510(k) · Cleared
ClearedAcro Biotech LLC Rapid Methamphetamine Urine Test; Catalog# MET001000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acro Biotech, LLC · DJC Thin Layer Chromatography, Methamphetamine
Cleared on Jun 6, 2006 after a 222-day review. The FDA summary names no predicate by number.
- Decided
- Jun 6, 2006
- Review
- 222 days
- Class
- Class II
- Product code
- DJC
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 DJC? 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 DJC device
- #1 K253705 Healgen® Accurate Oral Fluid Drug Testscore 12.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
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.
How does its category compare?
All DJC devicesDJC Thin Layer Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJC
258in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJC
No recall names DJC since 2007.
Adverse event reports per year · DJC
2in 2018
MAUDE reports naming product code DJC, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 3 | 258 | 0 | 2 |
| 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 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only.
This assay provides only preliminary results. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053033 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053033: Acro Biotech LLC Rapid Methamphetamine Urine Test; Catalog# MET001000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053033
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)
- Page last updated Nov 3, 2026