510(k) · Cleared
ClearedOratect Oral Fluid Drug Screen Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Branan Medical Corporation · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Apr 11, 2012 as substantially equivalent to K992918 (OraSure Technologies, Inc., 2000) and 4 other predicates after a 527-day review. Its family tree reaches back 2 generations to 1992. 6 later devices descend from it.
- Decided
- Apr 11, 2012
- Review
- 527 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K924446 (1992). 7 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
- 1 generation backK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
- This deviceK103227 Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
- Descendant · cites it directly · 3 of its ownK171403 OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK181305 OralTox Oral fluid Drug TestPremier Biotech, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK132688 Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid…Biochemical Diagnostics, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK253705 Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK240287 LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018 · cites it directly3descendants
- K181305OralTox Oral fluid Drug TestPremier Biotech, Inc. · 2018 · 2 generations on1descendant
- K132688Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZBiochemical Diagnostics, Inc. · 2013 · cites it directly1descendant
- K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026 · 3 generations on0descendants
- K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924446 | Micro-Plate Opiates Assay | Solarcare Technologies Corp,Inc. | 1992 | — |
| −1 | K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | OraSure Technologies, Inc. | 1998 | — |
| 0 (this device) | K103227 | Oratect Oral Fluid Drug Screen Devices | Branan Medical Corporation | 2012 | — |
| +1 | K171403 | OralTox Oral Fluid Drug Test | Premier Biotech, Inc. | 2018 | — |
| +2 | K181305 | OralTox Oral fluid Drug Test | Premier Biotech, Inc. | 2018 | — |
| +1 | K132688 | Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control… | Biochemical Diagnostics, Inc. | 2013 | — |
| +3 | K253705 | Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | 2026 | — |
| +2 | K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | Hangzhou Laihe Biotech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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 3.0 · 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? (5)
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 |
|---|---|---|---|
| * | K992918 | STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103ISummary page 2…_________________Device 510(k) # Amphetamine Amphetamine-Specific Intercept~' Micro-plate FIA K9929 18 Cocaine Cocaine Metabolites Intercepto Micro-plate FIA KOO 1197 Methamphetamine Metham… | 2000 |
| * | K001197 | Cocaine Metabolite Intercept Micro-Plate Eia | 2000 |
| * | K002375 | STC Cannabinoids Intercept Micro-Plate Eia, Model 1118ISummary page 2…tamine Methamphetamine Intercepto Micro-plate FIA KOOI 197 Cannabinoids Cannabinoids Intercept' Micro-plate EtA K002375 Opiates 0piates Intercept" Micro-plate EIA K981341 Phencyclidine PCP Inte… | 2001 |
| * | K981341 | STC Opiates Micro-Plate Eia (Orasure Application)Summary page 2…ids Cannabinoids Intercept' Micro-plate EtA K002375 Opiates 0piates Intercept" Micro-plate EIA K981341 Phencyclidine PCP Intercept' Micro-plate EIA K000399 Product Com… | 1998 |
| * | K000399 | STC PCP Intercept Micro-Plate Eia, Model 11541Summary page 2…0piates Intercept" Micro-plate EIA K981341 Phencyclidine PCP Intercept' Micro-plate EIA K000399 Product Comparison to Predicate Device Device Subject Device… | 2000 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 13.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K171403 (Premier Biotech, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K992918.
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. 2012, this device’s year, is highlighted.
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?
The Oratectt Oral fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocainie (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect®4 tests detect these drugs at the cutoff concentration listed below. Oratecto' Oral Fluid Drug Screen Device d-Amphetamine — 50 ng/mL Oratecto Oral Fluid Drug Screen Device…
Read the full statement (260 words)
The Oratectt Oral fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocainie (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect®4 tests detect these drugs at the cutoff concentration listed below.
Oratecto' Oral Fluid Drug Screen Device d-Amphetamine — 50 ng/mL
Oratecto Oral Fluid Drug Screen Device d-Methamphetamine — 50 ng/mL
Oratect' Oral Fluid Drug Screen Device Delta-9-Tetrahydrocannabinol — 40 ng/mL
Oratect® Oral Fluid Drug Screen Device Cocaine — 20 ng/mL
Odratect'5 Oral Fluid Drug Screen Device Morphine — 40 nglmL
Oratectr Oral Fluid Drug Screen Device Phencyclidine — 10 ng/mL
These products are for in vitro diagnostic use and intended for prescription point of care use.
The Oratect" Oral Fluid Drug Screen Device provides only preliminary drug test results. A more specific alternative method must be used in order to obtain a confirmed analytical result. Liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Samples for confirmatory testing should be collected with the Oratect" Oral Fluid Collection Tube (50 ml, polypropylene tube) provided. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended td be used in monitoring drug levels.
OratectCheckTm Oral Fluid Controls (Negative and Positive controls of the analytes) are available but not supplied with the Oratecta Oral Fluid Drug Screen Devices. The OratectCheck T M Oral Fluid Controls are used as quality control materials with Oratect® Oral Fluid Drug Screen Devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103227: Oratect Oral Fluid Drug Screen Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103227
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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