510(k) Report

510(k) · Cleared

Cleared

Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test; Instant-Confirmatory Bup/Nbup Urine Test

K060527510(k) AbbreviatedCleared Jul 25, 2006147-day reviewClass II21 CFR 862.3650

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

Alfa Scientific Designs, Inc. · DJG Enzyme Immunoassay, Opiates

Cleared on Jul 25, 2006 as substantially equivalent to K042988 (Tianjin New Bay Bioresearch Co., Ltd., 2005) after a 147-day review. Its family tree reaches back 3 generations to 2000. 17 later devices descend from it.

Decided
Jul 25, 2006
Review
147 days
Class
Class II
Product code
DJG
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K001178 (2000). 17 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2007: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant cleared2018: 3 descendants cleared2019: 1 descendant cleared2023: 1 descendant cleared2025: 4 descendants cleared2024: 2 descendants cleared2026: 2 descendants clearedK001178 · Cedia Dau 6-Acetylmorphine Assay · Microgenics Corp. · 2000K040316 · Cedia Buprenorphine Assay · Microgenics Corp. · 2004K042988 · Rapid One Step Buprenorphine Test Card · Tianjin New Bay Bioresearch Co., Ltd. · 2005200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 2 descendants7 generations forward: 5 descendants8 generations forward: 1 descendant K042988 · Rapid One Step Buprenorphine Test Card · Tianjin New Bay Bioresearch Co., Ltd. · 2005K040316 · Cedia Buprenorphine Assay · Microgenics Corp. · 2004K001178 · Cedia Dau 6-Acetylmorphine Assay · Microgenics Corp. · 20000+5
  1. Root · 3 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
  2. 2 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
  3. 1 generation backK042988 Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd. · 2005
  4. This deviceK060527 Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine…Alfa Scientific Designs, Inc. · 2006
  5. Descendant · cites it directly · 16 of its ownK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
  6. Descendant · 2 generations on · 13 of its ownK152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View…Alfa Scientific Designs, Inc. · 2016
  7. Descendant · 3 generations on · 12 of its ownK173303 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC…Alfa Scientific Designs, Inc. · 2018
  8. Descendant · 4 generations on · 9 of its ownK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
  9. Descendant · 5 generations on · 8 of its ownK233019 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test…Hangzhou AllTest Biotech Co., Ltd. · 2023

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12013: 12016: 12018: 32019: 12023: 12024: 22025: 42026: 2
2007high 4 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 17 · See all
  • K063545Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette…Alfa Scientific Designs, Inc. · 2007 · cites it directly16descendants
  • K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…Alfa Scientific Designs, Inc. · 2016 · 2 generations on13descendants
  • K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…Alfa Scientific Designs, Inc. · 2018 · 3 generations on12descendants
  • K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…Hangzhou AllTest Biotech Co., Ltd. · 2019 · 4 generations on9descendants
  • K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…Hangzhou AllTest Biotech Co., Ltd. · 2023 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001178Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp.2000—
−2K040316Cedia Buprenorphine AssayMicrogenics Corp.2004—
−1K042988Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd.2005—
0 (this device)K060527Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test…Alfa Scientific Designs, Inc.2006—
+1K063545Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test…Alfa Scientific Designs, Inc.2007—
+2K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug…Alfa Scientific Designs, Inc.2016—
+3K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)…Alfa Scientific Designs, Inc.2018—
+4K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and…Hangzhou AllTest Biotech Co., Ltd.2019—
+5K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel…Hangzhou AllTest Biotech Co., Ltd.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201310
201610
201830
201910
202310
202420
202540
202620
FIG. 1 — Lineage of K060527, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K042988Rapid One Step Buprenorphine Test Card
Summary page 1
…Opiates Product Code: DJG Date of Summary Preparation February 20, 2006 510K Number: K042988 OneStep Buprenorphine Test, New Bay Bioresearch, Co. Ltd. A one-ste…
Tianjin New Bay Bioresearch Co., Ltd.2005—

What descends from it? (17)

See all 17

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063545Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette…Alfa Scientific Designs, Inc.200716
K100051Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of…Alfa Scientific Designs, Inc.20100

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 6 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K063545 (Alfa Scientific Designs, Inc., 2007) has gone furthest, with 16 descendants of its own.

How does its category compare?

All DJG devices

DJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DJG

3in 2025

2007: 22008: 22009: 22010: 62011: 62012: 52013: 52014: 92015: 122016: 22017: 42018: 52019: 32020: 52021: 32022: 22023: 102024: 52025: 32026 (partial year): 3
2007high 12 (2015) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DJG

31in 2025

2010: 187 days median2011: 233 days median2012: 95 days median2013: 60 days median2014: 62 days median2015: 141 days median2017: 101 days median2018: 134 days median2019: 235 days median2020: 30 days median2021: 422 days median2023: 140 days median2024: 150 days median2025: 31 days median2026 (partial year): 157 days median
2007high 422 (2021) · low 30 (2020)2026

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

Recalls per year · DJG

2in 2025

2011: 12019: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · DJG

1in 2025

2011: 42012: 12013: 42015: 32016: 22017: 12018: 12021: 22022: 12024: 32025: 1
2007high 4 (2011) · low 0 (2007)2025

MAUDE reports naming product code DJG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20082—00
20092—00
2010618700
2011623314
201259501
201356004
201496200
20151214103
20162—02
2017410101
2018513401
2019323510
202053000
2021342202
20222—01
20231014000
2024515003
202533121
202631570—

What is it indicated for?

The proposed BUP/NBUP Urine Test is a qualitative immunoassay for the rapid detection of buprenorphine and norbuprenorphine from human urine specimens. The test provides only a preliminary result. It is for health care professional use only.

This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Indications for use as stated in the FDA summary.

More from Alfa Scientific Designs, Inc.

44 FDA decisions under this applicant name. See the company

  • K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc. · 2026
  • K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine…Alfa Scientific Designs, Inc. · 2018
  • K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc. · 2018
  • K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)Alfa Scientific Designs, Inc. · 2016
  • K131645Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)Alfa Scientific Designs, Inc. · 2013

Recent decisions in DJG

The DJG category page

  • K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
  • K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026
  • K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc. · 2026
  • K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation · 2025
  • K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen®…Healgen Scientific,, LLC · 2025

https://510kreport.com/device/K060527 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060527: Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test; Instant-Confirmatory Bup/Nbup Urine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060527

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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