510(k) · Cleared

Cleared

'Rapidtec'-5M-Multiple Dip Test

K023869510(k) TraditionalCleared Apr 30, 2003161-day reviewClass II21 CFR 862.3620

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

American Bio Medica Corp. · DJR Enzyme Immunoassay, Methadone

Cleared on Apr 30, 2003 as substantially equivalent to K012159 (American Bio Medica Corp., 2001) after a 161-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Apr 30, 2003
Review: 161 days
Class: Class II
Product code: DJR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K012159 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK012159 Rapid Drug ScreenAmerican Bio Medica Corp. · 2001
This deviceK023869 'Rapidtec'-5M-Multiple Dip TestAmerican Bio Medica Corp. · 2003
Descendant · cites it directly · 0 of its ownK073078 Rapid Tox CupAmerican Bio Medica Corp. · 2008

Most influential descendants

Showing 1 of 1 · See all

K073078Rapid Tox CupAmerican Bio Medica Corp. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K012159	Rapid Drug Screen	American Bio Medica Corp.	2001	—
0 (this device)	K023869	'Rapidtec'-5M-Multiple Dip Test	American Bio Medica Corp.	2003	—
+1	K073078	Rapid Tox Cup	American Bio Medica Corp.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K023869, 2001–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DJR? 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K012159	Rapid Drug Screen Summary page 1 …he requirement of 21 CFR 807.92. The assigned 5 1O(k) number is: Predicate Device: American Bio Medica Corp. ‘Rapid Drug Screen’-9-Panel. (5 lo@) No. K012159.) Test Description: The assays employed in the ‘RapidTec’-5M-Multiple Dip Test is based on the same principle of highly specifi…	American Bio Medica Corp.	2001	—

Also cleared against K012159: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073078	Rapid Tox Cup	American Bio Medica Corp.	2008	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?

Its one ancestor has no recall.
Of its descendants, K073078 (American Bio Medica Corp., 2008) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K012159.

How does its category compare?

All DJR devices

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

FDA decisions per year · DJR

1in 2019

2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DJR

59in 2015

2007high 469 (2010) · low 59 (2015)2026

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

Recalls per year · DJR

1in 2010

2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DJR

1in 2025

2007high 6 (2011) · low 0 (2007)2025

MAUDE reports naming product code DJR, 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	—	2	0
2009	1	—	1	0
2010	3	469	1	3
2011	0	—	0	6
2012	0	—	0	1
2013	1	—	0	0
2014	0	—	0	2
2015	3	59	0	2
2016	1	—	0	1
2017	1	—	0	0
2018	1	—	0	0
2019	1	—	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?

‘RapidTec’-SM-Mdtiple Dip Tes? is a om-step lateral flow immunoassay for the simultaneousqualitative detcction of inetharnphetamjnes, b e b y 1 ecgonine, cannabinoids, phencyclidine, and opiates in urine. ‘RapidTec’-SMrnultiple Dip Test Wiu dctect these &es #t the following concentrations: Methamphetamines: 1000 @ml Benzoyl ecgoninc 300 ng/ml Cannabinoids 50 ng/mI Phencylidine 25 @ml Opiates 2000 nghnl 300 ndmJ ‘Rapid Ted-5M-Multiple Dip Test is intended…

Read the full statement (174 words)

‘RapidTec’-SMrnultiple Dip Test Wiu dctect these &es #t the following concentrations:

Methamphetamines: 1000 @ml

Benzoyl ecgoninc 300 ng/ml

Cannabinoids 50 ng/mI

Phencylidine 25 @ml

Opiates 2000 nghnl

300 ndmJ

‘Rapid Ted-5M-Multiple Dip Test is intended for professional use. It is not intended for over-thc-counter sale to nonprofessionals. The assay is casy to perform, but should not bc used without proper supervision. This immunoassay is a simplified, qualitative scrccnhg method that provides only a preliminary result for use in determining thc rmd for additional or confirmatory testing, i.e. gas chromatogaphy/mass spectromctry (GCIMS).

‘RapidTec’-SM-MultipleDip T e t provides onty a preliminary analytical result A more specific alternate cticmical method must be used in order to obtain. A more confirmed resuIt. G C M S is the preferred confirmatory method. Clinical and professional judgment should he apptied to any drug of abuse test result, particularly whcn pdiminary results are used.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023869 · printed Nov 5, 2026

Cite this page

510(k) Report. “K023869: 'Rapidtec'-5M-Multiple Dip Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023869

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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