510(k) · Cleared
ClearedModification to 'Rapid Drug Screen' 9-Panel
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 Jun 30, 1999 as substantially equivalent to K983770 (American Bio Medica Corp., 1998) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jun 30, 1999
- Review
- 14 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955935 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK955935 Triage Panel for Drugs of Abuse/Tricyclic AntidepressantsBiosite Incorporated · 1996
- This deviceK992033 Modification to 'Rapid Drug Screen' 9-PanelAmerican Bio Medica Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955935 | Triage Panel for Drugs of Abuse/Tricyclic Antidepressants | Biosite Incorporated | 1996 | — |
| 0 (this device) | K992033 | Modification to 'Rapid Drug Screen' 9-Panel | American Bio Medica Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983770 | 'Rapid Drug Screen' 9-PanelSummary page 1…cordance with the requirements of 21 C.F.R. § 807.92. The assigned 510(k) is: Predicate Devices: American BioMedica ‘Rapid Drug Screen’ 9-Panel test kit (510(k) - -No. K983770) and Biosite Diagnostics’ Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants (510(k) No. K955935). Test Description… | 1998 |
| * | K955935 | Triage Panel for Drugs of Abuse/Tricyclic AntidepressantsSummary page 1…oMedica ‘Rapid Drug Screen’ 9-Panel test kit (510(k) - -No. K983770) and Biosite Diagnostics’ Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants (510(k) No. K955935). Test Description: All of the assays employed in the Rapid Drug Screen 9-Panel are based on the same principle of the highly s… | 1996 |
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?
- None of the 2 ancestors has a recall.
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?
‘Rapid Drug Screen’ 9-Panel is a one-step, lateral flow immunoassay for the simultaneous detection of 8 abused substances and tricyclic antidepressants in urine. The “Rapid Drug Screen” 9-Panel test is intended for use in the qualitative detection of thé following 9 drugs in human urine at the following levels: d-Amphetamine 750 ng/ml Barbiturates 300 ng/ml Benzodiazepines 300 ng/ml Benzoyl ecognine 225 ng/ml Cannabinoids (11-nor-9-carboxy-delta-9-THC)…
Read the full statement (196 words)
‘Rapid Drug Screen’ 9-Panel is a one-step, lateral flow immunoassay for the simultaneous detection of 8 abused substances and tricyclic antidepressants in urine. The “Rapid Drug Screen” 9-Panel test is intended for use in the qualitative detection of thé following 9 drugs in human urine at the following levels:
d-Amphetamine 750 ng/ml
Barbiturates 300 ng/ml
Benzodiazepines 300 ng/ml
Benzoyl ecognine 225 ng/ml
Cannabinoids
(11-nor-9-carboxy-delta-9-THC) 50 ng/ml
Methamphetamine 1000 ng/ml
Opiates (codeine) 225 ng/ml
(morphine-3-glucuronide) 225 ng/ml
Phencyclidine (PCP) 19 ng/ml
Tricyclic Antidepressants 1000 ng/ml
‘Rapid Drug Screen’ 9-Panel is intended for use by professional laboratories. 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 »reliminary result for use in determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).
‘Rapid Drug Screen’ 9-Panel provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed ahalytical 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/K992033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992033: Modification to 'Rapid Drug Screen' 9-Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992033
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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