510(k) · Cleared

Cleared

CR3 Keyless Split Sample Cup Secobarbital- Methadone

K143535510(k) TraditionalCleared Jan 13, 201529-day reviewClass II21 CFR 862.3150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Guangzhou Wondfo Biotech Co., Ltd. · DIS Enzyme Immunoassay, Barbiturate

Cleared on Jan 13, 2015 as substantially equivalent to K122904 (Guangzhou Wondfo Biotech Co., Ltd., 2012) after a 29-day review. Its family tree reaches back 1 generation to 2012. 1 later device descends from it.

Decided: Jan 13, 2015
Review: 29 days
Class: Class II
Product code: DIS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K122904 (2012). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK122904 Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU…Guangzhou Wondfo Biotech Co., Ltd. · 2012
This deviceK143535 CR3 Keyless Split Sample Cup Secobarbital- MethadoneGuangzhou Wondfo Biotech Co., Ltd. · 2015
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
−1	K122904	Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU; W2005-CU…	Guangzhou Wondfo Biotech Co., Ltd.	2012	—
0 (this device)	K143535	CR3 Keyless Split Sample Cup Secobarbital- Methadone	Guangzhou Wondfo Biotech Co., Ltd.	2015	—
+1	K151478	Wondfo CR3 Keyless Split Sample Cup	Guangzhou Wondfo Biotech Co., Ltd.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K143535, 2012–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DIS? 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

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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	Applicant	Decided	Recalls
*	K122904	Wondfo Multi-Drug Urine Test Cup Model W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU… Summary page 4 …21 CFR, 862.3150 Barbiturate Test System Toxicology DJR 21 CFR, 862.3620 Methadone Test System Toxicology 5. Predicate Devices: K122904 Wondfo Multi-Drug Urine Test Cup 6. Intended Use: CR3 Keyless Split Sample Cup Secobarbital-Methadon…	Guangzhou Wondfo Biotech Co., Ltd.	2012	—

Also cleared against K122904: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K151478	Wondfo CR3 Keyless Split Sample Cup	Guangzhou Wondfo Biotech Co., Ltd.	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?

Its one ancestor has no 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 K122904.

How does its category compare?

All DIS devices

DIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · DIS

1in 2016

2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIS

29in 2015

2007high 331 (2007) · low 29 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DIS

1in 2016

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DIS

1in 2018

2007high 1 (2007) · low 0 (2009)2025

MAUDE reports naming product code DIS, 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	3	331	0	1
2008	0	—	0	1
2009	0	—	0	0
2010	0	—	0	0
2011	2	—	1	0
2012	0	—	1	0
2013	0	—	0	0
2014	2	—	0	0
2015	3	29	0	0
2016	1	—	1	0
2017	0	—	0	0
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

CR3 Keyless Split Sample Cup Secobarbital-Methadone is a rapid test for the qualitative detection of Secobarbital and Methadone in human urine at a cutoff concentration of 300ng/mL for each of the drugs. The test may yield preliminary positive results when prescription drugs Secobarbital and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital and Methadone in urine. The test provides…

Read the full statement (126 words)

The test may yield preliminary positive results when prescription drugs Secobarbital and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital and Methadone 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. Gas Chromatography/Mass Spectrometry 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/K143535 · printed Nov 5, 2026

Cite this page

510(k) Report. “K143535: CR3 Keyless Split Sample Cup Secobarbital- Methadone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143535

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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