(23 days)
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No
The device description and performance studies detail a standard enzyme immunoassay method for detecting oxycodone. There is no mention of AI, ML, or any computational methods beyond basic data analysis for performance evaluation.
No.
This device is an in vitro diagnostic assay used for the qualitative and semiquantitative determination of oxycodone in human urine. It provides analytical test results, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "The assay is intended for in vitro diagnostic use."
No
The device is a homogeneous enzyme immunoassay kit consisting of liquid reagents in plastic containers, which are physical components, not software. While it is designed for use with chemistry analyzers (which likely involve software), the device itself is a chemical assay kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the assay is "intended for in vitro diagnostic use in the qualitative and semiquantitative determination of oxycodone in human urine." This is the primary indicator of an IVD.
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses reagents to analyze a human biological sample (urine) to detect a substance (oxycodone). This aligns with the definition of an IVD.
- Clinical Chemistry Analyzers: The assay is designed for use with "clinical chemistry analyzers," which are instruments commonly used in clinical laboratories for diagnostic testing.
- Preliminary Analytical Test Result: While the assay provides a preliminary result and requires confirmation, this is a common characteristic of screening IVDs. The purpose is to identify potential positives for further investigation.
- Performance Studies: The document describes performance evaluations including method comparison with a confirmatory method (LC-MS/MS), precision, recovery, and interference studies. These are standard studies conducted for IVDs to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K040411) indicates that this device is being compared to a previously cleared IVD by a regulatory body (likely the FDA in the US).
All these factors strongly indicate that the Emit II Plus Oxycodone Assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Emit II Plus Oxycodone Assay is a homogeneous enzyme immunoassay with 100 ng/mL cutoff. The assay is intended for in vitro diagnostic use in the qualitative and semiquantitative determination of oxycodone in human urine. The Emit II Plus Oxycodone Assay is designed for use with a number of clinical chemistry analyzers. The semiquantitative mode is for the purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Mass Spectrometry (LC/MS) or permitting laboratories to establish quality control procedures.
The Emit II Plus Oxycodone Assay provides only a preliminary analytical test result. A more specific alternative chemical method(s) must be used to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS) and LC/MS are the preferred confirmatory methods. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
The Emit® II Plus Oxycodone assay is a homogeneous enzyme immunoassay with 100 ng/mL and 300 ng/mL cutoffs. The assay, used for the detection of oxycodone in human urine, utilizes a two- reagent system. The Antibody/Substrate Reagent 1 is a liquid ready-to-use product comprised of mouse monoclonal antibodies to oxycodone, qucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in a diluent containing bovine serum albumin (BSA), preservatives and stabilizers. The Enzyme Reagent 2 is a liquid, ready-to-use product containing oxymorphone labeled with bacterial recombinant glucose-6 phosphate dehydrogenase (rG6PDH) in a diluent containing bovine serum albumin (BSA), HEPES buffer, preservatives and stabilizers.
The assay kit consists of Reagent 1 and Reagent 2 in plastic containers and is available in three sizes: 1000 mL/500 mL, 115 mL/50 mL, and 28 mL/14 mL. Emit® II Plus assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Oxycodone assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A total of 100 unaltered native patient samples were tested for each cutoff. Samples were evaluated using the Emit® II Plus Oxycodone Assay on the Viva-E® instrument and Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Evaluation:
(i) Method Comparison: 100 unaltered native patient samples for each cutoff. Agreement among positives is 52/56 = 93% and agreement among negatives is 44/44 = 100% for the 100 ng/mL cutoff (both qualitative and semiquantitative modes). For the 300 ng/mL cutoff, agreement among positives is 44/45 = 98% and agreement among negatives is 54/55 = 98% for qualitative mode; agreement among positives is 44/45 = 98% and agreement among negatives is 55/55 = 100% for semiquantitative mode.
(ii) Precision: Repeatability and Within-Lab Precision were determined by assaying urine pools spiked with oxycodone at nine different levels for each cutoff. Testing sequence for each level consisted of two replicates, twice a day, for twenty days (n = 80) for each cutoff. Precision data were evaluated according to CLSI Guideline EP05-A3.
(iii) Recovery: Oxycodone samples prepared by spiking known levels of oxycodone into drug-free urine. 7 concentrations evaluated for 100 ng/mL cutoff (replicates of 5); 13 concentrations for 300 ng/mL cutoff (replicates of 5). Mean recovery for 100 ng/mL ranged from 96% to 120%. Mean recovery for 300 ng/mL ranged from 96% to 105%.
(iv) Oxycodone Metabolites: Evaluated by dose-response to determine the level that would give a response approximately equivalent to the cutoff response. Percent cross-reactivity calculated according to CLSI EP07-A2.
(v) Structurally Related Compounds: Structurally similar drugs spiked into drug-free urine and percent cross-reactivity evaluated at both cutoffs according to CLSI EP07-A2.
(vi) Structurally Unrelated Compounds: Interference of structurally unrelated compounds and common over the counter drugs evaluated qualitatively and semiquantitatively according to CLSI EP07-A2. Spiked into two levels of controls at +/- 25% of the cutoff concentration. No false response observed.
(vii) Endogenous Substances: Evaluated qualitatively and semiquantitatively according to CLSI EP07-A2. Spiked into two levels of controls at +/- 25% of the cutoff concentration. No false response observed.
(viii) Specific Gravity and pH: Drug free urine pools with specific gravity values from 1.002 to 1.035 and pH values from 3.0 to 11.0 were prepared and spiked to final concentrations of 75 ng/mL, 125 ng/mL and 375 ng/mL oxycodone. No positive or negative interference observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Method Comparison (100 ng/mL cutoff):
Qualitative Mode: Agreement among positives is 52/56 = 93%, Agreement among negatives is 44/44 = 100%.
Semiquantitative Mode: Agreement among positives is 52/56 = 93%, Agreement among negatives is 44/44 = 100%.
Method Comparison (300 ng/mL cutoff):
Qualitative Mode: Agreement among positives is 44/45 = 98%, Agreement among negatives is 54/55 = 98%.
Semiquantitative Mode: Agreement among positives is 44/45 = 98%, Agreement among negatives is 55/55 = 100%.
Precision (100 ng/mL Cutoff):
For Quantitative mode at 100 ng/mL: 78 Positive / 2 Negative for 100 ng/mL level (80 total).
For Semiquantitative mode at 100 ng/mL: 78 Positive / 2 Negative for 100 ng/mL level (80 total).
Precision (300 ng/mL Cutoff):
For Qualitative mode at 300 ng/mL: 76 Positive / 4 Negative for 300 ng/mL level (80 total).
For Semiquantitative mode at 300 ng/mL: 64 Positive / 16 Negative for 300 ng/mL level (80 total).
Recovery (100 ng/mL Cutoff):
Target Concentration (ng/mL) / Mean Recovery (%):
50 / 120
75 / 105
100 / (Value missing from table)
125 / 98
200 / 98
300 / 102
400 / (Value missing from table)
Recovery (300 ng/mL Cutoff):
Target Concentration (ng/mL) / Mean Recovery (%):
100 / 101
150 / 97
200 / 96
225 / 96
300 / 101
375 / 100
400 / 104
500 / 105
600 / 104
700 / 103
800 / 100
900 / 99
1000 / 97
Cross-Reactivity (100 ng/mL cutoff):
Oxycodone: 100.0%
Oxymorphone: 84.0%
Oxymorphone-3-beta-glucuronide: 5.9%
Noroxycodone: 0.9%
Noroxymorphone: 0.3%
Cross-Reactivity (300 ng/mL cutoff):
Oxycodone: 96.8%
Oxymorphone: 75.0%
Oxymorphone-3-beta-glucuronide: 5.2%
Noroxycodone: 0.9%
Noroxymorphone: 0.4%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2017
SIEMENS HEALTHCARE DIAGNOSTICS INC. ALAN HALEY REGULATORY AND CLINICAL AFFAIRS SPECIALIST 500 GBC DRIVE, M/S 514 NEWARK, DE 19702
Re: K172910
Trade/Device Name: Emit II Plus Oxycodone Assay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG Dated: September 21, 2017 Received: September 25, 2017
Dear Alan Haley:
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
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172910
Device Name Emit II Plus Oxycodone Assay
Indications for Use (Describe)
The Emit II Plus Oxycodone Assay is a homogeneous enzyme immunoassay with 100 ng/mL cutoff. The assay is intended for in vitro diagnostic use in the qualitative and semiquantitative determination of oxycodone in human urine. The Emit II Plus Oxycodone Assay is designed for use with a number of clinical chemistry analyzers. The semiquantitative mode is for the purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Mass Spectrometry (LC/MS) or permitting laboratories to establish quality control procedures.
The Emit II Plus Oxycodone Assay provides only a preliminary analytical test result. A more specific alternative chemical method(s) must be used to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS) and LC/MS are the preferred confirmatory methods. Clinical consideration and professional judgement should be applied to any drug-of-abuse 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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3
SIEMI
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of Safe Medical Device Act of 1990 and 21 CFR 807.92.
1. Submitter
| Company | Siemens Healthcare Diagnostics Inc. |
|---|---|
| Address | 500 GBC Drive, M/S 514 Newark, DE 19702 |
| Contact | Alan Haley |
| Telephone | 302.631.9883 |
| Fax | 302.631.6299 |
| Date of Preparation | October 16, 2017 |
2. Device Information
| Trade Name | Emit® II Plus Oxycodone Assay |
|---|---|
| Common Name | Enzyme Immunoassay, Opiates |
| Classification Name | Opiate Test System |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class II |
| Product Code | DJG |
3. Identification of Predicate
| Trade Name | DRI Oxycodone Assay |
|---|---|
| 510(k) Submitter | Microgenics Corp. |
| 510(k) Number | K040411 |
| Clearance Date | May 27, 2004 |
Device Description 4.
The Emit® II Plus Oxycodone assay is a homogeneous enzyme immunoassay with 100 ng/mL and 300 ng/mL cutoffs. The assay, used for the detection of oxycodone in human urine, utilizes a two- reagent system. The Antibody/Substrate Reagent 1 is a liquid ready-to-use product comprised of mouse monoclonal antibodies to oxycodone, qucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in a diluent containing bovine serum albumin (BSA), preservatives and stabilizers. The Enzyme Reagent 2 is a liquid, ready-to-use product containing oxymorphone labeled with bacterial recombinant glucose-6 phosphate dehydrogenase (rG6PDH) in a diluent containing bovine serum albumin (BSA), HEPES buffer, preservatives and stabilizers.
The assay kit consists of Reagent 1 and Reagent 2 in plastic containers and is available in three sizes: 1000 mL/500 mL, 115 mL/50 mL, and 28 mL/14 mL. Emit® II Plus assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Oxycodone assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result.
4
SIEMENS
5. Intended Use Statement
The Emit® II Plus Oxycodone Assay is a homogeneous enzyme immunoassay with 100 ng/mL and 300 ng/mL cutoffs. The assay is intended for in vitro diagnostic use in the qualitative and semiguantitative determination of oxycodone in human urine. The Emit® II Plus Oxycodone Assay is designed for use with a number of clinical chemistry analyzers. The semiquantitative mode is for the purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liguid Chromatography/Mass Spectrometry (LC/MS) or permitting laboratories to establish quality control procedures.
The Emit® II Plus Oxycodone Assay provides only a preliminary analytical test result. A more specific alternative chemical method(s) must be used to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS) and LC/MS are the preferred confirmatory methods. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
6. Technological Characteristics
(a) Comparison to Predicate
| ltem | DRI Oxycodone Assay
(K040411) | Emit® II Plus Oxycodone Assay
(Proposed) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Intended Use | The DRI® Oxycodone assay is
intended to be used for the qualitative
and semi-quantitative determination of
the presence of oxycodone in human
urine at cutoffs of 100 ng/mL and
300 ng/mL. | Same |
| Analyte | Oxycodone | Same |
| Matrix | Urine | Same |
| Storage | 2°C to 8°C until expiration date | Same |
| Type of Test | Homogeneous enzyme
immunoassay | Same |
| Reagent Form | Liquid, Ready to Use | Same |
| Reagent
Composition | Antibody/substrate reagent and
enzyme conjugate/reagent. The
antibody substrate reagent includes
mouse monoclonal anti-oxycodone
derivative antibody, glucose-6-
phosphate and NAD in buffer with
preservative. The enzyme conjugate
reagent includes oxycodone derivative
labeled with glucose-6-phosphate
dehydrogenase in buffer with
preservative. | Same |
| Cutoffs | 100 ng/mL oxycodone
300 ng/mL oxycodone | Same |
5
SIEMEN
(b) Non-Clinical Performance Evaluation
The data that appear in this section were collected on the Viva-E® Analyzer using the Emil® II Plus Oxycodone Assay. Summary results for each study are provided. The results represent typical assay performance.
(i) Method Comparison
A total of 100 unaltered native patient samples were tested for each cutoff. Samples were evaluated using the Emit® II Plus Oxycodone Assay on the Viva-E® instrument and Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).
Results for the 100 ng/mL assay cutoff are presented below:
| Table A. Method Comparison Results (100 ng/mL Cutoff) | |||
|---|---|---|---|
| LC-MS/MS | |||||
|---|---|---|---|---|---|
| Low Negative | |||||
| (Less than 50% below the cutoff concentration) | Near Cutoff Negative | ||||
| (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive | ||||
| (Between the cutoff and 50% above the cutoff concentration) | High Positive | ||||
| (greater than 50% above the cutoff concentration) | |||||
| Qualitative Mode | |||||
| Emit® | Positive | 0 | 0 | 9 | 43 |
| Negative | 31 | 13 | 4 | 0 | |
| Agreement among positives is 52/56 = 93% | |||||
| Agreement among negatives is 44/44 = 100% | |||||
| Semiquantitative Mode | |||||
| Emit® | Positive | 0 | 0 | 9 | 43 |
| Negative | 31 | 13 | 4 | 0 | |
| Agreement among positives is 52/56 = 93% | |||||
| Agreement among negatives is 44/44 = 100% |
Table B. Discordant Results (100 ng/mL Cutoff)
| Emit® | LC-MS/MS | |||
|---|---|---|---|---|
| Sample # | Semiquantitative | |||
| (ng/mL) | Qualitative | |||
| (Pos/Neg) | Oxycodone | |||
| (ng/mL) | Oxymorphone | |||
| (ng/mL) | ||||
| OXY-471 | 85 | Neg | 100 | 0 |
| OXY-9128 | 90 | Neg | 102 | 0 |
| OXY-9129 | 96 | Neg | 103 | 0 |
| OXY-9130 | 93 | Neg | 103 | 0 |
6
Results for the 300 ng/mL assay cutoff are presented below.
Table C. Method Comparison Results (300 ng/mL Cutoff)
| LC-MS/MS | |||||
|---|---|---|---|---|---|
| Low Negative | |||||
| (Less than 50% below the cutoff concentration) | Near Cutoff Negative | ||||
| (Between 50% below the cutoff and the cutoff concentration)) | Near Cutoff Positive | ||||
| (Between the cutoff and 50% above the cutoff concentration) | High Positive | ||||
| (greater than 50% above the cutoff concentration) | |||||
| Qualitative Mode | |||||
| Emit® | Positive | 0 | 1 | 11 | 33 |
| Emit® | Negative | 42 | 12 | 1 | 0 |
| Agreement among positives is 44/45 = 98% | |||||
| Agreement among negatives is 54/55 = 98% | |||||
| Semiquantitative Mode | |||||
| Emit® | Positive | 0 | 0 | 11 | 33 |
| Emit® | Negative | 42 | 13 | 1 | 0 |
| Agreement among positives is 44/45 = 98% | |||||
| Agreement among negatives is 55/55 = 100% |
Table D. Discordant Results (300 ng/mL Cutoff)
| Sample # | Emit® | LC-MS/MS | ||
|---|---|---|---|---|
| Semiquantitative (ng/mL) | Qualitative (Pos/Neg) | Oxycodone (ng/mL) | Oxymorphone (ng/mL) | |
| OXY-161 | 263 | Neg | 318 | 0 |
| OXY-665 | 288 | Pos | 182 | 29.1 |
(ii) Precision
Repeatability and Within-Lab Precision were determined by assaying urine pools spiked with oxycodone at nine different levels for each cutoff. The testing sequence for each level consisted of two replicates, twice a day, for twenty days (n = 80) for each cutoff. Precision data were evaluated according to the Clinical and Laboratory Standards Institute (CLSI) Guideline EP05-A3.
Table E. Precision (100 ng/mL Cutoff)
| Urine Pool | % of | # of | Qualitative | Semiquantitative | ||
|---|---|---|---|---|---|---|
| (ng/mL) | Cutoff | Results | Repeatability | Within-Lab | Repeatability | Within-Lab |
| 0 | -100 | 80 | 80 Negative | 80 Negative | 80 Negative | 80 Negative |
| 25 | -75 | 80 | 80 Negative | 80 Negative | 80 Negative | 80 Negative |
| 50 | -50 | 80 | 80 Negative | 80 Negative | 80 Negative | 80 Negative |
| 75 | -25 | 80 | 80 Negative | 80 Negative | 80 Negative | 80 Negative |
| 80 | 2 Negative/ | 2 Negative/ | 2 Negative/ | 2 Negative/ | ||
| 100 | Cutoff | 78 Positive | 78 Positive | 78 Positive | 78 Positive | |
| 80 Positive | ||||||
| 80 Positive | ||||||
| 80 Positive | ||||||
| 80 Positive | ||||||
| 125 | +25 | 80 | 80 Positive | 80 Positive | 80 Positive | |
| 150 | +50 | 80 | 80 Positive | 80 Positive | 80 Positive | |
| 175 | +75 | 80 | 80 Positive | 80 Positive | 80 Positive | |
| 200 | +100 | 80 | 80 Positive | 80 Positive | 80 Positive |
7
| Urine Pool
(ng/mL) | % of
Cutoff | # of
Results | Qualitative | | Semiquantitative | |
|-----------------------|----------------|-----------------|----------------------------|----------------------------|-----------------------------|-----------------------------|
| 0 | -100 | 80 | 80 Negative | 80 Negative | 80 Negative | 80 Negative |
| 75 | -75 | 80 | 80 Negative | 80 Negative | 80 Negative | 80 Negative |
| 150 | -50 | 80 | 80 Negative | 80 Negative | 80 Negative | 80 Negative |
| 225 | -25 | 80 | 80 Negative | 80 Negative | 80 Negative | 80 Negative |
| 300 | Cutoff | 80 | 4 Negative/
76 Positive | 4 Negative/
76 Positive | 16 Negative/
64 Positive | 16 Negative/
64 Positive |
| 375 | +25 | 80 | 80 Positive | 80 Positive | 80 Positive | 80 Positive |
| 450 | +50 | 80 | 80 Positive | 80 Positive | 80 Positive | 80 Positive |
| 525 | +75 | 80 | 80 Positive | 80 Positive | 80 Positive | 80 Positive |
| 600 | +100 | 80 | 80 Positive | 80 Positive | 80 Positive | 80 Positive |
Table F. Precision (300 ng/mL cutoff)
(iii) Recovery
Oxycodone samples were prepared by spiking known levels of oxycodone into drug-free urine. A total of 7 concentrations were evaluated for oxycodone at the 100 ng/mL cutoff and 13 concentrations were evaluated for oxycodone at the 300 ng/mL cutoff. Spiked samples were analyzed in replicates of 5. Results are shown in Table G for the 100 ng/mL cutoff; Table H for the 300 ng/mL cutoff.
Table G. Recovery Results (100 ng/mL Cutoff)
| Target
Concentration
(ng/mL) | Mean Measured
Concentration
(ng/mL) | Mean
Recovery (%) |
|------------------------------------|-------------------------------------------|----------------------|
| 50 | 60 | 120 |
| 75 | 79 | 105 |
| 100 | વેદ | વેદ |
| 125 | 123 | ರಿ8 |
| 200 | 196 | ರಿ8 |
| 300 | 306 | 102 |
| 400 | 385 | વેદ |
Table H. Recovery Results (300 ng/mL Cutoff)
| Target
Concentration
(ng/mL) | Mean Measured
Concentration
(ng/mL) | Mean
Recovery (%) |
|------------------------------------|-------------------------------------------|----------------------|
| 100 | 101 | 101 |
| 150 | 145 | 97 |
| 200 | 191 | 96 |
| 225 | 216 | 96 |
| 300 | 304 | 101 |
| 375 | 374 | 100 |
| 400 | 414 | 104 |
| 500 | 525 | 105 |
| 600 | 621 | 104 |
| 700 | 723 | 103 |
| 800 | 803 | 100 |
| 900 | 893 | 99 |
| 1000 | 969 | 97 |
8
SIEMEN
(iv) Oxycodone Metabolites
Oxycodone metabolites were spiked into negative urine and evaluated by dose-response to determine the level that would give a response approximately equivalent to the cutoff response. Percent cross-reactivity was calculated according to CLSI EP07-A2.
Table I. Oxycodone Metabolite Cross-Reactivity (100 ng/mL cutoff)
| Compound | Concentration
(ng/mL) | % Cross-
Reactivity |
|---------------------------------|--------------------------|------------------------|
| Oxycodone | 100 | 100.0 |
| Oxymorphone | 119 | 84.0 |
| Oxymorphone-3-β-
glucuronide | 1,700 | 5.9 |
| Noroxycodone | 11,000 | 0.9 |
| Noroxymorphone | 31,000 | 0.3 |
Table J. Oxycodone Metabolite Cross-Reactivity (300 ng/mL cutoff)
| Compound | Concentration
(ng/mL) | % Cross-
Reactivity |
|---------------------------------|--------------------------|------------------------|
| Oxycodone | 310 | 96.8 |
| Oxymorphone | 400 | 75.0 |
| Oxymorphone-3-β-
glucuronide | 5,800 | 5.2 |
| Noroxycodone | 35,000 | 0.9 |
| Noroxymorphone | 81,000 | 0.4 |
(v) Structurally Related Compounds
Structurally similar drugs were spiked into drug-free urine and percent cross-reactivity was evaluated at both cutoffs according to CLSI EP07-A2. Drugs eliciting a positive response were evaluated by doseresponse to determine the lowest level of cross-reactant that would generate a positive result relative to the cutoff.
| Table K. Structurally Related Compounds (100 ng/mL Cutoff) | ||
|---|---|---|
| -- | ------------------------------------------------------------ | -- |
| Compound | Concentration
(ng/mL) | % Cross-
Reactivity |
|--------------------------------|--------------------------|------------------------|
| 6-Acetylcodeine | 100,000 | 0.01 |
| 6-Acetylmorphine | 100,000 | 0.01 |
| Buprenorphine | 100,000 | 0.01 |
| Codeine | 340,000 | 0.03 |
| Dextromethorphan | 200,000 |