The RapidFRET Oral Fluid Assay for Cocaine is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for cocaine at 20 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay is calibrated with Cocaine and provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.

The RapidFRET Oral Fluid Cocaine Calibrator Set and RapidFRET Oral Fluid Cocaine Control Set are intended for use with the RapidFRET Oral Fluid Assay for Cocaine and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.

Device Description

The RapidFRET Oral Fluid Assay for Cocaine is an In Vitro Diagnostic competitive immunoassay used to detect cocaine in human oral fluid. This is a ready-to-use homogenous system that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the RapidFRET Oral Fluid Assay for Cocaine, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision	Consistent and accurate results across multiple runs and reagent lots, especially near the cutoff concentration.	Spiked Samples (0% to 200% of cutoff, n=180 per concentration):- 0%, 25%, 50% of cutoff (0, 5, 10 ng/mL): 100% Negative (0% Positive)- 75% of cutoff (15 ng/mL): 99% Negative (1% Positive)- 100% of cutoff (20 ng/mL): 52% Negative, 48% Positive- 125% of cutoff (25 ng/mL): 5% Negative, 95% Positive- 150%, 175%, 200% of cutoff (30, 35, 40 ng/mL): 100% Positive (0% Negative)Conclusion: Analytical sensitivity is between 75% and 125% of cutoff, with expected results achieved at 97% frequency within this range.
Accuracy / Correlation with MS Quantitation	High agreement with confirmatory methods (GC/MS or LC/MS/MS) for both positive and negative samples.	Clinical Samples (n=294):- Low Negative (<10 ng/mL by MS): 226 RapidFRET NEG, 1 RapidFRET POS (Potential cross-reactivity with cinnamoyl cocaine, cocaine at 10ng/mL equivalent, or HMMC).- Near Cutoff Negative (10 - 20 ng/mL by MS): 5 RapidFRET NEG, 2 RapidFRET POS.- Near Cutoff Positive (20 - 30 ng/mL by MS): 0 RapidFRET NEG, 5 RapidFRET POS.- High Positive (>30 ng/mL by MS): 0 RapidFRET NEG, 55 RapidFRET POS.Conclusion: Accurate >99% of the time in neat oral fluid samples.
Cross-Reactivity & Analytical Specificity	Limited and identified cross-reactivity with structurally similar compounds, and no significant interference from common substances, foods, or dental products.	Structurally Related Compounds (171 compounds screened, 13 identified):- Benzoylecgonine: 18 ng/mL (111% cross-reactivity)- Cocaethylene: 15 ng/mL (133% cross-reactivity)- Cinnamoylcocaine: 224 ng/mL (8.2% cross-reactivity)- Others: Chlorpromazine, Clomipramine, Cyclobenzaprine, Ecgonine, Ecgonine methyl ester, Imipramine, Isoxsuprine (HMMC), Norcocaine, Perphenazine, Thioridazine, Trifluoperazine showed cross-reactivity below 30,000 ng/mL (0.1% to 2.4%).Common Substances: All tested compounds (HSA, ethanol, baking soda, blood, etc.), pH variations (5-9), and various mouth/food products (mouthwash, cough syrup, cranberry juice, etc.) showed expected NEG results with 10 ng/mL cocaine and POS results with 30 ng/mL cocaine (i.e., no significant interference at concentrations tested).

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

Precision and Analytical Sensitivity Test Set: For precision, 180 samples were tested for each concentration level (0%, 25%, 50%, 75%, 100%, 125%, 150%, 175%, 200% of cutoff). This involved triplicate samples per run, 4 times daily for 5 days using 3 independent lots of reagent.
Correlation with MS Quantitation Test Set: 294 samples were collected.
Data Provenance:
- Precision and Analytical Sensitivity: "Negative oral fluid pools were spiked with cocaine..." This suggests a controlled laboratory setting, likely in the US where the company is based.
- Correlation with MS Quantitation: "Neat oral fluid was collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for opiates." This implies prospective collection from human subjects, but the country of origin is not explicitly stated. Given the submission to the FDA, it's highly probable the study was conducted in the US.
- Cross Reactivity and Analytical Specificity: Compound library testing and common substance/food testing were conducted in a laboratory setting.

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

Precision and Analytical Sensitivity: For this study, the ground truth was established by spiking known concentrations of cocaine into negative oral fluid. No independent experts were explicitly mentioned for determining the "ground truth" for the spiked samples, as the concentrations were precisely controlled.
Correlation with MS Quantitation: The ground truth was established by confirmatory testing using GC/MS or LC/MS/MS. While these are highly accurate analytical methods, the text does not specify the number or qualifications of experts performing or interpreting these confirmatory tests. It's standard practice that such analyses are performed by qualified laboratory personnel.
Cross Reactivity and Analytical Specificity: The ground truth for cross-reactivity studies was based on known concentrations of the spiked compounds and their expected interaction with the assay, verified by the assay itself relative to the cutoff. For common substances, the ground truth was the known presence/absence of cocaine spikes and the expectation of no interference from the common substance. No external experts for ground truth establishment are explicitly stated beyond the analytical methods.

4. Adjudication Method for the Test Set

The provided text does not describe an explicit adjudication method for discrepant results, such as 2+1 or 3+1. For the correlation study, samples were "sent for confirmatory testing (GC/MS or LC/MS/MS)" after initial screening. This suggests that the confirmatory method served as the de-facto gold standard to resolve any initial screening discrepancies, rather than an expert panel adjudication process from multiple readers/interpreters of the device's results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not described in this document. This device is an in-vitro diagnostic (IVD) assay where the output is a qualitative (positive/negative) result from an automated instrument, not an image or data requiring human interpretation for diagnosis in the same way an AI for medical imaging would. The "human-in-the-loop" aspect here refers to a lab technician performing the test and interpreting the instrument's output based on established cutoffs.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Device Was Done

Yes, the studies reported are standalone performance studies of the RapidFRET Oral Fluid Assay for Cocaine. The device is a "homogeneous time-resolved fluorescence assay" designed for use on an "Integrated Workstation." The performance data (precision, accuracy, cross-reactivity) refer to the analytical performance of the assay system itself, providing a qualitative (positive/negative) result directly, without requiring human interpretation of complex patterns or classifications beyond reading the instrument's output against the defined cutoff. The "human-in-the-loop" here is limited to sample collection, loading, and result reporting, rather than diagnostic interpretation.

7. The Type of Ground Truth Used

Precision and Analytical Sensitivity: Spiked known concentrations of cocaine.
Correlation with MS Quantitation: Confirmatory analytical methods (GC/MS or LC/MS/MS).
Cross Reactivity and Analytical Specificity: Known concentrations of spiked compounds and their expected behavior (presence/absence of cocaine for the interference studies).

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set." This is common for this type of IVD device where development often involves iterative optimization and validation across various sample types and spike levels, rather than a distinct "training set" and "test set" in the context of machine learning. The studies described are more akin to validation studies demonstrating the device's performance characteristics.

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

Since a distinct "training set" is not detailed, the method for establishing ground truth for training is not provided. However, generally, for the development of such assays, manufacturers would leverage:

Well-characterized samples: Including known positive and negative samples, and samples spiked with varying concentrations of the analyte and potential interferents.
Reference methods: Using established gold-standard analytical techniques (like GC/MS or LC/MS/MS) to confirm analyte concentrations in samples used for assay development and optimization.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24, 2015

BIOPHOR DIAGNOSTICS, INC. NATHANIEL BUTLIN VICE PRESIDENT 1201 DOUGLAS AVE REDWOOD CITY CA 94063

Re: K142129

Trade/Device Name: RapidFRET Oral Fluid Assay for Cocaine. RapidFRET Oral Fluid Cocaine Calibrator Set. RapidFRET Oral Fluid Cocaine Control Set Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO, DLJ, DIF Dated: July 1, 2015 Received: July 6, 2015

Dear Nathaniel Butlin:

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 approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, 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 not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142129

Device Name

RapidFRET Oral Fluid Assay for Cocaine RapidFRET Oral Fluid Cocaine Calibrator Set RapidFRET Oral Fluid Cocaine Control Set

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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510(k) Summary for the RapidFRET Oral Fluid Assay for Cocaine

Preparation Date: July 23, 2015

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is: K142129

807.92(a)(1): Contact Information

Name:	Biophor Diagnostics, Inc.
Address:	1201 Douglas Avenue
	Redwood City, CA 94063

Contact: Nathaniel G. Butlin, Ph.D.
Phone: 650-367-4954 Fax: 650-364-4985

807.92(a)(2): Device Name, Common Name and Classification

RapidFRET Oral Fluid Assay for Cocaine (Cocaine Test System) RapidFRET Oral Fluid Cocaine Calibrator Set (Clinical Toxicology Calibrator) RapidFRET Oral Fluid Cocaine Control Set (Drug Mixture Control Materials)

Product	Code	Class	RegulationSection	Panel
RapidFRET Oral Fluid Assay for Cocaine	DIO	II	862.3250	91 - Toxicology
RapidFRET Oral Fluid Cocaine Calibrator Set	DLJ	II	862.3200	91 - Toxicology
RapidFRET Oral Fluid Cocaine Control Set	DIF	I, Reserved	862.3280	91 - Toxicology

807.92(a)(3): Identification of Legally Marketed Predicate Devices

CEDIA® Cocaine OFT Assay (K101742) marketed by Microgenics Corporation, Thermo Fisher Scientific Clinical Diagnostic Division.

807.92(a)(4): Device Description

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acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy.

807.92(a)(5): Intended Use

The RapidFRET Oral Fluid Cocaine Calibrator Set and RapidFRET Oral Fluid Cocaine Control Set are intended for use with the RapidFRET Oral Fluid Assay for Cocaine and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.

	Candidate Device(RapidFRET COC)	Predicate Device(Microgenics COC, K101742)
Indications forUse	Qualitative determination of cocaine inhuman oral fluid in clinical setting.	Qualitative determination of cocaine inhuman oral fluid in clinical setting.
Methodology	Competitive homogeneousimmunoassay.	Competitive homogeneousimmunoassay.
KitComponents	1 Drug specific antibody reagent in liquid,ready to use format.1 Drug conjugate reagent in liquid, readyto use format.	1 Drug specific antibody reagent(marketed in combination as a lyophilizedreagent and reconstitution buffer).1 Drug conjugate reagent (marketed incombination as a lyophilized reagent andreconstitution buffer).
PerformanceCharacteristics	Precision, accuracy, crossreacting/interfering studies demonstrateequivalence to the predicate device.	Precision, accuracy, crossreacting/interfering studies are similar tothe RapidFRET Oral Fluid Assay forCocaine.
Safety and	Demonstrated in bench testing and	Demonstrated in bench testing and

807.92(a)(6): Technological Similarities and Differences to the Predicate

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	Candidate Device(RapidFRET COC)	Predicate Device(Microgenics COC, K101742)
Effectiveness	described in PI, equivalent to predicate.	described in PI.
Neat Oral FluidCutoff Level	20 ng/mL neat oral fluid.	15 ng/mL neat oral fluid using a 5 ng/mLcutoff calibrator to account for sampledilution by collection device.
Platform	RapidFRET Integrated Workstationavailable exclusively from BiophorDiagnostics, Inc.	MGC240 analyzer
SampleCollection	Neat oral fluid is collected with theRapidEASE Oral Fluid Collector via directexpectoration. No diluent is used andsample is stored in glass sample tubewith inert screw cap.	Oral fluid is collected with the Oral-EzeSaliva Collection System. This device usesan absorbent swab and diluent. Sample isstored in plastic tube with snap cap.
Principle andProcedure	Drugs in the oral fluid sample competewith the drug conjugate donorfluorophore for a fixed number of bindingsites on the individual drug antibodyacceptor reagents. When acceptor anddonor fluorophores are brought intoclose proximity, through the bindingevent, fluorescent energy transfer ismeasured.The amount of drug in the specimensample is inversely proportional to theassay signal as measured by timeresolved fluorescence.	The assay is based on the sampleanalytes competing with analyteconjugates to one inactive fragment of ß-galactosidase for antibody binding sites.The amount of drug in the specimen isproportional to the assay signal asmeasured by absorbance.
Controls andCalibratorLevels	Calibrators are available at effectiveconcentrations of 0 ng/mL and 20 ng/mL.Controls are available at effectiveconcentrations of 10 ng/mL and 30ng/mL.	Calibrators are available at 0 ng/mL, 5ng/mL, and 50 ng/mL. Controls areavailable at additional levels.

807.92(b)(1): Brief Description of Study Data:

A series of studies were performed that evaluated the device performance characteristics including precision and analytical sensitivity, correlation with GC/MS and LC/MS/MS, cross reactivity, and analytical specificity that are summarized below.

Precision and Analytical Sensitivity

One lot of RapidFRET Oral Fluid Assay for Cocaine was used to verify precision, four times daily, triplicate samples per run for 5 days using 3 independent lots of reagent. Negative oral fluid pools were spiked with cocaine at 0%, 25%, 50%, 75%, 100%, 125%, 150%, 175% and 200% of the cutoff level corresponding to approximately 0, 5, 10, 15, 20, 25, 30, 35 and 40

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Summary Precision Data for All Lots
	0%	25%	50%	75%	100%	125%	150%	175%	200%
POS	0	0	0	1	86	171	180	180	180
NEG	180	180	180	179	94	9	0	0	0
N	180	180	180	180	180	180	180	180	180

ng/mL. The aggregate data is summarized in the table below:

Summary Precision Data for All Lots: Percent Agreement
	0%	25%	50%	75%	100%	125%	150%	175%	200%
POS	0%	0%	0%	1%	48%	95%	100%	100%	100%
NEG	100%	100%	100%	99%	52%	5%	0%	0%	0%
N	180	180	180	180	180	180	180	180	180

The data indicate that the analytical sensitivity is between 75% and 125% of cutoff, and expected results were achieved at a 97% frequency within this range.

Correlation with MS Quantitation

Neat oral fluid was collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for opiates. The samples (n=294) were randomized and blinded to the instrument operator and assayed using RapidFRET COC reagents. Following screening, positive and negative samples were sent for confirmatory testing. The summarized data are shown below.

n = 294	Low Negative(<10 ng/mL)	Near Cutoff Negative(10 - 20 ng/mL)	Near Cutoff Positive(20 - 30 ng/mL)	High Positive(>30 ng/mL)
RapidFRETPOS	1§	2§	5	55
RapidFRETNEG	226	5	0	0

ී One sample contained cinnamoyl cocaine at 388 ng/mL; a second sample contained cocaine, and cinnamoyl cocaine at 10 ng/mL equivalent concentration; a third sample contained high levels of hydroxymethcathinone (HMMC), a major metabolite of methylone, which shares structural similarities to isoxsuprine, a known cross-reactant."

The data indicate that the RapidFRET Oral Fluid Assay for Cocaine was accurate >99% of the time in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector.

Cross Reactivity and Analytical Specificity

A compound library of approximately 171 different structurally related and unrelated compounds including metabolites, OTC and prescription medications and drugs of abuse was used to evaluate the device cross reactivity and specificity. Compounds were spiked at 30,000 ng/mL into neat oral fluid pool aliquots with 0 ng/mL and 30 ng/mL of cocaine, processed with the RapidEASE Collector, and tested with the RapidFRET COC assay. Those compounds that gave an unexpected result were further titrated to determine the concentration at which the cross-reacting compound yielded a result approximately

4 Kamata et al., Japanese Journal of Forensic Science and Technology, (2007), 12(1):97-106. Ellefsen, Kayla N., et al., Forensic Toxicology (2015): 1-11.

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equivalent to the cutoff. Thirteen (13) structurally related compounds were determined to
cross-react below 30,000 ng/mL in the absence of cocaine. These are noted in the labeling.

Compound	Concentration (ng/mL)	Cross-Reactivity (%)
Benzoylecgonine	18	111%
Chlorpromazine	17,705	0.1%
Cinnamoylcocaine	224	8.2%
Clomipramine	13,824	0.1%
Cocaethylene	15	133%
Cocaine	20.5	98%
Cyclobenzaprine	18,218	0.1%
Ecgonine	3,384	0.6%
Ecgonine methyl ester	3,365	0.6%
Imipramine	19,847	0.1%
Isoxsuprine*	846	2.4%
Norcocaine	1,730	1.2%
Perphenazine	5,959	0.3%
Thioridazine	23,723	0.1%
Trifluoperazine	21,831	0.1%

*Hydroxymethoxymethcathinone (HMMC), a major methylone, shares structural similarities to isoxsuprine and has been shown to cause interference.

A second study evaluated common substances such as foods and dental products as well as pH variations. HSA, ethanol, baking soda, whole blood, hemoglobin, hydrogen peroxide, sodium chloride, cholesterol, denture adhesive, ascorbic acid, bilirubin, lgA, lgG and IgM were spiked into neat oral fluid pool aliquots that contained either 10 ng/mL of cocaine. Neat oral fluid pool was titrated to pH values of 5, 6, 7, 8 and 9, spiked with cocaine to 10 ng/mL or 30 ng/mL and assayed with the RapidFRET COC Assay. The effects of antiseptic mouthwash, cough syrup, cranberry juice, orange juice, tooth paste, chewing tobacco, cigarettes, chewing gum, hard candy, teeth whitening strips, cola, water, antacid, coffee and tea were evaluated by asking volunteers to use a specific item and provide an oral fluid sample. These samples were then spiked with cocaine to 10 ng/mL or 30 ng/mL, processed with a RapidEASE Collector and assayed with the RapidFRET COC device. All compounds at the listed concentrations gave a NEG result when spiked with 10 ng/mL cocaine and a POS result when spike with 30 ng/mL cocaine.

807.92(b)(3): Conclusions

The RapidFRET Oral Fluid Assay for Cocaine including the RapidFRET Oral Fluid Negative and Cutoff Calibrators, the RapidFRET Oral Fluid Negative and Positive Controls and the RapidEASE Oral Fluid Collector were determined to be safe and effective for their intended use.

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).