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.

Device Description

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 test principle is a competitive lateral flow immunochromatographic assay. The presence of analyte will produce a negative signal.

AI/ML Overview

Acceptance Criteria and Device Performance for Oratect® Oral Fluid Drug Screen Devices

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the provided document. However, the document consistently uses "Accuracy results against reference method >90%" as the performance metric for the subject device and "Accuracy results against reference method >89%" for the predicate. For the purpose of this summary, we will infer the acceptance criterion to be >90% accuracy against a reference method.

The reported device performance based on the "Accuracy" row in the comparison table is also >90% against reference method.

Characteristic	Acceptance Criteria (Inferred)	Reported Device Performance
Accuracy (against reference method)	>90%	>90%
Precision	Not explicitly stated, but predicate's <10% imprecision is noted. For the subject device, "overall precision was above 90%"	"overall precision was above 90%"
Cross-reactants and Interference compounds	Not explicitly stated, but "very specific antibodies" and lists in package insert are noted.	"very specific antibodies for their respective test. Only a limited number of structure related chemicals cross react with the tests."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "analytical performance validation studies, precision site studies and in method comparison studies".

Sample Size: The document does not explicitly state the total sample size used for the test set in the "method comparison studies." It mentions "three (3) Point of Care (POC) sites" for the precision study, but not the number of samples at each site or for the overall accuracy study.
Data Provenance: The data provenance is not explicitly stated (e.g., country of origin, specific demographics). The studies are referred to as "analytical" and "clinical" performance tests, implying human samples were involved. It is likely retrospective data collected for validation, as no prospective clinical trial details are provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not provide details on the number of experts or their qualifications used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided text. The study primarily focuses on comparing the subject device's performance against reference laboratory methods (LC/MS or GC/MS) and its predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The device itself, the "Oratect® Oral Fluid Drug Screen Device," is a standalone immunoassay device. The performance described (accuracy, precision, specificity) is inherently its standalone, algorithm-only (or device-only) performance, as it produces a visually interpreted result without human-in-the-loop assistance beyond the interpretation of the test lines.

7. Type of Ground Truth Used

The ground truth used for the comparison studies was established by "LC/MS or GC/MS reference test method." These are highly specific and quantitative laboratory methods considered the definitive gold standard for drug detection.

8. Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. Immunoassay devices like the Oratect® generally do not involve machine learning algorithms that require a distinct training set in the typical sense. Their performance is validated through analytical and clinical studies as described.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a "training set" in the context of machine learning, there is no information on how a ground truth for such a set was established. The performance validation relies on comparing the device's results to established reference methods (LC/MS or GC/MS) for individual samples.

Summary

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K103227

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 orProprietaryName(s):	Oratect® Oral Fluid Drug ScreenDevice	OratectCheck™ Oral FluidControls
Common orUsual Name:	Immunochromatographic test forthe qualitative detection of drugs inoral fluid (human saliva)	Drug Specific ControlMaterials to monitor andvalidate the qualitativeperformance 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)
ProductClassification	Class II	Class I
ClassificationName:	Lateral Flow Immunoassay,Amphetamine, Cocaine,Methamphetamine, Cannabinoids,Opiates and PhencyclidineSee Details Below	Drug Mixture ControlMaterials

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Descriptions	Title and CFRPart	ReviewPanel	RegulationNumber	ProductCode
d-Amphetamines Test Systems(AM)	Title 21 Part 862Clinical	ClinicalToxicology	862.3100	DKZ
Delta-9-Tetrahydrocannabinol(TH)	Chemistry andClinical	TestSystems	862.3870	LDJ
Cocaine Test Systems (CO)	Toxicology		863.3250	DIO
d-Methamphetamines TestSystems (ME)			862.3610	DJC
Opiates Test Systems (OP)			862.3650	DJG
Phencyclidine Test Systems (PC)			862.3100	LCM
OratectCheck™ Saliva/OralFluid Controls (Positive andNegative)	Title 21 Part 862ClinicalToxicologycontrol 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	PredicateDevice 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

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DeviceCharacteristics	Subject Device(BMC Oratect® Oral Fluid DrugScreen Device)	Predicate Devices(OraSure Intercept® Micro-plateElAs)	SubstantiallyEquivalent
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 thequalitative detection of drug analytes inoral fluid (human saliva).For In Vitro Diagnostic Use	Preliminary Drug screening test forthe qualitative detection of druganalytes in oral fluid (humansaliva)For In Vitro Diagnostic Use	Yes
Test Principle/Methodology	Specific non radioisotopeimmunoassay. The assay of smalldrugs of abuse molecules are based onthe competitive immunoassaymethodology, the presence of analytewill produce a negative signal.Competitive lateral flowimmunochromato-graphic assay	Specific non radioisotope -immunoassay. The assay of smalldrugs of abuse molecules are basedon the competitive immunoassaymethodology, the presence ofanalyte will produce a negativesignal.Competitive Enzyme-labeledimmunoassay	Yes
Assay Cut-off-Values	Preset cut-off values used todifferentiate a positive sample from anegative sample.Oratect® Oral Fluid Drug ScreenDevices use the cut-off valuesestablished by SAMHSA except forCannabinoids. The THC testsensitivity limitation is 40 ng/mL.	Preset cut-off values used todifferentiate a positive sample froma negative sample.OraSure Intercept® Micro-plateEIA system sets up a cut-off valuelevel based on the LOD = AO-3 SD	Yes
Assay Conditions	Tests performed at room temperatureand visually interpreted.Oratect® Oral Fluid Drug ScreenDevices are a point of care (POC) testwhich can be performed in less thanfifteen (15) minutes test time.	Tests performed at roomtemperature and utilizinginstrument interpretation.OraSure Intercept® Micro-plateEIA system test require laboratoryinstrumentation, multiple steps andup to ninety (90) minutes test time.	Yes
Reference TestMethod	For a quantitative result or for aconfirmation of a presumptive positiveresult obtained by the Oratect® OralFluid Drug Screen Device, a morespecific alternative confirmatorymethod such as LC/MS/MS must be	A more specific alternativechemical method should be used inorder to obtain a confirmedanalytical result. Gaschromatography/mass spectrometry(GC/MS) is the preferred	Yes.
DeviceCharacteristics	Subject Device(BMC Oratect® Oral Fluid Drug ScreenDevice)	Predicate Devices(OraSure Intercept® Micro-plate EIAs)	SubstantiallyEquivalent
Accuracy	Accuracy results against referencemethod >90%	Accuracy results against referencemethod >89%	Yes
Precision	Oratect® Oral Fluid Drug Screen Deviceswere evaluated at three (3) Point of Care(POC) sites and the overall precision wasabove 90%	OraSure Intercept® Micro-plate EIAsystemTests are an instrument dependentmethod and the assay imprecision wasless than 10%.	Yes
Cross reactantsandInterferencecompounds	Oratect® Oral Fluid Drug Screen Devicesuse very specific antibodies for theirrespective test. Only a limited number ofstructure related chemicals cross reactwith the tests. A list of cross reactantsand interference compounds are presentedin the product package insert. Thepackage insert also includes a list of foodingredients.	OraSure Intercept® Micro-plate EIAsystemDevices use very specific antibodiesfor their respective test. Only alimited number of structure relatedchemicals cross react with the tests. Alist of cross reactants and interferencecompounds are presented in theproduct package insert.	Yes
Test ResultInterpretation	Clinical consideration and professionaljudgment should be applied to any drugsof abuse test result, particularly when apreliminary, positive result is observed.	Clinical consideration and professionaljudgment should be applied to anydrugs of abuse test result, particularlywhen a preliminary, positive result isobserved.	Yes
Testing Site	Point-of Care	Laboratory	No

and and the comments of the comments of

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:

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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).

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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

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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

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.

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

Regulation Number and Section

§ 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).