510(k) · Cleared
ClearedDrugcheck X Multidrug Screening Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntron Bioresearch, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Sep 2, 1999 after a 17-day review. The FDA summary names no predicate by number.
- Decided
- Sep 2, 1999
- Review
- 17 days
- Class
- Class II
- Product code
- DIO
- 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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Syntron’s DrugCheck X Multidrug Screening Device (the X may be replaced by 2,8, 4,5, 6,7, or 8) is a holder for up to eight rapid, qualitative, competitive binding immunoassay strips for the detection of drugs of abuse in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DrugCheck X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine…
Read the full statement (138 words)
Syntron’s DrugCheck X Multidrug Screening Device (the X may be replaced by 2,8, 4,5, 6,7, or 8) is a holder for up to eight rapid, qualitative, competitive binding immunoassay strips for the detection of drugs of abuse in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DrugCheck X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP).The tests provide only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicatedS. Syntron’s QuikStrip DrugCheck X Multidrug Screening Device is not intended to monitor drug levels, but only to screen urines for the presence of specific drugs of abuse and their metabolites.
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/K992748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992748: Drugcheck X Multidrug Screening Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992748
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026