510(k) · Cleared
ClearedFor Sure One Step Buprenorphine Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin New Bay Bioresearch Co., Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on May 10, 2005 as substantially equivalent to K040316 (Microgenics Corp., 2004) after a 193-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- May 10, 2005
- Review
- 193 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001178 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 1 generation backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- This deviceK042990 For Sure One Step Buprenorphine Test StripTianjin New Bay Bioresearch Co., Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK122064 Forsure One Step Buprenorphine Cup Test DeviceTianjin New Bay Bioresearch Co., Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K122064Forsure One Step Buprenorphine Cup Test DeviceTianjin New Bay Bioresearch Co., Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −1 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| 0 (this device) | K042990 | For Sure One Step Buprenorphine Test Strip | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | — |
| +1 | K122064 | Forsure One Step Buprenorphine Cup Test Device | Tianjin New Bay Bioresearch Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K040316 | Cedia Buprenorphine AssaySummary page 1…tory Class: Class II Predicate Devices: For Sure One Step Buprenorphine Strip Test Device is substantially equivalent to The CEDIAV Buprenorphine Assay cleared by FDA (K0403 16), and GC/MS for its stated intended use. Device Description: The For Sure One Step Buprenorphine Strip Test Devi… | 2004 |
| * | — | GC/MS Named without a submission number |
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 |
|---|---|---|---|
| K122064 | Forsure One Step Buprenorphine Cup Test Device | 2013 | 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 4.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K122064 (Tianjin New Bay Bioresearch Co., Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K040316.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
For Sure One Step Buprenorphine Strip Test Device is an immunochromatographic immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test results particularly when preliminary results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042990 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042990: For Sure One Step Buprenorphine Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042990
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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