepressants and Buprenorphine are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for Nortriptyline and Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142609: CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142609
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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