510(k) · Cleared
ClearedAssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Assure Tech. Co., Ltd. · DIS Enzyme Immunoassay, Barbiturate
Cleared on Jun 4, 2015 as substantially equivalent to K052115 (First Check Diagnostics, LLC, 2005) after a 29-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Jun 4, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050186 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK050186 Ameditech Immutest Multi-Drug Screen Panel IiiAmeditech, Inc. · 2005 · Recalled
- 1 generation backK052115 First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc)…First Check Diagnostics, LLC · 2005 · Recalled
- This deviceK151211 AssureTech Secobarbital Strip, AssureTech Oxycodone Strip…Assure Tech. Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050186 | Ameditech Immutest Multi-Drug Screen Panel Iii | Ameditech, Inc. | 2005 | 3 |
| −1 | K052115 | First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine… | First Check Diagnostics, LLC | 2005 | 86 |
| 0 (this device) | K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech… | Assure Tech. Co., Ltd. | 2015 | — |
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 DIS? 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? (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 |
|---|---|---|---|
| * | K052115 | First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp)…Summary page 5…21 CFR, 862.3150 Barbiturate Test System Toxicology DJG 21 CFR, 862.3650 Opiate Test System Toxicology 5. Predicate Devices: K052115 FIRST CHECK DIAGNOSTICS LLC FIRST CHECK MULTI DRUG CUP 12 6. Intended Use The AssureTech Secobarbital Strip test is an imm… | 2005 |
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 12 other devices also cite its predicate K052115.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
MAUDE reports naming product code DIS, 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 | 3 | 331 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 29 | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 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?
The AssureTech Secobarbital Strip test is an immunochromatographic assay for the qualitative determination of Secobarbital in human urine at a Cut-Off concentration of 300ng/mL. The test may yield preliminary positive results when prescription drug Secobarbital is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital in urine. The test provides only preliminary test results. A more specific…
Read the full statement (654 words)
The AssureTech Secobarbital Strip test is an immunochromatographic assay for the qualitative determination of Secobarbital in human urine at a Cut-Off concentration of 300ng/mL.
The test may yield preliminary positive results when prescription drug Secobarbital is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Oxycodone Strip test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100ng/mL.
The test may yield preliminary positive results when prescription drug Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Secobarbital/Oxycodone Panel Dip test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL, respectively.
The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Secobarbital/Oxycodone Quick Cup test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL, respectively.
The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Secobarbital/Oxycodone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL, respectively.
The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151211: AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151211
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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