510(k) · Cleared
Cleared'Rapidtec' 5A Multiple Dip Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bio Medica Corp. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Jul 23, 2002 as substantially equivalent to K002447 (American Bio Medica Corp., 2000) after a 109-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jul 23, 2002
- Review
- 109 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002447 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002447 Modification to Rapid Drug Screen 9-PanelAmerican Bio Medica Corp. · 2000
- This deviceK021114 'Rapidtec' 5A Multiple Dip TestAmerican Bio Medica Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002447 | Modification to Rapid Drug Screen 9-Panel | American Bio Medica Corp. | 2000 | — |
| 0 (this device) | K021114 | 'Rapidtec' 5A Multiple Dip Test | American Bio Medica Corp. | 2002 | — |
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 DKZ? 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 DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 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? (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 |
|---|---|---|---|
| * | K002447 | Modification to Rapid Drug Screen 9-PanelSummary page 1…rement of 2 1 CFR 807.92. The assigned 51O(k) number is: KO2 1114 Predicate Device: Amepican Bio Medica Corp ‘Rapid Drug Screen’-PPmel. ( S O @ ) No. K002447.) Test Description: The assays employed in the ‘RapidTec’-SA-Multiple Dip Test is based on the same principle of highly specifi… | 2000 |
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.
- 2 other devices also cite its predicate K002447.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
‘RapidTec’-SA-Multiple Dip Test is a one-step lateral flow immunoassay for the simultaneous qualitative detection of amphetamines, benzoyl ecgonine, cannabinoids, phencyclidine, and opiates in urine. ‘RapidTec’-SA-Multiple Dip Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified…
Read the full statement (137 words)
‘RapidTec’-SA-Multiple Dip Test is a one-step lateral flow immunoassay for the simultaneous qualitative detection of amphetamines, benzoyl ecgonine, cannabinoids, phencyclidine, and opiates in urine.
‘RapidTec’-SA-Multiple Dip Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GCMS.)
‘RapidTec’-SA-Multiple Dip Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GCMS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021114: 'Rapidtec' 5A Multiple Dip Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021114
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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