The RapidFRET Oral Fluid Assay for Methamphetamine 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 methamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay 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 Methamine Calibrators and RapidFRET Oral Fluid Methamphetamine Controls are intended for use only with appropriate RapidFRET Oral Fluid Assay products 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 controls are used to monitor laboratory systems, operators, precision. accuracy and assay conditions. For In Vitro Diagnostic Use Only.

Device Description

The RapidFRET Oral Fluid Assay for Methamphetamine is an In Vitro Diagnostic competitive immunoassay used to detect methamphetamine 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

The provided text describes the RapidFRET Oral Fluid Assay for Methamphetamine. Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" through a defined table or specific performance thresholds for sensitivity, specificity, or accuracy that the device must meet. Instead, the performance characteristics are presented as results from various studies, which imply the expected performance for a successful premarket notification. The de facto acceptance criteria appear to be substantial equivalence to the predicate device (Lin-Zhi International, Inc., LZI Oral Fluid Methamphetamine Enzyme Immunoassay (K131652)) and demonstrating acceptable analytical performance.

However, based on the provided data, we can infer some performance expectations and list the reported outcomes:

Performance Characteristic	Inferred Acceptance Criteria / Expectation (based on predicate equivalence and general assay performance)	Reported Device Performance
Analytical Sensitivity (D-Methamphetamine)	Accurate detection near the cutoff concentration (50 ng/mL) with high frequency for levels above cutoff and low frequency for levels below cutoff. Expected to be within 75% and 125% of cutoff.	Within 75% and 125% of cutoff (37.5 ng/mL to 62.5 ng/mL). Achieved 100% frequency of expected results in this range.
Precision	Repeatable and reproducible results across different lots and runs.	Three lots analyzed over 20+ days showed consistent results. At 100% of cutoff (50 ng/mL), 47 positive and 217 negative results out of 264 total were reported (implying some samples at this exact cutoff concentration might be interpreted as negative depending on minor fluctuation around the threshold). All samples at 125%, 150%, 175%, and 200% of cutoff were positive (264/264 P), and all samples at 0%, 25%, 50%, and 75% of cutoff were negative (264/264 N) except for the 100% cutoff samples.
Correlation with MS Quantitation (Accuracy)	High agreement with a gold standard confirmatory method (GC/MS or LC/MS/MS).	Overall Agreement for n=92 samples: - RapidFRET POS / Confirmed POS: - ≥150% Cutoff: 39 - 100-150% Cutoff: 5 - 50-100% Cutoff: 2‡ (These would ideally be negative by the screening cutoff) - <50% Cutoff: 8† (These would ideally be negative by the screening cutoff) - RapidFRET NEG / Confirmed NEG: - <50% Cutoff: 33 - 50-100% Cutoff: 3 (These would ideally be positive by the screening cutoff) - RapidFRET NEG / Confirmed POS: - ≥150% Cutoff: 2 (Misclassified as negative, potentially due to l-methamphetamine or other factors) Note: Specific footnotes detail instances of co-occurring substances (MDMA, methylone, 4-methethylcathinone, l-methamphetamine) that might explain some discrepancies.
Cross-Reactivity/Analytical Specificity	Minimal cross-reactivity with structurally similar compounds below clinically relevant concentrations. No interference from common substances (foods, dental products, pH variations).	Structurally Related Cross-Reactants (No Methamphetamine Added): - Mephentermine (3.3%) - d-Amphetamine (1.4%) - l-Methamphetamine (17%) - And many others (see table for full list including BDB, Phenethylamine, Chloroquine, Fenfluramine, l-Phenylephrine, MBDB (179%), MDA, MDEA, MDMA (40%), 4-MEC, Methylone, PMA, PMMA (57%), Procaine, Ranitidine, Trimethobenzamide). MBDB and PMMA show significant cross-reactivity. MDMA and l-Methamphetamine also show considerable cross-reactivity. Structurally Related Cross-Reactants (with 25 ng/mL Methamphetamine): - d-Ephedrine (0.2%) - l-Amphetamine (0.2%) - Procainamide (0.2%) Common Substances: All tested common substances (foods, dental products, pH variations (5-9)) at specified levels gave a NEG result at 25 ng/mL methamphetamine and a POS result at 75 ng/mL methamphetamine, indicating no interference within this range.

2. Sample Size and Data Provenance

Analytical Sensitivity & Precision:
- Sample size: 264 per concentration level (total 9 concentrations x 264 samples = 2376 test results) for the aggregate data table, across 3 lots and 20+ non-consecutive days. This refers to spiked negative oral fluid samples, not patient samples.
- Data provenance: Not explicitly stated, but based on "negative oral fluid spiked," it is laboratory-generated data.
Correlation with MS Quantitation (Accuracy):
- Sample size: 92 oral fluid samples (from volunteers).
- Data provenance: Retrospective for analysis, but the samples were "collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for methamphetamine." This suggests a prospective collection for this specific study, but then subjected to retrospective analysis with blinding. Country of origin not specified.
Cross-Reactivity and Analytical Specificity:
- Sample size: Not explicitly detailed by number of samples, but involved a "compound library" and various common substances, each spiked into "neat oral fluid pool aliquots."
- Data provenance: Laboratory-generated data using spiked oral fluid.

3. Number of Experts and Qualifications for Ground Truth

For the "Correlation with MS Quantitation" study, the ground truth was established by confirmatory testing using "a more specific alternate chemical method such as GC/MS or LC/MS/MS." These are analytical chemistry techniques, not typically interpreted by "experts" in the human sense (e.g., radiologists). The "experts" here would be the laboratory personnel operating and interpreting the results of the GC/MS or LC/MS/MS, who are typically highly trained analytical chemists or toxicologists. The number and qualifications are not specified in the document.

4. Adjudication Method for the Test Set

For the "Correlation with MS Quantitation" study, the adjudication method was comparison against the results of GC/MS or LC/MS/MS. This is a direct comparison to a gold standard, so no human adjudication (e.g., 2+1, 3+1 consensus reading) of the device's results was described or necessary. The samples were "randomized and blinded to the instrument operator" for the RapidFRET assay.

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

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay; its performance is measured analytically rather than by human readers interpreting images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. Standalone Performance

Yes, a standalone performance study was done. The entire Brief Description of Study Data section (Precision, Analytical Sensitivity, Correlation with MS Quantitation, Cross-Reactivity, Analytical Specificity) describes the performance of the RapidFRET Oral Fluid Assay device itself, without human interpretation or intervention in the diagnostic decision-making process beyond initial sample handling and instrument operation. The device provides a qualitative "positive" or "negative" screen based on its internal cutoff.

7. Type of Ground Truth Used

Analytical True Value / Confirmatory Test Results:
- For Analytical Sensitivity and Precision, the ground truth was the known concentration of d-methamphetamine spiked into negative oral fluid.
- For Correlation with MS Quantitation, the ground truth was established by GC/MS or LC/MS/MS results, considered the gold standard for confirmatory drug testing.
- For Cross-Reactivity and Analytical Specificity, the ground truth was the known composition and concentration of spiked compounds.

8. Sample Size for the Training Set

This device is an immunoassay, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" of an immunoassay is more akin to assay development and optimization to achieve desired sensitivity and specificity, using reagents and chemical principles. Hence, there is no discrete "training set" sample size like a deep learning model would have. The document describes analytical validation studies, not AI model development.

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

As noted above, this concept doesn't directly apply to this type of immunoassay. The development and optimization of the assay (which could be considered analogous to "training") would involve establishing the expected reactivity of the antibodies and drug conjugates, and setting the cutoff calibrator, typically through extensive laboratory experimentation using precisely known concentrations of analytes and interferents.

Summary

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

September 18, 2015

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

Re: K142293

Trade/Device Name: Rapidfret Oral Fluid Assav for Methamphetamine Rapidfret Oral Fluid Methamphetamine Calibrators Rapidfret Oral Fluid Methamphetamine Controls Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: LAF, DLJ, LAS Dated: September 11, 2015 Received: September 14, 2015

Dear Dr. 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) K142293

Device Name

RapidFRET Oral Fluid Assay for Methamphetamine, RapidFRET Oral Fluid Methamphetamine Calibrators, RapidFRET Oral Fluid Methamphetamine Controls

Indications for Use (Describe)

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

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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

September 11, 2015

The assigned 510(k) number is: K142293

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 Methamphetamine (Methamphetamine Test System) RapidFRET Oral Fluid Methamphetamine Calibrators (Drug Specific Calibrator) RapidFRET Oral Fluid Methamphetamine Controls (Drug Specific Control Materials)

Product	Code	Class	RegulationSection	Panel
RapidFRET Oral Fluid Assay for Methamphetamine	LAF	II	862.3610	91 - Toxicology
RapidFRET Oral Fluid Methamphetamine Calibrators	DLJ	II	862.3200	91 - Toxicology
RapidFRET Oral Fluid Methamphetamine Controls	LAS	I	862.3280	91 - Toxicology

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

Lin-Zhi International, Inc., LZI Oral Fluid Methamphetamine Enzyme Immunoassay (K131652).

807.92(a)(4): Device Description

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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 Assay for Methamphetamine 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 Methamphetamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay 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 Methamphetamine Calibrators and RapidFRET Oral Fluid Methamphetamine Controls are intended for use only with appropriate RapidFRET Oral Fluid Assay Products 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 MET)	Predicate Device(Lin-Zhi MET, K131652)
Indications forUse	Qualitative determination ofmethamphetamine in human oral fluid inclinical setting.	Qualitative determination ofmethamphetamine in human oral fluid inclinical 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.	A drug specific antibody reagent (R1) anda drug conjugate reagent (R2).
PerformanceCharacteristics	Precision, accuracy, crossreacting/interfering studies demonstrateequivalence to the predicate device.	Precision, accuracy, crossreacting/interfering studies are similar tothe RapidFRET Oral Fluid Assay forMethamphetamine.
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 MET)	Predicate Device(Lin-Zhi MET, K131652)
Effectiveness	described in PI, equivalent to predicate.	described in PI.
Neat Oral FluidCutoff Level	50 ng/mL neat oral fluid.	50 ng/mL neat oral fluid.
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 LZI OralFluid collector.
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 competition ofdrugs in a sample and drug labeledG6PDH. Drug in the sample binds to thedrug specific antibody leaving G6PDHactive to produce assay signal. If no drugis present in sample, it binds to thelabeled G6PDH enzyme inhibiting activity.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 50 ng/mL.Controls are available at effectiveconcentrations of 25 ng/mL and 75ng/mL.	Calibrators are available at 0 ng/mL, 20ng/mL, 50 ng/mL, 100 ng/mL and 140ng/mL. Controls are available at 37.5ng/mL and 62.5 ng/mL.

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 LC/MS/MS, cross reactivity, and analytical specificity that are summarized below.

Precision and Analytical Sensitivity

Three lots of the RapidFRET Oral Fluid Assay for Methamphetamine were analyzed for a minimum of 20 non-consecutive days. Negative oral fluid was spiked with dmethamphetamine to 0%, 25%, 50%, 75%, 100%, 125%, 175% and 200% of the cutoff level corresponding to approximately 0, 12.5, 25, 37.5, 50, 62.5, 75, 87.5 and 100 ng/mL. Samples were then processed through a RapidEASE Oral Fluid Collector. Three lots of reagents were used to analyze samples on the RapidFRET Integrated Workstation. The

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Summary Precision Data – 3 Lots
	0%	25%	50%	75%	100%	125%	150%	175%	200%
POS	0	0	0	0	47	264	264	264	264
NEG	264	264	264	264	217	0	0	0	0
N	264	264	264	264	264	264	264	264	264

aggregate data is summarized in the tables below:

The data indicate that the analytical sensitivity is between 75% and 125% of cutoff, and expected results were achieved at a 100% frequency.

Correlation with MS Quantitation

Neat oral fluid was collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for methamphetamine. The samples (n=92) were randomized and blinded to the instrument operator and assayed using RapidFRET MET reagents. Following screening, positive and negative samples were sent for confirmatory testing. The summarized data are shown below.

Accuracy Summary Data
Range	< 50% of Cutoff	50% to 100% ofCutoff	100% to 150% ofCutoff	>150% of Cutoff
RapidFRET POS	8+	2‡	5	39
RapidFRET NEG	33	3	0	2*

†Six samples contained MDMA at 241, 1940, 211, 2020, 4310, and 250 ng/mL; a seventh sample contained MDMA at 10 ng/mL, methylone at 47,000 ng/mL and 4-methethylcathinone at 7,240 ng/mL; the eighth sample contained MDMA at 13.6 ng/mL, and methylone at 8,920 ng/mL. +One sample contained MET at 40.4 ng/mL and MDMA at 1,880 ng/mL; a second sample contained MET at 36.8 ng/mL and MDMA at 439 ng/mL. *One sample contained 150 ng/mL I-methamphetamine; a second sample contained 28.4 ng/mL d-methamphetamine and 114 ng/mL l-methamphetamine.

Cross Reactivity and Analytical Specificity

A compound library of 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, 25 ng/mL and 75 ng/mL methamphetamine equivalent, processed with the RapidEASE Collector, and tested with the RapidFRET MET 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 equivalent to the cutoff. Twenty (20) structurally related compounds were determined to cross-react below 30,000 ng/mL in the absence of methamphetamine with 3 cross-reacting below 30,000 ng/mL in the presence of 25 ng/mL methamphetamine.

Structurally Related Cross Reactants
Compound	Cutoff EquivalentConcentration (ng/mL)	Percent Cross-Reactivity
Structurally Related Compounds That Cross React in Neat Oral Fluid Pool with No Added Methamphetamine
(-) Ephedrine	5,100	1.0%

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Biophor Diagnostics, Inc.

Traditional Premarket Notification 510(k) Submission RapidFRET Oral Fluid Assay for Methamphetamine

Structurally Related Cross Reactants
Compound	Cutoff EquivalentConcentration (ng/mL)	Percent Cross-Reactivity
Benzodioxolylbutanamine (BDB)	16,000	0.3%
Phenethylamine	5,700	0.9%
Chloroquine	2,300	2.2%
d-Amphetamine	3,500	1.4%
Fenfluramine	290	17%
I-Methamphetamine	300	17%
I-Phenylephrine	9,400	0.5%
N-methyl-1,3-benzodioxolylbutanamine (MBDB)	28	179%
Methylenedioxyamphetamine (MDA)	12,700	0.4%
Methylenedioxyethamphetamine (MDEA)	1,100	4.5%
Methylenedioxymethamphetamine (MDMA)	126	40%
Mephentermine	1,500	3.3%
4-Methylethcathinone (4-MEC)	4,555	1.1%
Methylone	3,438	1.5%
para-Methoxyamphetamine (PMA)	9,100	0.5%
para-Methoxymethamphetamine (PMMA)	87	57%
Procaine	24,000	0.2%
Ranitidine	8,300	0.6%
Trimethobenzamide	730	6.8%
Structurally Related Compounds That Cross React in Oral Fluid Pool Spiked with 25 ng/mL Methamphetamine
d-Ephedrine	23,000	0.2%
I-Amphetamine	25,000	0.2%
Procainamide	23,000	0.2%

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 25 ng/mL or 75 ng/mL of methamphetamine equivalent. Neat oral fluid pool was titrated to pH values of 5, 6, 7, 8 and 9, spiked with methamphetamine to 25 ng/mL or 75 ng/mL equivalent and assayed with the RapidFRET MET 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 methamphetamine to 25 ng/mL or 75 ng/mL equivalent, processed with RapidEASE Collectors and assayed with the RapidFRET MET device. All compounds at the listed concentrations gave a NEG result when spiked with 25 ng/mL methamphetamine and a POS result when spike with 75 ng/mL methamphetamine.

807.92(b)(3): Conclusions

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

Regulation Number and Section

§ 862.3610 Methamphetamine test system.

(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).