510(k) Report

510(k) · Cleared

Cleared

Instant-View Tca Urine Test

K022693510(k) AbbreviatedCleared Dec 9, 2002118-day reviewClass II21 CFR 862.3910

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. · MLK Thin Layer Chromatography, Tricyclic Antidepressant Drugs

Cleared on Dec 9, 2002 after a 118-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 17 later devices descend from it.

Decided
Dec 9, 2002
Review
118 days
Class
Class II
Product code
MLK
Recalls
None
Predicates
1

17 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant cleared2016: 1 descendant cleared2018: 3 descendants cleared2019: 1 descendant cleared2023: 1 descendant cleared2025: 4 descendants cleared2024: 2 descendants cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK022693 Instant-View Tca Urine TestAlfa Scientific Designs, Inc. · 2002
  2. Descendant · cites it directly · 16 of its ownK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
  3. Descendant · 2 generations on · 13 of its ownK152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View…Alfa Scientific Designs, Inc. · 2016
  4. 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
  5. Descendant · 4 generations on · 9 of its ownK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
  6. 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
0 (this device)K022693Instant-View Tca Urine TestAlfa Scientific Designs, Inc.2002—
+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 K022693, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 MLK? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK981605SureStep Drug Screen TCA Test
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…ass I1 Date of Summary Preparation November, 5,2002 Predicate Device SureStepTMDrug Screen TCA Test, Applied Biotech, Inc., K981605 Device Description A one-step lateral flow chromatographic immunoassay. The test strip in the devic…

What descends from it? (17)

See all 17

1 later device cites 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

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?

  • Of its descendants, K063545 (Alfa Scientific Designs, Inc., 2007) has gone furthest, with 16 descendants of its own.

How does its category compare?

All MLK devices

MLK Thin Layer Chromatography, Tricyclic Antidepressant Drugs: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MLK

FDA has decided no MLK device since 2007.

Median 510(k) review, days · MLK

Too few MLK 510(k)s in any year since 2007 to give a median.

Recalls per year · MLK

No recall names MLK since 2007.

Adverse event reports per year · MLK

No MAUDE report names MLK since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

It is for health care professional, in-vitro diagnostic use only. This device is a one-step immunoassay intended to provide qualitative rapid detection of tricyclic antidepressants (TCA) at a cutoff concentration of 1,000 ng/ml in human urine. It is for health care professional use only. Instant-View TCA Urine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed…

Read the full statement (103 words)

It is for health care professional, in-vitro diagnostic use only.

This device is a one-step immunoassay intended to provide qualitative rapid detection of tricyclic antidepressants (TCA) at a cutoff concentration of 1,000 ng/ml in human urine. It is for health care professional use only.

Instant-View TCA Urine 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 Spectrometry (GC/MS) 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 used.

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 MLK

The MLK category page

  • K010734Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21Branan Medical Corp. · 2001

https://510kreport.com/device/K022693 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022693: Instant-View Tca Urine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022693

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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