510(k) · Cleared
ClearedAmphetamine/Methamphetamine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LAF Gas Chromatography, Methamphetamine
Cleared on Mar 13, 2002 as substantially equivalent to K920507 (Syva Co., 1992) after a 188-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Mar 13, 2002
- Review
- 188 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920507 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK920507 Emit II Monoclonal Amphetamine/ Methamph. AssaySyva Co. · 1992
- This deviceK012998 Amphetamine/MethamphetamineAbbott Laboratories · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920507 | Emit II Monoclonal Amphetamine/ Methamph. Assay | Syva Co. | 1992 | — |
| 0 (this device) | K012998 | Amphetamine/Methamphetamine | Abbott Laboratories | 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 LAF? 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 LAF device
- #1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 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 |
|---|---|---|---|
| * | K920507 | Emit II Monoclonal Amphetamine/ Methamph. AssaySummary page 1…nzyme activity. Substantial Equivalence: The Amphetamine/Methamphetamine assay is substantially equivalent to the Emit™ [l Monoclonal Amphetamine/Methamphetamine assay (K920507) on the SYVA®-30R Analyzer. Both assays vield similar Performance Characteristics. Similarities: = Both assays… | 1992 |
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.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAF
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LAF
43in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LAF
No recall names LAF since 2007.
Adverse event reports per year · LAF
No MAUDE report names LAF 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 345 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 43 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 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?
The Amphetamine/Methamphetamine assay is used for the qualitative analysis of amphetamine/methamphetamine in human urine with a cutoff of 1,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine/methamphetamine use or overdose. The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will detect a variety of amphetamines and their metabolites. The…
Read the full statement (117 words)
The Amphetamine/Methamphetamine assay is used for the qualitative analysis of amphetamine/methamphetamine in human urine with a cutoff of 1,000 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine/methamphetamine use or overdose.
The Amphetamine/Methamphetamine assay is calibrated with d-methamphetamine and will detect a variety of amphetamines and their metabolites.
The Amphetamine/Methamphetamine assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration 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/K012998 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012998: Amphetamine/Methamphetamine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012998
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026