SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
Device Facts
| Record ID | K203647 |
|---|---|
| Device Name | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay |
| Applicant | Immunalysis Corporation |
| Product Code | LAF · Clinical Toxicology |
| Decision Date | Dec 22, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3610 |
| Device Class | Class 2 |
Intended Use
For In Vitro Diagnostic Use. The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 50 ng/mL in neat oral fluid collected by Quantisal or Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of methamphetamine in human oral fluid with clinical analyzers. This assay is calibrated against d-methamphetamine. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
Device Story
The SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an in-vitro diagnostic test for detecting methamphetamine in human oral fluid. Samples are collected using the Quantisal or Quantisal II Oral Fluid Collection Device, which stores the specimen in a preservative buffer. The assay utilizes a homogeneous enzyme immunoassay principle on automated clinical chemistry analyzers (e.g., Beckman Coulter AU480). It provides qualitative or semi-quantitative results calibrated against d-methamphetamine. The device is intended for laboratory use; results are preliminary and require confirmation by GC-MS or LC-MS/MS. The semi-quantitative mode assists laboratories in determining specimen dilution for confirmation or establishing quality control. The device aids in workplace drug testing, pain management monitoring, and DUID assessments by identifying methamphetamine presence, allowing clinicians to make informed decisions regarding patient compliance or substance use.
Clinical Evidence
Bench testing only. Precision/reproducibility study (15-day, N=60 per concentration) and linearity study (20-220 ng/mL range) performed. Method comparison study (N=80 clinical samples) against LC-MS/MS showed 100% agreement in both qualitative and semi-quantitative modes. Interference testing confirmed no cross-reactivity with structurally related/unrelated compounds, endogenous substances, or common oral products.
Technological Characteristics
Homogeneous enzyme immunoassay; utilizes β-galactosidase complementation technology. Reagents: Enzyme Acceptor (EA) with recombinant antibodies and Enzyme Donor (ED) with drug conjugate. Dimensions/form factor: liquid reagents for automated clinical chemistry analyzers. Storage: 2-8°C. Standards: CLSI EP07-A2 (interference), ISO 14971 (risk management).
Indications for Use
Indicated for the qualitative and semi-quantitative analysis of methamphetamine in human oral fluid collected via Quantisal or Quantisal II devices. Intended for use in clinical laboratories to provide preliminary analytical results for methamphetamine detection.
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
- LZI Oral Fluid Methamphetamine Enzyme Immunoassay, LZI Oral Fluid Methamphetamine Calibrators, LZI Oral Fluid Methamphetamine Controls (K131652)
Related Devices
- K972989 — STC METHAMPHETAMINE MICRO-PLATE EIA · OraSure Technologies, Inc. · Jan 28, 1998
- K080381 — QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA · Quest Diagnostics, Inc. · Jun 25, 2008
- K051577 — IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS · Immunalysis Corporation · Oct 4, 2005
Submission Summary (Full Text)
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December 22, 2021
Immunalysis Corporation Elina Arroyo Manager Regulatory Affairs 829 Towne Center Drive Pomona, California 91767
Re: K203647
Trade/Device Name: SEFRIATM Methamphetamine Oral Fluid Enzyme Immunoassay Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: Class II Product Code: LAF Dated: October 7, 2021 Received: October 8, 2021
Dear Elina Arroyo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 Part 801 and Part 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiologial Health
Enclosure
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## Indications for Use
510(k) Number (if known)
k203647
Device Name
SEFRIA™ Methamphetamine Oral Fluid Enzyme Immunoassay
Indications for Use (Describe) For In Vitro Diagnostic Use.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 50 ng/mL in neat oral fluid collected by Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of methamphetamine in human oral fluid with clinical analyzers. This assay is calibrated against d-methamphetamine.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> |
|----------------------------------------------|---------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> |
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## 510(K) SUMMARY
510(k) Number: k203647
#### A. GENERAL INFORMATION
| Applicant Name: | Immunalysis Corporation<br>829 Towne Center Drive<br>Pomona, CA 91767<br>Establishment # 2020952 |
|------------------|--------------------------------------------------------------------------------------------------|
| Company Contact: | Elina Arroyo, Manager Regulatory Affairs<br>Immunalysis Corporation |
829 Towne Center Drive, Pomona, CA 91767 USA (224) 361-7080 elina.arroyo@aabbott.com
October 7, 2021 Date Prepared:
# B. DEVICE IDENTIFICATION
Trade or Proprietary Names: SEFRIA™ Methamphetamine Oral Fluid Enzyme Immunoassay
Common Name: Methamphetamine Oral Fluid Enzyme Immunoassay
#### C. REGULATORY INFORMATION
| | Device Classification Name: Gas Chromatography, Methamphetamine |
|----------------------------|-------------------------------------------------------------------|
| Product Codes: | LAF |
| Regulatory Class: | Class II |
| Classification Regulation: | 862.3610 |
| Panel: | Toxicology (91) |
| Predicate Device: | LZI Oral Fluid Methamphetamine Enzyme Immunoassay, LZI Oral Fluid |
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Methamphetamine Calibrators, LZI Oral Fluid Methamphetamine
Controls [K131652]
# D. DEVICE DESCRIPTION
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an in-vitro test to detect the presence of methamphetamine in human oral fluid samples collected by Quantisal or Quantisal II Oral Fluid Collection Device.
Methamphetamine is a stimulant drug usually used as a white, bitter-tasting powder or a pill. It is highly addictive and is rarely prescribed. When smoked, the vapor moves from the lungs to the bloodstream causing euphoria, increased energy and alertness, higher confidence, and motivation. Side effects include paranoia, tremors, loss of appetite, mood swings, and neuropsychological effects including deficits in episodic memory, executive functions, information processing speed, motor skills, language, and visuoconstructional abilities. [1] The disposition of methamphetamine in oral fluid has been well documented showing the main drug found after intake is the parent compound. Following single dosing of 10 mg and 20 mg, concentrations over 50 ng/mL of methamphetamine were detected in oral fluid.121 Oral fluid has been shown to be a useful matrix for the analysis of methamphetamine in several areas including workplace drug testing, pain management compliance monitoring, and driving under the influence of drugs. [3],[4],[5]
# E. INTENDED USE
For In Vitro Diagnostic Use.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 50 ng/mL in neat oral fluid collected by Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of methamphetamine in human oral fluid with clinical analyzers. This assay is calibrated against dmethamphetamine.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to
<sup>4</sup> Cobb Scott J, Woods SP, Matt GE, Meyer RA, Heaton RK, Atkinson JH, Grant I. Neurocognitive effects of methamphetamine: A critical review and meta-analysis. Neuropsych Review. 2007;17(3):275-297.
<sup>2</sup> Huestis MA、Cone EJ. Methamphetamine disposition in oral fluid, plasma and urine. Ann NY Acad Sci. 2007:1098:104-121.
<sup>3</sup> Moore C. Oral fluid and hair in workplace drug testing programs: new technology for immunoassays. Drug Test Anal. 2011;3(3):166-168.
<sup>4</sup> Moore C. Drug testing and adherence monitoring in pain management: Oral fluid testing. J Opioid Manage. 2015;11(1):69-75.
<sup>5</sup> Veitenheimer AM, Wagner JR. Evaluation of oral fluid as a specimen for DUID. J Anal Toxicol. 2017;41(6):517-522.
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obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
# F. COMPARISON WITH PREDICATE
| Attribute | Candidate Device<br>SEFRIA Methamphetamine Oral<br>Fluid Enzyme Immunoassay | Predicate Device<br>LZI Oral Fluid<br>Methamphetamine Enzyme<br>Immunoassay [K131652] |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Test Principle | Identical | Homogeneous enzyme<br>immunoassay |
| Calibrated<br>Against | Identical | d-methamphetamine |
| Assay Materials | Identical | antibody reagent, drug conjugate<br>reagent |
| Cutoff Level | Identical | 50 ng/mL |
| User<br>Environment | Identical | For use in laboratories |
| Sample Matrix | Identical | Human oral fluid |
| Reagent Storage | Identical | 2-8°C until expiration date |
| Instrumentation | Identical | Automated clinical chemistry<br>analyzer |
| Mass<br>Spectrometry<br>Confirmation | Identical | Required for preliminary positive<br>analytical results |
| Differences | | |
| Intended Use | Qualitative and semi-quantitative<br>analysis of methamphetamine in<br>human oral fluid collected by<br>Quantisal or Quantisal II Oral Fluid<br>Collection Device | Qualitative and semi-quantitative<br>determination of d-<br>methamphetamine in neat human<br>oral fluid collected into the LZI<br>Oral Fluid Collector |
| Sample<br>Collection<br>Device | Oral fluid is collected with the<br>Quantisal or Quantisal II Oral Fluid<br>Collection Device. Sample is stored<br>in a plastic tube containing<br>preservative buffer with snap cap. | Oral fluid is collected with the LZI<br>Oral Fluid Collector. Sample is<br>stored in a plastic tube. |
# G. PERFORMANCE CHARACTERISTICS
The following laboratory performance studies were performed to determine substantial equivalence of the SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay to the predicate device. Assay performance was established using the Beckman Coulter AU480 chemistry analyzer.
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# 1. Precision
Precision study was performed over 15 days, 2 runs per day with 2 collection devices per run (N=60), one replicate per collection device on 1 lot of reagent and 1 lot of Quantisal and 1 lot of Quantisal II oral fluid collection devices. Drug free negative oral fluid was spiked to concentrations of assay cutoff and ±25%, ±50%, ±75%, ±100% of the cutoff and was collected using the collection devices. The spiked concentrations were confirmed by mass spectrometry (LC-MS/MS) before collection. The study established the repeatability of the testing system. including assay and oral fluid collection device. Test results in qualitative and semi-quantitative modes are presented in Tables 1 to 6.
An additional 20-day study was performed on 3 lots of assay reagent to demonstrate the repeatability across multiple reagent lots.
| Concentration<br>(ng/mL) | % of Cutoff | # of Determinations | Result |
|--------------------------|-------------|---------------------|---------------|
| 0 | -100% | 60 | 60 Negative |
| 12.5 | -75% | 60 | 60 Negative |
| 25 | -50% | 60 | 60 Negative |
| 37.5 | -25% | 60 | 60 Negative |
| 50 | Cutoff | 60 | 26 Neg/34 Pos |
| 62.5 | +25% | 60 | 60 Positive |
| 75 | +50% | 60 | 60 Positive |
| 87.5 | +75% | 60 | 60 Positive |
| 100 | +100% | 60 | 60 Positive |
Table 1. Precision - Qualitative - Quantisal
| | Table 2. Precision - Semi-Quantitative - Quantisal | |
|--|----------------------------------------------------|--|
|--|----------------------------------------------------|--|
| Concentration<br>(ng/mL) | % of<br>Cutoff | # of<br>Determinations | Mean Conc.<br>(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|---------------|
| 0 | -100% | 60 | 1.1 | 60 Negative |
| 12.5 | -75% | 60 | 14.2 | 60 Negative |
| 25 | -50% | 60 | 25.3 | 60 Negative |
| 37.5 | -25% | 60 | 39.3 | 60 Negative |
| 50 | Cutoff | 60 | 50.2 | 37 Neg/23 Pos |
| 62.5 | +25% | 60 | 68.9 | 60 Positive |
| 75 | +50% | 60 | 78.9 | 60 Positive |
| 87.5 | +75% | 60 | 93.8 | 60 Positive |
| 100 | +100% | 60 | 112.2 | 60 Positive |
Table 3. Precision - Qualitative - Quantisal II Pad A
| Concentration<br>(ng/mL) | % of Cutoff | # of Determinations | Result |
|--------------------------|-------------|---------------------|-------------|
| 0 | -100% | 60 | 60 Negative |
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| Concentration<br>(ng/mL) | % of Cutoff | # of Determinations | Result |
|--------------------------|-------------|---------------------|---------------|
| 12.5 | -75% | 60 | 60 Negative |
| 25 | -50% | 60 | 60 Negative |
| 37.5 | -25% | 60 | 60 Negative |
| 50 | Cutoff | 60 | 34 Neg/26 Pos |
| 62.5 | +25% | 60 | 60 Positive |
| 75 | +50% | 60 | 60 Positive |
| 87.5 | +75% | 60 | 60 Positive |
| 100 | +100% | 60 | 60 Positive |
#### Table 4. Precision - Semi-Quantitative – Quantisal II Pad A
| Concentration<br>(ng/mL) | % of<br>Cutoff | # of<br>Determinations | Mean Conc.<br>(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|---------------|
| 0 | -100% | 60 | 2.4 | 60 Negative |
| 12.5 | -75% | 60 | 14.7 | 60 Negative |
| 25 | -50% | 60 | 25.1 | 60 Negative |
| 37.5 | -25% | 60 | 38.4 | 60 Negative |
| 50 | Cutoff | 60 | 48.6 | 44 Neg/16 Pos |
| 62.5 | +25% | 60 | 63.8 | 60 Positive |
| 75 | +50% | 60 | 74.9 | 60 Positive |
| 87.5 | +75% | 60 | 86.8 | 60 Positive |
| 100 | +100% | 60 | 109.3 | 60 Positive |
# Table 5. Precision - Qualitative - Quantisal II Pad B
| Concentration<br>(ng/mL) | % of Cutoff | # of Determinations | Result |
|--------------------------|-------------|---------------------|---------------|
| 0 | -100% | 60 | 60 Negative |
| 12.5 | -75% | 60 | 60 Negative |
| 25 | -50% | 60 | 60 Negative |
| 37.5 | -25% | 60 | 60 Negative |
| 50 | Cutoff | 60 | 31 Neg/29 Pos |
| 62.5 | +25% | 60 | 60 Positive |
| 75 | +50% | 60 | 60 Positive |
| 87.5 | +75% | 60 | 60 Positive |
| 100 | +100% | 60 | 60 Positive |
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| Concentration<br>(ng/mL) | % of<br>Cutoff | # of<br>Determinations | Mean Conc.<br>(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|---------------|
| 0 | -100% | 60 | 3.8 | 60 Negative |
| 12.5 | -75% | 60 | 14.7 | 60 Negative |
| 25 | -50% | 60 | 24.9 | 60 Negative |
| 37.5 | -25% | 60 | 40.4 | 60 Negative |
| 50 | Cutoff | 60 | 49.0 | 42 Neg/18 Pos |
| 62.5 | +25% | 60 | 65.8 | 60 Positive |
| 75 | +50% | 60 | 78.3 | 60 Positive |
| 87.5 | +75% | 60 | 89.0 | 60 Positive |
| 100 | +100% | 60 | 111.9 | 60 Positive |
Table 6. Precision - Semi-Quantitative - Quantisal II Pad B
# 2. Specificity and Cross-Reactivity
Structurally and functionally similar compounds were spiked into drug free pooled oral fluid at levels that will yield a result that is equivalent to the cutoff, if cross reacting. The study verified the cross reactivity of the methamphetamine assay to related drugs and drug metabolites, in both the qualitative and semi-quantitative modes. Cross-reactivity test results in qualitative mode are presented in Table 7. Cross-reactivity test results in semi-quantitative mode are presented in Table 8.
| | Table 7. Cross-Reactivitv – Qualitative | |
|--|-----------------------------------------|--|
|--|-----------------------------------------|--|
| Compound | Compound<br>Conc. (ng/mL) | Methamphetamine<br>Equivalent Conc.<br>(ng/mL) | Result | Cross-<br>Reactivity<br>(%) |
|------------------------------------------------------|---------------------------|------------------------------------------------|--------|-----------------------------|
| l-Methamphetamine | 7,500 | 50 | POS | 0.7 |
| d,l-Methamphetamine | 110 | 50 | POS | 45.5 |
| d-Amphetamine | 8,000 | 50 | POS | 0.6 |
| l-Amphetamine | 40,000 | <50 | NEG | <0.1 |
| Diphenhydramine | 40,000 | <50 | NEG | <0.1 |
| Doxylamine | 40,000 | <50 | NEG | <0.1 |
| d-Ephedrine | 40,000 | <50 | NEG | <0.1 |
| l-Ephedrine | 4,250 | 50 | POS | 1.2 |
| Fenfluramine | 5,000 | 50 | POS | 1.0 |
| Methylenedioxymethamphetamine<br>(MDMA) | 55 | 50 | POS | 90.9 |
| (±)-3,4-<br>Methylenedioxyethylamphetamine<br>(MDEA) | 110 | 50 | POS | 45.5 |
| Methylenedioxyamphetamine<br>(MDA) | 6,000 | 50 | POS | 0.8 |
| Methylone | 27,500 | 50 | POS | 0.2 |
| 4-Methoxyamphetamine (PMA) | 3,250 | 50 | POS | 1.5 |
| Para-Methoxy-N-<br>Methylamphetamine (PMMA) | 27.75 | 50 | POS | 180.2 |
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| Compound | Compound<br>Conc. (ng/mL) | Methamphetamine<br>Equivalent Conc.<br>(ng/mL) | Result | Cross-<br>Reactivity<br>(%) |
|---------------------------|---------------------------|------------------------------------------------|--------|-----------------------------|
| Phenethylamine | 40,000 | <50 | NEG | <0.1 |
| Phenylephrine | 40,000 | <50 | POS | <0.1 |
| Phentermine | 40,000 | <50 | POS | <0.1 |
| Phenylpropanolamine (PPA) | 40,000 | <50 | POS | <0.1 |
| d-Pseudoephedrine | 15,000 | 50 | POS | 0.3 |
| l-Pseudoephedrine | 40,000 | 50 | NEG | 0.1* |
| Tyramine | 40,000 | <50 | NEG | <0.1 |
*As the Semi-Quantitative result is positive, the % cross reactivity is calculated based on Semi-Quantitative result.
| Compound | Compound<br>Conc.<br>(ng/mL) | Methamphetamine<br>Equivalent Conc.<br>(ng/mL) | Mean<br>Value<br>(ng/mL) | Result | Cross-Reactivity<br>(%) |
|---------------------------------------------------|------------------------------|------------------------------------------------|--------------------------|--------|-------------------------|
| l-Methamphetamine | 7,500 | 50 | 54.4 | POS | 0.7 |
| d,l-Methamphetamine | 110 | 50 | 54.1 | POS | 45.5 |
| d-Amphetamine | 8,000 | 50 | 51.2 | POS | 0.6 |
| l-Amphetamine | 40,000 | <50 | 28.9 | NEG | <0.1 |
| Diphenhydramine | 40,000 | <50 | 2.8 | NEG | <0.1 |
| Doxylamine | 40,000 | <50 | 2.3 | NEG | <0.1 |
| d-Ephedrine | 40,000 | <50 | 22.9 | NEG | <0.1 |
| l-Ephedrine | 4,250 | 50 | 50.0 | POS | 1.2 |
| Fenfluramine | 5,000 | 50 | 54.3 | POS | 1.0 |
| Methylenedioxymethamphetamine (MDMA) | 55 | 50 | 51.3 | POS | 90.9 |
| (±)-3,4-<br>Methylenedioxyethylamphetamine (MDEA) | 110 | 50 | 50.0 | POS | 45.5 |
| Methylenedioxyamphetamine (MDA) | 6,000 | 50 | 53.7 | POS | 0.8 |
| Methylone | 27,500 | 50 | 52.2 | POS | 0.2 |
| Methoxyamphetamine<br>(PMA) | 3,250 | 50 | 53.6 | POS | 1.5 |
| Para-Methoxy-N-<br>Methylamphetamine<br>(PMMA) | 27.75 | 50 | 51.5 | POS | 180.2 |
| Phenethylamine | 40,000 | <50 | 14.1 | NEG | <0.1 |
| Phenylephrine | 40,000 | <50 | 14.8 | POS | <0.1 |
| Phentermine | 40,000 | <50 | 35.2 | POS | <0.1 |
| Phenylpropanolamine<br>(PPA) | 40,000 | <50 | 15.9 | POS | <0.1 |
| d-Pseudoephedrine | 15,000 | 50 | 52.5 | POS | 0.3 |
| l-Pseudoephedrine | 40,000 | 50 | 50.0 | POS | 0.1 |
| Tyramine | 40,000 | <50 | 15.4 | NEG | <0.1 |
#### Table 8. Cross-Reactivity - Semi-Quantitative
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## 3. Interference - Structurally Unrelated Compounds
Structurally unrelated compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free oral fluid containing methamphetamine at ±25% of the cutoff. At the levels tested, there was no interference with structurally unrelated compounds. The concentration levels of structurally unrelated compounds are presented in Table 9.
| Compound | Conc. Tested (ng/mL) |
|-------------------------------------|----------------------|
| 4-Bromo-2,5,Dimethoxyphenethylamine | 40,000 |
| Acetaminophen | 40,000 |
| 6-Acetylcodeine | 40,000 |
| 6-Acetylmorphine | 40,000 |
| Alprazolam | 40,000 |
| 7-Aminoclonazepam | 40,000 |
| 7-Aminoflunitrazepam | 40,000 |
| 7-Aminonitrazepam | 40,000 |
| Amitriptyline | 40,000 |
| Amobarbital | 40,000 |
| Benzylpiperazine | 5,000 |
| Bromazepam | 40,000 |
| Buprenorphine | 40,000 |
| Bupropion | 40,000 |
| Butabarbital | 40,000 |
| Butalbital | 40,000 |
| Cannabidiol | 40,000 |
| Cannabinol | 40,000 |
| Carbamazepine | 40,000 |
| Carisoprodol | 40,000 |
| Chlordiazepoxide | 40,000 |
| Chlorpromazine | 40,000 |
| cis-Tramadol | 40,000 |
| Clobazam | 40,000 |
| Clomipramine | 40,000 |
| Clonazepam | 40,000 |
| Cocaine | 40,000 |
| Clozapine | 40,000 |
| Codeine | 40,000 |
| Cotinine | 40,000 |
| Cyclobenzaprine | 40,000 |
| Demoxepam | 40,000 |
| Compound | Conc. Tested (ng/mL) |
| Desakylflurazepam | 40,000 |
| Desipramine | 15,000 |
| Desomorphine | 40,000 |
| Dextromethorphan | 40,000 |
| Dihydrocodeine | 40,000 |
| Diazepam | 40,000 |
| Digoxin | 40,000 |
| Dehydronorketamine | 40,000 |
| Delta-9-THC | 40,000 |
| Doxepin | 35,000 |
| Ecgonine | 40,000 |
| Ecgonine Methyl Ester | 40,000 |
| EDDP | 40,000 |
| EMDP | 40,000 |
| Ethyl-β-D-Glucuronide | 40,000 |
| Ethylmorphine | 40,000 |
| Fentanyl | 40,000 |
| Flunitrazepam | 40,000 |
| Fluoxetine | 15,000 |
| Flurazepam | 40,000 |
| Haloperidol | 40,000 |
| Heroin | 40,000 |
| Hydrocodone | 40,000 |
| Hydromorphone | 40,000 |
| 11-hydroxy-delta-9-THC | 40,000 |
| Imipramine | 40,000 |
| Ketamine | 40,000 |
| Lamotrigine | 40,000 |
| Levorphanol | 40,000 |
| Lidocaine | 40,000 |
| Lorazepam | 40,000 |
| Lorazepam Glucuronide | 40,000 |
| Lormetazepam | 40,000 |
| LSD | 40,000 |
| Maprotiline | 40,000 |
| Meperidine | 40,000 |
| Meprobamate | 40,000 |
| Methadone | 40,000 |
| Methaqualone | 40,000 |
| Compound | Conc. Tested (ng/mL) |
| Methoxetamine | 40,000 |
| Methylphenidate | 40,000 |
| Midazolam | 40,000 |
| Morphine | 40,000 |
| Morphine-3-Glucuronide | 40,000 |
| Morphine-6-Glucuronide | 40,000 |
| N-desmethyl tapentadol | 40,000 |
| N-desmethyl tramadol | 40,000 |
| N-desmethyl venlafaxine | 40,000 |
| Nalorphine | 40,000 |
| Naloxone | 40,000 |
| Naltrexone | 40,000 |
| Naproxen | 40,000 |
| Nitrazepam | 40,000 |
| 11-nor-9 carboxy THC | 40,000 |
| Norbuprenorphine | 40,000 |
| Norcodeine | 40,000 |
| Nordiazepam | 40,000 |
| Norketamine | 40,000 |
| Normorphine | 40,000 |
| Noroxycodone | 40,000 |
| Noroxymorphone | 40,000 |
| Norpropoxyphene | 40,000 |
| Norpseudoephedrine | 40,000 |
| Nortriptyline | 20,000 |
| O-desmethyl tramadol | 40,000 |
| O-desmethyl venlafaxine | 40,000 |
| Oxycodone | 40,000 |
| Oxymorphone | 40,000 |
| Oxycodone-3-β-Glucuronide | 40,000 |
| Olanzapine | 40,000 |
| Oxazepam | 40,000 |
| PCP | 40,000 |
| Pentazocine | 40,000 |
| Pentobarbital | 40,000 |
| Phenobarbital | 40,000 |
| Phenytoin | 40,000 |
| Prazepam | 40,000 |
| Propranolol | 40,000 |
| Compound | Conc. Tested (ng/mL) |
| Propoxyphene | 40,000 |
| Protriptyline | 20,000 |
| Ritalinic Acid | 40,000 |
| Salicylic Acid | 40,000 |
| Secobarbital | 40,000 |
| Sertraline | 40,000 |
| Sufentanil | 40,000 |
| Tapentadol | 40,000 |
| Temazepam | 40,000 |
| Theophylline | 40,000 |
| Thioridazine | 40,000 |
| Trazadone | 40,000 |
| Triazolam | 40,000 |
| 3-Trifluoromethylphenyl-piperazine | 20,000 |
| Trimipramine | 20,000 |
| Venlafaxine | 40,000 |
| Verapamil | 30,000 |
| Zolpidem | 40,000 |
Table 9. Non-Interfering Structurally Unrelated Compounds
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#### 4. Interference - Endogenous Compounds and Exogenous Compounds
Endogenous compounds and exogenous compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free oral fluid containing methamphetamine at ±25% of the cutoff. Additional orally used products were tested by collecting oral fluid using Quantisal and Quantisal II Oral Fluid Collection Devices from volunteers after use of the substances. At the levels tested, there was no interference observed with endogenous compounds, exogenous compounds and orally used compounds. Endogenous compounds and exogenous compounds are presented in Tables 10 and 11. Orally used compounds tested are presented in Table 12.
| Compound | Concentration Tested |
|---------------------|----------------------|
| Ascorbic Acid | 2 mg/mL |
| Bilirubin | 0.15 mg/mL |
| Cholesterol | 0.45 mg/mL |
| γ-Globulin | 0.8 mg/mL |
| Hemoglobin | 2 mg/mL |
| Human Serum Albumin | 15 mg/mL |
| IgA | 1 mg/mL |
| IgG | 1 mg/mL |
| IgM | 0.5 mg/mL |
| Salivary-α-amylase | 1000 U/mL |
#### Table 10. Non-interfering Endogenous Compounds
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| Compound | Concentration Tested |
|----------------------|----------------------|
| Acetylsalicylic Acid | 0.01 mg/mL |
| Baking Soda | 0.6% v/v |
| Denture Adhesive | 0.6% w/v |
| Ibuprofen | 0.01 mg/mL |
| Alcohol (Ethanol) | 6% v/v |
| Caffeine | 0.01 mg/mL |
| Coffee | 6% v/v |
| Cranberry Juice | 6% v/v |
| Milk | 1% v/v |
| Mouthwash | 6% v/v |
| Naproxen | 0.01 mg/mL |
| Orange Juice | 2% v/v |
| Soft Drink (Pepsi) | 6% v/v |
| Sodium Chloride | 18 mg/mL |
| Sugar | 10 mg/mL |
| Tea | 6% v/v |
| Toothpaste | 6% w/v |
Table 11. Non-interfering Exogenous Compounds
Table 12. Non-interfering Orally Used Exogenous Products
| Compound | Concentration Tested |
|----------------------------|---------------------------|
| Teeth Whitener | 2 strips |
| Cigarette | 1 cigarette |
| Hard Candy | 1 piece |
| Chewing Gum | 1 piece |
| Hydrogen Peroxide (3% OTC) | Neat (2 min. mouth rinse) |
| Sugar | 2 Teaspoons |
| Cough Syrup | 2 Teaspoons |
| Milk | 100 mL |
| Orange Juice | 100 mL |
| Ibuprofen | 200 mg |
| Acetaminophen | 1000 mg |
# 5. Interference - pH
To evaluate potential interference from the effect of oral fluid pH, device performance in the qualitative and semi-quantitative modes was tested using a range of oral fluid pH values (3.0, 4.0, 5.0, 8.0, 9.0, 10.0 and 11.0). All test samples were prepared in drug free oral fluid containing methamphetamine at ±25% of the cutoff. At the pH levels tested, there was no interference observed for each test mode.
#### 6. Linearity/Recovery
Assay linearity was evaluated in the semi-quantitative mode by spiking a drug free oral fluid pool with a high concentration of methamphetamine. Additional pools were made by serially diluting the high concentration specimen with drug free oral fluid to achieve concentrations ranging from 20 ng/mL to
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220 ng/mL. The 0 ng/mL specimen was made from drug free oral fluid. Each pool was collected by Quantisal and Quantisal II oral fluid collection devices and tested in triplicate to calculate the mean concentration values that were used to calculate drug recovery. Linearity test results in semi-quantitative mode are presented in Tables 13 to 15. The study confirmed the linear range to be 20-200 ng/mL with a drug recovery percentage of 93.9% to 109.2% across the collection devices.
| Expected Concentration | Mean Concentration | Recovery (%) |
|------------------------|--------------------|--------------|
| (ng/mL) | (ng/mL) | |
| 0 | 1.0 | N/A |
| 20 | 20.7 | 103.3 |
| 40 | 43.1 | 107.8 |
| 50 | 51.9 | 103.8 |
| 60 | 64.8 | 107.9 |
| 80 | 81.2 | 101.5 |
| 100 | 96.8 | 96.8 |
| 120 | 127.7 | 106.4 |
| 140 | 141.4 | 101.0 |
| 160 | 150.3 | 93.9 |
| 180 | 184.6 | 102.6 |
| 200 | 194.8 | 97.4 |
| 220 | 225.3 | 102.4 |
# Table 13. Linearity/Recovery - Quantisal
| Table 14, Linearity/Recoverv – Quantisal II "A" | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
| Expected Concentration<br>(ng/mL) | Mean Concentration<br>(ng/mL) | Recovery (%) |
|-----------------------------------|-------------------------------|--------------|
| 0 | -1.4 | N/A |
| 20 | 20.5 | 102.5 |
| 40 | 41.6 | 103.9 |
| 50 | 48.4 | 96.8 |
| 60 | 59.3 | 98.9 |
| 80 | 78.2 | 97.8 |
| 100 | 97.3 | 97.3 |
| 120 | 123.2 | 102.6 |
| 140 | 145.6 | 104.0 |
| 160 | 159.0 | 99.4 |
| 180 | 180.0 | 100.0 |
| 200 | 201.0 | 100.5 |
| 220 | 219.9 | 100.0 |
#### Table 15. Linearity/Recovery - Quantisal II "B"
| Expected Concentration<br>(ng/mL) | Mean Concentration<br>(ng/mL) | Recovery (%) |
|-----------------------------------|-------------------------------|--------------|
| 0 | 0.5 | N/A |
| 20 | 21.8 | 109.2 |
| 40 | 42.9 | 107.3 |
| 50 | 49.1 | 98.3 |
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| Expected Concentration<br>(ng/mL) | Mean Concentration<br>(ng/mL) | Recovery (%) |
|-----------------------------------|-------------------------------|--------------|
| 60 | 60.9 | 101.5 |
| 80 | 78.2 | 97.8 |
| 100 | 94.8 | 94.8 |
| 120 | 119.3 | 99.4 |
| 140 | 140.7 | 100.5 |
| 160 | 163.6 | 102.2 |
| 180 | 176.3 | 98.0 |
| 200 | 192.4 | 96.2 |
| 220 | 214.5 | 97.5 |
# 7. Methamphetamine Stability in Oral Fluid
Drug free negative oral fluid spiked with methamphetamine at +50% of the 50 ng/mL cutoff were collected and stored in Ouantisal II Oral Fluid Collection Devices at 2°C - 8°C. tested by LC-MS/MS at each time point and compared to the baseline concentration result. The test results indicate that oral fluid samples containing methamphetamine are stable for up to 12 months stored in Quantisal or Quantisal II Oral Fluid Collection Device at 2°C - 8°C.
Data to support 10-day storage in Quantisal II Oral Fluid Collection Device at ambient temperature 8°C - 25°C were reported in K183048 and K200801.
#### 8. Calibration Duration
Drug free negative oral fluid spiked with methamphetamine at ±25% of the cutoff were tested in qualitative mode at time points up to 14 days and in semi-quantitative at time points up to 10 days. At the initial time point, a two-point calibration curve was established in qualitative mode and multi-points calibration curve was established in semi-quantitative mode. These calibrations were used through the duration of the study. The test results met acceptance criteria up to 10 days. The recommended frequency of calibration is 7 days.
# 9. Method Comparison
80 deidentified, unaltered clinical oral fluid samples collected by Quantisal II Oral Fluid Collection Devices were obtained from clinical research facilities, analyzed for methamphetamine at assay cutoff with the SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay in both qualitative and semi-quantitative modes and compared to Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) results. The instruments used were the Beckman Coulter AU480 chemistry analyzer and an Agilent 6430 Liquid Chromatography-Tandem Mass Spectrometry. The data demonstrate that the design goal of greater than 95% agreement was achieved. Method comparison test results in qualitative and semi-quantitative modes are presented from Tables 16 to 18.
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| | Immunoassay<br>Result | LC-MS/MS Methamphetamine Concentration | | | | |
|-----------------|-----------------------|---------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|------------------------------------------------|---------------|
| | | < 25 ng/mL<br>(less than<br>-50%<br>cutoff) | 25 – 49 ng/mL<br>(between -50%<br>cutoff and<br>cutoff) | 50 – 75 ng/mL<br>(between<br>cutoff and<br>+50% cutoff) | > 75 ng/mL<br>(greater<br>than +50%<br>cutoff) | Agreement (%) |
| Qual. | Positive | 0 | 0 | 4 | 36 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi-<br>Quant. | Positive | 0 | 0 | 4 | 36 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
#### Table 16. Method Comparison – Quantisal
# Table 17. Method Comparison – Quantisal II "A"
| | Immunoassay<br>Result | LC-MS/MS Methamphetamine Concentration | | | | |
|-----------------|-----------------------|---------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|------------------------------------------------|---------------|
| | | < 25 ng/mL<br>(less than<br>-50%<br>cutoff) | 25 – 49 ng/mL<br>(between -50%<br>cutoff and<br>cutoff) | 50 – 75 ng/mL<br>(between<br>cutoff and<br>+50% cutoff) | > 75 ng/mL<br>(greater<br>than +50%<br>cutoff) | Agreement (%) |
| Qual. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| Qual. | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi-<br>Quant. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| Semi-<br>Quant. | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
## Table 18. Method Comparison - Quantisal II "B"
| Immunoassay<br>Result | LC-MS/MS Methamphetamine Concentration | | | | Agreement (%) | |
|-----------------------|---------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|------------------------------------------------|---------------|--------------|
| | < 25 ng/mL<br>(less than<br>-50%<br>cutoff) | 25 – 49 ng/mL<br>(between -50%<br>cutoff and<br>cutoff) | 50 – 75 ng/mL<br>(between<br>cutoff and<br>+50% cutoff) | > 75 ng/mL<br>(greater<br>than +50%<br>cutoff) | | |
| Qual. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi-<br>Quant. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
#### H. CONCLUSION
The information provided in this pre-market notification demonstrates that the SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its intended use.
