(527 days)
No
The device is described as a lateral flow immunoassay, which is a traditional biochemical detection method. There is no mention of AI, ML, or any computational analysis of results.
No
This device is for in vitro diagnostic use, specifically for qualitative detection of drugs in oral fluid. It provides preliminary test results and is not used for treatment or therapy.
Yes
The document explicitly states, "These products are for in vitro diagnostic use." It also describes the device as a "one-step lateral flow immunoassay device for the qualitative detection" of specific drugs in human oral fluid, which is a diagnostic function.
No
The device is described as a "one-step lateral flow immunoassay device," which is a physical hardware component used for testing. The summary focuses on the performance of this physical device and does not mention any software component as the primary medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "These products are for in vitro diagnostic use".
- Nature of the Test: The device performs a "qualitative detection" of specific substances (drugs) in a biological sample (human oral fluid). This is a core characteristic of in vitro diagnostics, which are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Point of Care Use: The intended use is "prescription point of care use," which is a common setting for IVD devices used for rapid testing.
- Use of Controls: The mention of "OratectCheck™ Oral Fluid Controls" being used as "quality control materials with Oratect® Oral Fluid Drug Screen Devices" further reinforces its nature as a diagnostic test requiring quality assurance.
N/A
Intended Use / Indications for Use
The Oratect 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), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect tests detect these drugs at the cutoff concentration listed below.
Test: Oratect® Oral Fluid Drug Screen Device d-Amphetamine, Cutoff: 50 ng/mL
Test: Oratect® Oral Fluid Drug Screen Device d-Methamphetamine, Cutoff: 50 ng/mL
Test: Oratect® Oral Fluid Drug Screen Device Delta-9-Tetrahydrocannabinol, Cutoff: 40 ng/mL
Test: Oratect® Oral Fluid Drug Screen Device Cocaine, Cutoff: 20 ng/mL
Test: Oratect® Oral Fluid Drug Screen Device Morphine, Cutoff: 40 ng/mL
Test: Oratect® Oral Fluid Drug Screen Device Phencyclidine, Cutoff: 10 ng/mL
These products are for in vitro diagnostic use and intended for prescription point of care use.
The Orated® 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 to be used in monitoring drug levels.
OratectCheck™ Oral Fluid Controls (Negative and Positive controls of the analytes) are available but not supplied with the Oratect Oral Fluid Drug Screen Devices. The OratectCheck™ Oral Fluid Controls are used as quality control materials with Oratect® Oral Fluid Drug Screen Devices.
Product codes
DKZ, LDJ, DIO, DJC, DJG, LCM, DIF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Fluid (human saliva)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription point of care use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the BMC Oratect® Oral Fluid Drug Screen Devices was determined in analytical performance validation studies, precision site studies and in method comparison studies comparing the BMC Oratect® Oral Fluid Drug Screen Devices against LC/MS or GC/MS reference test method.
The performance characteristics of the BMC Oratect® Oral Fluid Drug Screen Devices were based on evaluations by the following analytical and clinical performance tests:
1.0 Test method comparison (pipette adding vs. oral swab)
2.0 Optimal Read Time Window
3.0 Specificity/Cross Reactivity
4.0 Interferences and Effect of Food Interference
5.0 Product Stability
6.0 Precision Site Study
7.0 Comparison Study
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy results against reference method >90%
Oratect® Oral Fluid Drug Screen Devices were evaluated at three (3) Point of Care (POC) sites and the overall precision was above 90%
Predicate Device(s)
K992918, K001197, K001197, K002375, K981341, K000399
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
APR 1 1 2012
510(k) Summary (as required by section 807.92(c)
Traditional 510(k) Premarket Notification Oratect® Oral Fluid Drug Screen Devices
Date Prepared: Date Updated:
10/29/10 02/01/12
510 (K) Owner
Raphael Wong Branan Medical Corp. 140 Technology Drive Irvine, CA 92618
Phone: (949)-598-7166 Fax: (949)-598-7167 Email: raphael@brananmedical.com
Correspondent
Huiying Wang, Ph.D Director of Research & Development Branan Medical Corporation
Phone (949)-598-7166, ext. 135 (949)-727-2131 Fax: Email: hwang@brananmedical.com
Device Name
| Trade or
Proprietary
Name(s): | Oratect® Oral Fluid Drug Screen
Device | OratectCheck™ Oral Fluid
Controls |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Common or
Usual Name: | Immunochromatographic test for
the qualitative detection of drugs in
oral fluid (human saliva) | Drug Specific Control
Materials to monitor and
validate the qualitative
performance of the device. |
| | d-Amphetamines Test Systems (AM) | Positive Control |
| | Delta-9-Tetrahydrocannabinol (TH) | Negative Control |
| | Cocaine Test Systems (CO) | |
| | d-Methamphetamines Test Systems
(ME) | |
| | Opiates Test Systems (OP) | |
| | Phencyclidine Test Systems (PC) | |
| Product
Classification | Class II | Class I |
| Classification
Name: | Lateral Flow Immunoassay,
Amphetamine, Cocaine,
Methamphetamine, Cannabinoids,
Opiates and Phencyclidine
See Details Below | Drug Mixture Control
Materials |
1
| Descriptions | Title and CFR
Part | Review
Panel | Regulation
Number | Product
Code |
|------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------|----------------------|-----------------|
| d-Amphetamines Test Systems
(AM) | Title 21 Part 862
Clinical | Clinical
Toxicology | 862.3100 | DKZ |
| Delta-9-Tetrahydrocannabinol
(TH) | Chemistry and
Clinical | Test
Systems | 862.3870 | LDJ |
| Cocaine Test Systems (CO) | Toxicology | | 863.3250 | DIO |
| d-Methamphetamines Test
Systems (ME) | | | 862.3610 | DJC |
| Opiates Test Systems (OP) | | | 862.3650 | DJG |
| Phencyclidine Test Systems (PC) | | | 862.3100 | LCM |
| OratectCheck™ Saliva/Oral
Fluid Controls (Positive and
Negative) | Title 21 Part 862
Clinical
Toxicology
control Material | Toxicology | 862.3280 | DIF |
Substantial Equivalency -
The Oratect® Oral Fluid Drug Screen Device Test is substantially equivalent to the following Intercept® Micro-plate EIAs manufactured by OraSure Technologies Inc. (formerly known as STC Technologies, Inc) for its general intended use.
| Device Description | Predicate Device Name | Predicate
Device 510(k) # |
|--------------------|-------------------------------------------------|------------------------------|
| Amphetamine | Amphetamine-Specific Intercept® Micro-plate EIA | K992918 |
| Cocaine | Cocaine Metabolites Intercept® Micro-plate EIA | K001197 |
| Methamphetamine | Methamphetamine Intercept® Micro-plate EIA | K001197 |
| Cannabinoids | Cannabinoids Intercept® Micro-plate EIA | K002375 |
| Opiates | Opiates Intercept® Micro-plate EIA | K981341 |
| Phencyclidine | PCP Intercept® Micro-plate EIA | K000399 |
2
| Device
Characteristics | Subject Device
(BMC Oratect® Oral Fluid Drug
Screen Device) | Predicate Devices
(OraSure Intercept® Micro-plate
ElAs) | Substantially
Equivalent |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Specimen Type | Oral Fluid (human saliva) | Oral Fluid (human saliva) | Yes |
| Drug Analytes | d-Amphetamine, Cocaine,
d-Methamphetamine, Cannabinoids,
Opiates, and PCP | d-Amphetamine, Cocaine,
d-Methamphetamine,
Cannabinoids, Opiates, and PCP | Yes |
| Intended Use | Preliminary Drug screening test for the
qualitative detection of drug analytes in
oral fluid (human saliva).
For In Vitro Diagnostic Use | Preliminary Drug screening test for
the qualitative detection of drug
analytes in oral fluid (human
saliva)
For In Vitro Diagnostic Use | Yes |
| Test Principle/
Methodology | Specific non radioisotope
immunoassay. The assay of small
drugs of abuse molecules are based on
the competitive immunoassay
methodology, the presence of analyte
will produce a negative signal.
Competitive lateral flow
immunochromato-graphic assay | Specific non radioisotope -
immunoassay. The assay of small
drugs of abuse molecules are based
on the competitive immunoassay
methodology, the presence of
analyte will produce a negative
signal.
Competitive Enzyme-labeled
immunoassay | Yes |
| Assay Cut-off-
Values | Preset cut-off values used to
differentiate a positive sample from a
negative sample.
Oratect® Oral Fluid Drug Screen
Devices use the cut-off values
established by SAMHSA except for
Cannabinoids. The THC test
sensitivity limitation is 40 ng/mL. | Preset cut-off values used to
differentiate a positive sample from
a negative sample.
OraSure Intercept® Micro-plate
EIA system sets up a cut-off value
level based on the LOD = AO-3 SD | Yes |
| Assay Conditions | Tests performed at room temperature
and visually interpreted.
Oratect® Oral Fluid Drug Screen
Devices are a point of care (POC) test
which can be performed in less than
fifteen (15) minutes test time. | Tests performed at room
temperature and utilizing
instrument interpretation.
OraSure Intercept® Micro-plate
EIA system test require laboratory
instrumentation, multiple steps and
up to ninety (90) minutes test time. | Yes |
| Reference Test
Method | For a quantitative result or for a
confirmation of a presumptive positive
result obtained by the Oratect® Oral
Fluid Drug Screen Device, a more
specific alternative confirmatory
method such as LC/MS/MS must be | A more specific alternative
chemical method should be used in
order to obtain a confirmed
analytical result. Gas
chromatography/mass spectrometry
(GC/MS) is the preferred | Yes. |
| Device
Characteristics | Subject Device
(BMC Oratect® Oral Fluid Drug Screen
Device) | Predicate Devices
(OraSure Intercept® Micro-plate EIAs) | Substantially
Equivalent |
| Accuracy | Accuracy results against reference
method >90% | Accuracy results against reference
method >89% | Yes |
| Precision | Oratect® Oral Fluid Drug Screen Devices
were evaluated at three (3) Point of Care
(POC) sites and the overall precision was
above 90% | OraSure Intercept® Micro-plate EIA
system
Tests are an instrument dependent
method and the assay imprecision was
less than 10%. | Yes |
| Cross reactants
and
Interference
compounds | Oratect® Oral Fluid Drug Screen Devices
use very specific antibodies for their
respective test. Only a limited number of
structure related chemicals cross react
with the tests. A list of cross reactants
and interference compounds are presented
in the product package insert. The
package insert also includes a list of food
ingredients. | OraSure Intercept® Micro-plate EIA
system
Devices use very specific antibodies
for their respective test. Only a
limited number of structure related
chemicals cross react with the tests. A
list of cross reactants and interference
compounds are presented in the
product package insert. | Yes |
| Test Result
Interpretation | Clinical consideration and professional
judgment should be applied to any drugs
of abuse test result, particularly when a
preliminary, positive result is observed. | Clinical consideration and professional
judgment should be applied to any
drugs of abuse test result, particularly
when a preliminary, positive result is
observed. | Yes |
| Testing Site | Point-of Care | Laboratory | No |
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Product Comparison to Predicate Device
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Test Summary:
Performance data
The performance of the BMC Oratect® Oral Fluid Drug Screen Devices was determined in analytical performance validation studies, precision site studies and in method comparison studies comparing the BMC Oratect® Oral Fluid Drug Screen Devices against LC/MS or GC/MS reference test method.
The performance characteristics of the BMC Oratect® Oral Fluid Drug Screen Devices were based on evaluations by the following analytical and clinical performance tests:
1.0 Test method comparison (pipette adding vs. oral swab)
2.0 Optimal Read Time Window
3.0 Specificity/Cross Reactivity
4.0 Interferences and Effect of Food Interference
5.0 Product Stability
6.0 Precision Site Study
7.0 Comparison Study
Conclusion:
4
The above substantial equivalence comparison demonstrates that the BMC Oratect® Oral Fluid Drug Screen Devices are as safe and effective and perform as well as or better than the predicate devices.
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of a human form, suggesting the department's focus on health and human well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Branan Medical Corporation Attn: Huiying Wang, Ph.D. Director of Research & Development 140 Technology Drive Suite 400 Irvine, CA 92618
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
APR 1 1 2012
K103227 Re:
Trade Name: Oral Fluid Drug Screen Devices and OratectCheck Oral Fluid Controls Regulation Number: 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Codes: DKZ, DJC, DIO. DJG, LCM, LDJ, DIF Dated: April 09, 2012
Received: April 10, 2012
Dear Dr. Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require with the providents of approval application (PMA). You may, therefore, market the approval of a promancement controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, provisions to the ing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations (1 MF), It may be bacyce to tound in Title 21, Code of Federal Regulations (CFR), Parts attecting your actricisco, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does Flease be advised that FDA b letermination that your device complies with other Ilot illean that I DA has mace a ceteral statutes and regulations administered by other requirements of the Act of any 1 outstant with all the Act's requirements, including, but not Federal agencies: "Tournast comps) 1 CFR Part 807); labeling (21 CFR Parts 801 and immed to: legistration and insting (2) ======================================================================================================================================= 009), medical device reporting (represents as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
$\mathcal{N}$
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
510(k) Number (if known): K103227
Device Name(s): 1. Oratect® Oral Fluid Drug Screen Devices (see table below)
2. OratectCheck™ Oral Fluid Controls
The Oratect 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), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect tests detect these drugs at the cutoff concentration listed below.
| Test | Cutoff |
|---|---|
| Oratect® Oral Fluid Drug Screen Device d-Amphetamine | 50 ng/mL |
| Oratect® 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 |
| Oratect® Oral Fluid Drug Screen Device Morphine | 40 ng/mL |
| Oratect® 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 Orated® 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 to be used in monitoring drug levels.
OratectCheck™ Oral Fluid Controls (Negative and Positive controls of the analytes) are available but not supplied with the Oratect Oral Fluid Drug Screen Devices. The OratectCheck™ Oral Fluid Controls are used as quality control materials with Oratect® Oral Fluid Drug Screen Devices.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Concurrence of C
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K10322