# K103227: Oratect Oral Fluid Drug Screen Devices

- Pathway: 510(k) (Traditional)
- Applicant: Branan Medical Corporation
- Decided: Apr 11, 2012 after 527 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924446 (1992). 7 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992918: STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I, OraSure Technologies, Inc. (2000) Summary page 2.
- K001197: Cocaine Metabolite Intercept Micro-Plate Eia, OraSure Technologies, Inc. (2000)
- K002375: STC Cannabinoids Intercept Micro-Plate Eia, Model 1118I, OraSure Technologies, Inc. (2001) Summary page 2.
- K981341: STC Opiates Micro-Plate Eia (Orasure Application), OraSure Technologies, Inc. (1998) Summary page 2.
- K000399: STC PCP Intercept Micro-Plate Eia, Model 11541, OraSure Technologies, Inc. (2000) Summary page 2.

## Most influential descendants
- K171403: OralTox Oral Fluid Drug Test (2018), 3 descendants of its own
- K181305: OralTox Oral fluid Drug Test (2018), 1 descendant of its own
- K132688: Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZ (2013), 1 descendant of its own
- K253705: Healgen® Accurate Oral Fluid Drug Test (2026), 0 descendants of its own
- K240287: LYHER® Oral fluid Multi-Drug Test Kit (Cube) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K103227
Methodology: https://510kreport.com/methodology