(380 days)
No
The summary describes a standard enzyme immunoassay for detecting oxycodone in oral fluid. There is no mention of AI, ML, or any computational methods beyond basic data analysis for performance studies.
No.
The device is described as being "For In Vitro Diagnostic Use" and is intended for the analysis of oxycodone in human oral fluid, indicating it is a diagnostic tool, not a therapeutic one.
Yes
The device is explicitly stated to be "For In Vitro Diagnostic Use" and its function is to analyze oxycodone in human oral fluid, which aligns with the definition of a diagnostic device.
No
The device is an in vitro diagnostic immunoassay kit, which includes reagents and is used with a specific oral fluid collection device and clinical analyzers. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
- Device Description: The "Device Description" section describes the device as an "in vitro test to detect the presence of oxycodone in human oral fluid samples."
- Nature of the Test: The assay analyzes a biological sample (oral fluid) outside of the body to detect a specific substance (oxycodone), which is the core definition of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use. The Immunalysis SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 30 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 oxycodone in human oral fluid with clinical analyzers. This assay is calibrated against oxycodone.
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 Oxycodone 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.
Product codes
DJG
Device Description
The SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is an in vitro test to detect the presence of oxycodone in human oral fluid samples collected by Quantisal II Oral Fluid Collection Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral fluid from human
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For use in laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Precision:
- Study Design: 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.
- Objective: Established the repeatability of the testing system, including assay and oral fluid collection device.
- Results: 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.
- Specificity and Cross-Reactivity:
- Study Design: 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.
- Objective: Verified the cross reactivity of the oxycodone assay to related drugs and drug metabolites, in both the qualitative and semi-quantitative modes.
- Results: 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.
- Interference - Structurally Unrelated Compounds:
- Study Design: Structurally unrelated compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free oral fluid containing oxycodone at ±25% of the cutoff.
- Results: At the levels tested, there was no interference with structurally unrelated compounds. The concentration levels of structurally unrelated compounds are presented in Table 9.
- Interference - Endogenous Compounds and Exogenous Compounds:
- Study Design: Endogenous compounds and exogenous compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free oral fluid containing oxycodone at ±25% of the cutoff. Additional orally used products were tested by collecting oral fluid using Quantisal II Oral Fluid Collection Devices from volunteers after use of the substances.
- Results: 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 are presented in Table 12.
- Interference - pH:
- Study Design: 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, 6.0, 7.0, 8.0, 9.0. 10.0 and 11.0). All test samples were prepared in drug free oral fluid containing oxycodone at ±25% of the cutoff.
- Results: At the pH levels tested, there was no interference observed for each test mode.
- Linearity/Recovery:
- Study Design: Assay linearity was evaluated in the semi-quantitative mode by spiking a drug free oral fluid pool with a high concentration of oxycodone. Additional pools were made by serially diluting the high concentration specimen with drug free oral fluid to achieve concentrations ranging from 10 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.
- Results: Linearity test results in semi-quantitative mode are presented in Tables 13 to 15. The study confirmed the linear range to be 10-100 ng/mL with a drug recovery percentage of 90.6% to 111.6% across the collection devices.
- Oxycodone Stability in Oral Fluid:
- Study Design: Drug free negative oral fluid spiked with oxycodone at +50% of the 30 ng/mL cutoff were collected and stored in Quantisal and Quantisal 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.
- Results: Results indicate that oral fluid samples containing oxycodone are stable for up to 12 months stored in 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.
- Calibration Duration:
- Study Design: Drug free negative oral fluid spiked with oxycodone 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 25 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.
- Results: The test results met acceptance criteria at each time point up to 24 days. The recommended frequency of calibration is 14 days.
- Method Comparison:
- Study Design: Eighty (80) de-identified, unaltered clinical oral fluid samples collected by Quantisal II Oral Fluid Collection Devices were obtained from clinical research facilities, analyzed for oxycodone at assay cutoff with the SEFRIA Oxycodone 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.
- Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not directly reported as sensitivity, specificity, PPV, or NPV, but agreement rates are provided in the Method Comparison study: 100% agreement.
Predicate Device(s)
Thermo Scientific CEDIA Opiate OFT Assay [K101754]
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).
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December 22, 2021
Immunalysis Corporation Elina Arroyo Manager Regulatory Affairs 829 Towne Center Drive Pomona, California 91767
Re: K203564
Trade/Device Name: SEFRIATM Oxycodone Oral Fluid Enzyme Immunoassay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG 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
2
Indications for Use
510(k) Number (if known)
K203564
Device Name SEFRIATM Oxycodone Oral Fluid Enzyme Immunoassay
Indications for Use (Describe) For In Vitro Diagnostic Use.
The Immunalysis SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 30 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 oxycodone in human oral fluid with clinical analyzers. This assay is calibrated against oxycodone.
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 Oxycodone 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
510(k) Number: K203564
A. GENERAL INFORMATION
| Applicant Name: | Immunalysis Corporation |
|---|---|
| 829 Towne Center Drive | |
| Pomona, CA 91767 | |
| Establishment # 2020952 |
| Company Contact: | Elina Arroyo, Manager Regulatory Affairs
Immunalysis Corporation
829 Towne Center Drive, Pomona, CA 91767 USA
(224) 361-7080
elina.arroyo@abbott.com |
| ------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Date Prepared: October 7, 2021
B. DEVICE IDENTIFICATION
Trade or Proprietary Names: SEFRIATM Oxycodone Oral Fluid Enzyme Immunoassay
Common Name: Oxycodone Oral Fluid Enzyme Immunoassay
C. REGULATORY INFORMATION
| Device Classification Name: | Enzyme Immunoassay, Opiates |
|---|---|
| Product Codes: | DJG |
| Regulatory Class: | Class II |
| Classification Regulation: | 862.3650 |
| Panel: | Toxicology (91) |
| Predicate Device: | Thermo Scientific CEDIA Opiate OFT Assay [K101754] |
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D. DEVICE DESCRIPTION
The SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is an in vitro test to detect the presence of oxycodone in human oral fluid samples collected by Quantisal II Oral Fluid Collection Device.
Oxycodone was developed in Germany in 1916, intended to be a better medication than other opioids such as codeine and morphine but unfortunately has significant potential for abuse and addiction. It is an opioid analgesic, most often prescribed to control moderate to severe pain; one in 16 surgical patients becomes a long-term user. Overprescribing opioids after surgery is common, and the lack of multidisciplinary procedure-specific guidelines contributes to the wide variation in opioid prescribing practice.[1] Oxycodone is present in formulations combined with other pain-relieving drugs like acetaminophen (Percocet®) or as extended release tablets (OxyContin®). The disposition of oxycodone in oral fluid has been well documented showing the main drug found after intake is the parent compound. After a single dose of 20 mg oxycodone, concentrations as high as 200 ng/mL may be detected in oral fluid.[1] Oral fluid has been shown to be a useful matrix for the analysis of oxycodone in patients undergoing addiction treatment.13,14]
E. INTENDED USE
For In Vitro Diagnostic Use.
The Immunalysis SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 30 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 oxycodone in human oral fluid with clinical analyzers. This assay is calibrated against oxycodone.
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 Oxycodone 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.
1 Overton HN, Hanna MN, Bruhn WE, Hutfless S, Bicket MC, Makary MA. Opioid-prescribing guidelines for common surgical procedures: An Expert Panel Consensus. J Am Coll Surg. 2018 Oct;227(4):411-418.
2 Cone EJ, DePriest AZ, Heltsley R, Black DL, Mitchell JM, LoDico C, Flegel R. Prescription Opioids. III. Disposition of oxycodone in oral fluid and blood following controlled single-dose administration. J Anal Toxicol. 2015;39(3):192-202.
3 Kunkel F, Fey E, Borg D, Stripp R, Getto C. Assessment of the use of oral fluid as a matrix for drug monitoring in patients undergoing treatment for opioid addiction. J Opioid Manag. 2015:11(5):435-42.
4 Conermann T, Gosalia AR, Kabazie AJ, Moore C, Miller K, Fetsch M, Irvan D. Utility of oral fluid in compliance monitoring of opioid medications. Pain Physician. 2014;17(1):63-70.
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F. COMPARISON WITH PREDICATE
The selected predicate device is Thermo Scientific CEDIA Opiate OFT Assay K101754.
| Attribute | Candidate Device
SEFRIA Oxycodone Oral Fluid
Enzyme Immunoassay | Predicate Device
Thermo Scientific CEDIA Opiate
OFT Assay [K101754] |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Test Principle | Identical | Homogeneous enzyme
immunoassay |
| Assay Materials | Identical | antibody reagent, drug conjugate
reagent |
| Cutoff Level | Identical | 30 ng/mL in Neat Oral Fluid |
| User
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
analyzer |
| Mass
Spectrometry
Confirmation | Identical | Required for preliminary positive
analytical results |
| Differences | | |
| Intended Use | Qualitative and semi-quantitative
analysis of oxycodone in human
oral fluid collected by Quantisal or
Quantisal II Oral Fluid Collection
Device | Qualitative determination of opiates
in human oral fluid collected by
Oral-Eze™ Saliva Collection
System |
| Calibrated
Against | Oxycodone | Morphine |
| Sample
Collection
Device | Oral fluid is collected with the
Quantisal and Quantisal II Oral
Fluid Collection Device. Sample is
stored in a plastic tube containing
preservative buffer with snap cap. | Oral fluid is collected with the
Oral-Eze™ Saliva Collection
System. Sample is stored in a
plastic tube containing preservative
buffer with snap cap. |
G. PERFORMANCE CHARACTERISTICS
The following laboratory performance studies were performed to determine substantial equivalence of the SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay to the predicate device. Assay performance was established using the Beckman Coulter AU480 chemistry analyzer.
1. Precision
Precision study was performed over 15 days, 2 runs per day with 2 collection devices per run (N=60),
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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
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 0 | -100% | 60 | 60 Negative |
| 7.5 | -75% | 60 | 60 Negative |
| 15 | -50% | 60 | 60 Negative |
| 22.5 | -25% | 60 | 60 Negative |
| 30 | Cutoff | 60 | 31 Neg/29 Pos |
| 37.5 | +25% | 60 | 60 Positive |
| 45 | +50% | 60 | 60 Positive |
| 52.5 | +75% | 60 | 60 Positive |
| 60 | +100% | 60 | 60 Positive |
Table 1. Precision – Qualitative - Quantisal
Table 2. Precision - Semi-Quantitative - Quantisal
| Concentration
(ng/mL) | % of
Cutoff | # of
Determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|---------------|
| 0 | -100% | 60 | -0.2 | 60 Negative |
| 15 | -50% | 60 | 16.7 | 60 Negative |
| 22.5 | -25% | 60 | 24.3 | 60 Negative |
| 30 | Cutoff | 60 | 32.3 | 16 Neg/44 Pos |
| 37.5 | +25% | 60 | 42.1 | 60 Positive |
| 45 | +50% | 60 | 53.3 | 60 Positive |
| 52.5 | +75% | 60 | 64.3 | 60 Positive |
| 60 | +100% | 60 | 76.3 | 60 Positive |
| Table 3. Precision - Qualitative - Quantisal II Pad A | ||||
|---|---|---|---|---|
| -- | -- | -- | ------------------------------------------------------- | -- |
| Concentration
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 0 | -100% | 60 | 60 Negative |
| 7.5 | -75% | 60 | 60 Negative |
| 15 | -50% | 60 | 60 Negative |
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| Concentration
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 22.5 | -25% | 60 | 60 Negative |
| 30 | Cutoff | 60 | 31 Neg/29 Pos |
| 37.5 | +25% | 60 | 60 Positive |
| 45 | +50% | 60 | 60 Positive |
| 52.5 | +75% | 60 | 60 Positive |
| 60 | +100% | 60 | 60 Positive |
Table 4. Precision - Semi-Quantitative – Quantisal II Pad A
| Concentration
(ng/mL) | % of
Cutoff | # of
Determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|---------------|
| 0 | -100% | 60 | 0.5 | 60 Negative |
| 7.5 | -75% | 60 | 7.3 | 60 Negative |
| 15 | -50% | 60 | 14.7 | 60 Negative |
| 22.5 | -25% | 60 | 21.7 | 60 Negative |
| 30 | Cutoff | 60 | 29.9 | 36 Neg/24 Pos |
| 37.5 | +25% | 60 | 42.4 | 60 Positive |
| 45 | +50% | 60 | 50.9 | 60 Positive |
| 52.5 | +75% | 60 | 57.3 | 60 Positive |
| 60 | +100% | 60 | 66.5 | 60 Positive |
Table 5. Precision - Qualitative - Quantisal II Pad B
| Concentration
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 0 | -100% | 60 | 60 Negative |
| 7.5 | -75% | 60 | 60 Negative |
| 15 | -50% | 60 | 60 Negative |
| 22.5 | -25% | 60 | 60 Negative |
| 30 | Cutoff | 60 | 28 Neg/32 Pos |
| 37.5 | +25% | 60 | 60 Positive |
| 45 | +50% | 60 | 60 Positive |
| 52.5 | +75% | 60 | 60 Positive |
| 60 | +100% | 60 | 60 Positive |
Table 6. Precision - Semi-Quantitative - Quantisal II Pad B
| Concentration
(ng/mL) | % of
Cutoff | # of
Determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|-------------|
| 0 | -100% | 60 | 0.3 | 60 Negative |
| 7.5 | -75% | 60 | 7.0 | 60 Negative |
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| Concentration
(ng/mL) | % of
Cutoff | # of
Determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|---------------|
| 15 | -50% | 60 | 14.9 | 60 Negative |
| 22.5 | -25% | 60 | 22.7 | 60 Negative |
| 30 | Cutoff | 60 | 30.8 | 28 Neg/32 Pos |
| 37.5 | +25% | 60 | 42.9 | 60 Positive |
| 45 | +50% | 60 | 49.4 | 60 Positive |
| 52.5 | +75% | 60 | 58.3 | 60 Positive |
| 60 | +100% | 60 | 67.1 | 60 Positive |
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 oxycodone assay to related drugs and drug metabolites, in both the qualitative and semiquantitative modes. Cross-reactivity test results in qualitative mode are presented in Table 7. Crossreactivity test results in semi-quantitative mode are presented in Table 8.
| Compound | Compound
Conc. (ng/mL) | Oxycodone
Equivalent
Conc. (ng/mL) | Result | Cross-
Reactivity (%) |
|----------------------------|---------------------------|------------------------------------------|--------|--------------------------|
| 6-acetylcodeine | 40,000 | 45 ng/mL
(greater than +50%
cutoff) | Agreement (%) | |
| Qual. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi-
Quant. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
Table 16. Method Comparison - Quantisal
Table 17. Method Comparison - Quantisal II "A"
| | Immunoassay
Result | LC-MS/MS Oxycodone Concentration | | | | |
|-----------------|-----------------------|---------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|------------------------------------------------|---------------|
| | | 45 ng/mL
(greater
than +50%
cutoff) | Agreement (%) |
| Qual. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi-
Quant. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
17
Image /page/17/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red, hexagon-shaped background. The word is written in all capital letters and is centered on the background. The background is a bright red color and has a slight gradient effect. The image is simple and clean, with a focus on the word "IMMUNALYSIS".
| LC-MS/MS Oxycodone Concentration | ||||||
|---|---|---|---|---|---|---|
| Immunoassay | ||||||
| Result | 45 ng/mL | |||||
| (greater | ||||||
| than +50% | ||||||
| cutoff) | Agreement (%) | |||||
| Positive | 0 | 0 | 5 | 35 | 100% (40/40) | |
| Qual. | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi- | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| Quant. | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
Table 18. Method Comparison – Quantisal II "B"
H. CONCLUSION
The information provided in this pre-market notification demonstrates that the SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its intended use.