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

K142293 · Biophor Diagnostics, Inc. · LAF · Sep 18, 2015 · Clinical Toxicology

Device Facts

• Record ID: K142293
• Device Name: Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls
• Applicant: Biophor Diagnostics, Inc.
• Product Code: LAF · Clinical Toxicology
• Decision Date: Sep 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

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.

Device Story

RapidFRET Oral Fluid Assay is a competitive homogeneous immunoassay for qualitative methamphetamine detection in oral fluid. Input: neat oral fluid collected via RapidEASE Oral Fluid Collector. Operation: drug in sample competes with donor-fluorophore-labeled drug for antibody-acceptor-fluorophore binding sites; binding brings fluorophores into proximity, enabling fluorescence resonance energy transfer (FRET). Output: FRET signal measured by RapidFRET Integrated Workstation; signal inversely proportional to drug concentration. Used in central laboratories by trained personnel. Results are preliminary; require confirmation via GC/MS or LC/MS/MS. Clinical decision-making relies on professional judgment; benefits include rapid screening for drug presence.

Clinical Evidence

Bench testing only. Precision evaluated over 20 days using spiked samples (0-200% of cutoff). Accuracy assessed by comparing 92 clinical samples against LC/MS/MS confirmation. Cross-reactivity and analytical specificity tested against structurally related compounds, common substances, and pH variations. Results demonstrate analytical sensitivity between 75% and 125% of cutoff and performance equivalent to the predicate.

Technological Characteristics

Competitive homogeneous time-resolved fluorescence immunoassay. Components: drug-specific antibody reagent and drug conjugate reagent. Platform: RapidFRET Integrated Workstation. Sample collection: RapidEASE Oral Fluid Collector (neat oral fluid, no diluent). Cutoff: 50 ng/mL. Controls/Calibrators: drug-specific materials for system monitoring.

Indications for Use

Indicated for qualitative screening of methamphetamine at 50 ng/mL in neat oral fluid samples. Intended for prescription use in central laboratories. Provides preliminary results requiring confirmation by GC/MS or LC/MS/MS.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Lin-Zhi International, Inc., LZI Oral Fluid Methamphetamine Enzyme Immunoassay (k131652)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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### 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: [phone]
- Fax: [phone]

### 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 | Regulation<br>Section | 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

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

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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<br>(RapidFRET MET) | Predicate Device<br>(Lin-Zhi MET, K131652) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Qualitative determination of<br>methamphetamine in human oral fluid in<br>clinical setting. | Qualitative determination of<br>methamphetamine in human oral fluid in<br>clinical setting. |
| Methodology | Competitive homogeneous<br>immunoassay. | Competitive homogeneous<br>immunoassay. |
| Kit<br>Components | 1 Drug specific antibody reagent in liquid,<br>ready to use format.<br>1 Drug conjugate reagent in liquid, ready<br>to use format. | A drug specific antibody reagent (R1) and<br>a drug conjugate reagent (R2). |
| Performance<br>Characteristics | Precision, accuracy, cross<br>reacting/interfering studies demonstrate<br>equivalence to the predicate device. | Precision, accuracy, cross<br>reacting/interfering studies are similar to<br>the RapidFRET Oral Fluid Assay for<br>Methamphetamine. |
| 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<br>(RapidFRET MET) | Predicate Device<br>(Lin-Zhi MET, K131652) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Effectiveness | described in PI, equivalent to predicate. | described in PI. |
| Neat Oral Fluid<br>Cutoff Level | 50 ng/mL neat oral fluid. | 50 ng/mL neat oral fluid. |
| Platform | RapidFRET Integrated Workstation<br>available exclusively from Biophor<br>Diagnostics, Inc. | MGC240 analyzer |
| Sample<br>Collection | Neat oral fluid is collected with the<br>RapidEASE Oral Fluid Collector via direct<br>expectoration. No diluent is used and<br>sample is stored in glass sample tube<br>with inert screw cap. | Oral fluid is collected with the LZI Oral<br>Fluid collector. |
| Principle and<br>Procedure | Drugs in the oral fluid sample compete<br>with the drug conjugate donor<br>fluorophore for a fixed number of binding<br>sites on the individual drug antibody<br>acceptor reagents. When acceptor and<br>donor fluorophores are brought into<br>close proximity, through the binding<br>event, fluorescent energy transfer is<br>measured.<br><br>The amount of drug in the specimen<br>sample is inversely proportional to the<br>assay signal as measured by time<br>resolved fluorescence. | The assay is based on competition of<br>drugs in a sample and drug labeled<br>G6PDH. Drug in the sample binds to the<br>drug specific antibody leaving G6PDH<br>active to produce assay signal. If no drug<br>is present in sample, it binds to the<br>labeled G6PDH enzyme inhibiting activity.<br><br>The amount of drug in the specimen is<br>proportional to the assay signal as<br>measured by absorbance. |
| Controls and<br>Calibrator<br>Levels | Calibrators are available at effective<br>concentrations of 0 ng/mL and 50 ng/mL.<br>Controls are available at effective<br>concentrations of 25 ng/mL and 75<br>ng/mL. | Calibrators are available at 0 ng/mL, 20<br>ng/mL, 50 ng/mL, 100 ng/mL and 140<br>ng/mL. Controls are available at 37.5<br>ng/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% of<br>Cutoff | 100% to 150% of<br>Cutoff | >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 Equivalent<br>Concentration (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 Equivalent<br>Concentration (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.