510(k) · Cleared
ClearedInstant-View Morphine Urine Cassette Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Scientific Designs, Inc. · DPK Liquid Chromatography, Morphine
Cleared on Jul 5, 2000 as substantially equivalent to K972571 (Drial Consultants, Inc., 1997) after a 190-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jul 5, 2000
- Review
- 190 days
- Class
- Class II
- Product code
- DPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972571 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972571 Quikstrip One Step Opiates TestDrial Consultants, Inc. · 1997
- This deviceK994404 Instant-View Morphine Urine Cassette TestAlfa Scientific Designs, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972571 | Quikstrip One Step Opiates Test | Drial Consultants, Inc. | 1997 | — |
| 0 (this device) | K994404 | Instant-View Morphine Urine Cassette Test | Alfa Scientific Designs, Inc. | 2000 | — |
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 DPK? 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 |
|---|---|---|---|
| * | K972571 | Quikstrip One Step Opiates TestSummary page 1…ed devices for the similar intended use. The device used for comparison study is QuikStrip One Step Opiate Test, manufactured by Syntron Bioresearch, Inc. with 510(K) #: K972571, Date of Approval: 08/20/97. Predicate Device This test is a one-step lateral flow chromatographic Device Description {mmunoas… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 1 other device also cites its predicate K972571.
How does its category compare?
All DPK devicesDPK Liquid Chromatography, Morphine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPK
FDA has decided no DPK device since 2007.
Median 510(k) review, days · DPK
Too few DPK 510(k)s in any year since 2007 to give a median.
Recalls per year · DPK
No recall names DPK since 2007.
Adverse event reports per year · DPK
1in 2025
MAUDE reports naming product code DPK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 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 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Instant-View Morphine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only. The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommends the screening levels for Morphine to be at a concentration of 2000 ng/ml. This Test provides only a…
Read the full statement (122 words)
Instant-View Morphine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only.
The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommends the screening levels for Morphine to be at a concentration of 2000 ng/ml.
This Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
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/K994404 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994404: Instant-View Morphine Urine Cassette Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994404
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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