510(k) · Cleared
ClearedRapid One Step Buprenorphine Test Card
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 12, 2005 as substantially equivalent to K040316 (Microgenics Corp., 2004) after a 195-day review. Its family tree reaches back 2 generations to 2000. 18 later devices descend from it.
- Decided
- May 12, 2005
- Review
- 195 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001178 (2000). 18 later devices descend 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 deviceK042988 Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd. · 2005
- Descendant · cites it directly · 17 of its ownK060527 Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine…Alfa Scientific Designs, Inc. · 2006
- Descendant · 2 generations on · 16 of its ownK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
- Descendant · 3 generations on · 13 of its ownK152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View…Alfa Scientific Designs, Inc. · 2016
- Descendant · 4 generations on · 12 of its ownK173303 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC…Alfa Scientific Designs, Inc. · 2018
- Descendant · 5 generations on · 9 of its ownK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K060527Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test…Alfa Scientific Designs, Inc. · 2006 · cites it directly17descendants
- K063545Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette…Alfa Scientific Designs, Inc. · 2007 · 2 generations on16descendants
- K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…Alfa Scientific Designs, Inc. · 2016 · 3 generations on13descendants
- K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…Alfa Scientific Designs, Inc. · 2018 · 4 generations on12descendants
- K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…Hangzhou AllTest Biotech Co., Ltd. · 2019 · 5 generations on9descendants
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) | K042988 | Rapid One Step Buprenorphine Test Card | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | — |
| +1 | K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test… | Alfa Scientific Designs, Inc. | 2006 | — |
| +2 | K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test… | Alfa Scientific Designs, Inc. | 2007 | — |
| +3 | K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug… | Alfa Scientific Designs, Inc. | 2016 | — |
| +4 | K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)… | Alfa Scientific Designs, Inc. | 2018 | — |
| +5 | K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and… | Hangzhou AllTest Biotech Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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…DJG Regulatory Class: Class II Predicate Devices: For Sure Buprenorphine Rapid Test Card is substantially equivalent to The CEDIA9 Buprenorphine Assay cleared by FDA (K0403 16), and GC/MS for its stated intended use. Device Description: For Sure Buprenorphine Rapid Test Card consists of… | 2004 |
| * | — | GC/MS Named without a submission number |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test… | 2006 | 17 |
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, K060527 (Alfa Scientific Designs, Inc., 2006) has gone furthest, with 17 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 Test Card 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/K042988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042988: Rapid One Step Buprenorphine Test Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042988
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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