510(k) · Cleared
ClearedRapidone-Amphetamine Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bio Medica Corp. · DOD Gas Chromatography, Amphetamine
Cleared on Oct 18, 1999 after an 88-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Oct 18, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- DOD
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK992452 Rapidone-Amphetamine TestAmerican Bio Medica Corp. · 1999
- Descendant · cites it directly · 0 of its ownK993151 Radid Drug Screen 5-Panel TestAmerican Bio Medica Corp. · 2000
Most influential descendants
Showing 1 of 1 · See all- K993151Radid Drug Screen 5-Panel TestAmerican Bio Medica Corp. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992452 | Rapidone-Amphetamine Test | American Bio Medica Corp. | 1999 | — |
| +1 | K993151 | Radid Drug Screen 5-Panel Test | American Bio Medica Corp. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
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 DOD? 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K971960 | Forefront Diagnostics, Inc. Amphetamine 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…ccordance with the requirements of 21 CFR 807.92. The assigned 510(k) is: ) .- — Predicate Deviee: Forefron I—)iagmst{cs, b hect Dfié N - Amphetamine Test (S10(k) No.X971960.) Test Description: The assay employed in the ‘RapidOne’- Ampheotumine Test is bascd on the same principlc of highly specific r… | |
| * | — | Instacheck Drug Screen - Amphetamine Test Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993151 | Radid Drug Screen 5-Panel Test | 2000 | 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?
- Of its descendants, K993151 (American Bio Medica Corp., 2000) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DOD devicesDOD Gas Chromatography, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DOD
FDA has decided no DOD device since 2007.
Median 510(k) review, days · DOD
Too few DOD 510(k)s in any year since 2007 to give a median.
Recalls per year · DOD
No recall names DOD since 2007.
Adverse event reports per year · DOD
No MAUDE report names DOD since 2007.
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 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
‘RapidOne’ - Amphetamine Test is a one-step, lateral flow immunoassay for the detection of amphetamine in urine. ‘RapidOne’ - Amphetamine Test is intended for use in the qualitative detection of amphetamine in human urine at 1000 ng/ml. ‘RapidOne’ - Amphetamine Test is intended for professional use. It is not intended for over the counter sale to non-professionals. The assay is easy to perform, but should not be used without proper supervision. This…
Read the full statement (159 words)
‘RapidOne’ - Amphetamine Test is a one-step, lateral flow immunoassay for the detection of amphetamine in urine. ‘RapidOne’ - Amphetamine Test is intended for use in the qualitative detection of amphetamine in human urine at 1000 ng/ml.
‘RapidOne’ - Amphetamine Test is intended for professional use. It is not intended for over the counter sale to non-professionals. 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 (GC/MS).
‘RapidOne’ - Amphetamine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, 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/K992452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992452: Rapidone-Amphetamine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992452
Report an extraction error
Are you the manufacturer?
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