(267 days)
Not Found
No
The device description and performance studies detail a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic (IVD) assay designed to detect cocaine metabolites in human urine. It provides analytical test results for diagnostic purposes and does not provide therapeutic benefits or treatment.
Yes
Explanation: The device, the Emit® II Plus Cocaine Metabolite Assay, is intended for "qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine." This analysis provides preliminary analytical test results for a specific biomarker related to drug use, which directly aligns with the function of a diagnostic device.
No
The device description clearly outlines the components of the assay as two ready-to-use reagents (Antibody/Substrate Reagent 1 and Enzyme Reagent 2), which are physical substances, not software. The assay relies on a chemical reaction and spectrophotometric measurement, indicating a hardware component (chemistry analyzer) is required for its use.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine." This involves testing a sample taken from the human body in vitro (outside the body) to provide information about a physiological state (presence of a drug metabolite).
- Device Description: The description details a "homogeneous enzyme immunoassay" that measures a substance in a biological sample (urine). This is a common type of IVD technology.
- Sample Type: The assay uses "human urine," which is a biological specimen.
- Purpose: The purpose is to detect the presence of a drug metabolite, which is a diagnostic or screening function.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Cocaine Metabolite Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Product codes
DIO
Device Description
The Emit II Plus Cocaine Metabolite assay is a homogeneous enzyme immunoassay that qualitatively and semiquantitatively measures benzoylecgonine. The assay has cutoffs of 150 ng/mL and 300 ng/mL benzoylecgonine.
The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm.
The Emit II Plus Cocaine Metabolite Assay consists of two ready-to-use reagents:
Antibody/Substrate Reagent 1
Sheep polyclonal antibodies to benzoylecgonine (2.2 µg/mL), bovine serum albumin, G6P (15 mM), NAD (12 mM), preservatives, and stabilizers
Enzyme Reagent 2
Benzoylecgonine labeled with bacterial G6PDH (0.46 U/mL), HEPES buffer, bovine serum albumin, preservatives, and stabilizers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
8.1 Method Comparison
Study type: Method Comparison
Sample size: 102 (for 150 ng/mL cutoff), 95 (for 300 ng/mL cutoff)
Key results:
150 ng/mL Cutoff: 91% agreement with GC/MS.
300 ng/mL Cutoff: 88% agreement with GC/MS.
8.2 Repeatability and Within-Lab Precision
Study type: Precision study (Repeatability and Within-Lab Precision)
Sample size: 80 determinations for each level (9 sample levels for each cutoff)
Key results:
150 ng/mL Cutoff Qualitative and Semi-Quantitative: At the 150 ng/mL cutoff, 9 Negative and 71 Positive results were obtained out of 80 determinations. Other concentrations showed 80 Negative or 80 Positive results consistently.
300 ng/mL Cutoff Qualitative and Semi-Quantitative: At the 300 ng/mL cutoff, 54 Negative and 26 Positive results were obtained out of 80 determinations. Other concentrations showed 80 Negative or 80 Positive results consistently.
8.3 Recovery/Linearity
Study type: Recovery/Linearity
Sample size: Five replicates at each of 10 measured benzoylecgonine concentrations.
Key results: Percentage recovery ranged from -0.7% to 8.6% across the tested concentrations (50 ng/mL to 1000 ng/mL).
8.4 Specificity - Structurally Related Compounds
Study type: Specificity (Cross-Reactivity)
Key results:
150 ng/mL cutoff: Ecgonine showed 3% cross-reactivity, Cocaine showed 0.5% cross-reactivity. Norcocaine, Cocaethylene, and Ecgonine Methyl Ester showed
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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 features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2017
SIEMENS HEALTHCARE DIAGNOSTICS INC. ALAN HALEY REGULATORY CLINICAL AFFAIRS SPECIALIST 500 GBC Drive, M/S 514 NEWARK, DE. 19702
Re: K170293
Trade/Device Name: Emit II Plus Cocaine Metabolite Assay Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO Dated: October 16, 2017 Received: October 17, 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) K170293
Device Name Emit® II Plus Cocaine Metabolite Assay
Indications for Use (Describe)
The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Cocaine Metabolite Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment 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
SIEMEN?
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.
The assigned 510(k) number is K170293
1. Submitter
Company Siemens Healthcare Diagnostics Inc.
500 GBC Drive, M/S 514 Newark, DE 19702 Address
Contact Alan Haley
302.631.9883 Telephone
302.631.6299 Fax
Date of Preparation 2.
October 24, 2017
3. Device Information
| Trade Name | Emit® II Plus Cocaine Metabolite Assay |
|---|---|
| Common Name | Cocaine Metabolite Assay |
| Classification Name | Enzyme Immunoassay, Cocaine and Cocaine Metabolites |
| Regulation | 21 CFR 862.3250 |
| Device Class | Class II |
| Product Code | DIO |
4. Indications for Use
The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiguantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Cocaine Metabolite Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred
confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
5. Device Description
The Emit II Plus Cocaine Metabolite assay is a homogeneous enzyme immunoassay that qualitatively and semiquantitatively measures benzoylecgonine. The assay has cutoffs of 150 ng/mL and 300 ng/mL benzoylecgonine.
The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can
4
SIEMEN?
be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm.
The Emit II Plus Cocaine Metabolite Assay consists of two ready-to-use reagents:
Antibody/Substrate Reagent 1
Sheep polyclonal antibodies to benzoylecgonine (2.2 µg/mL), bovine serum albumin, G6P (15 mM), NAD (12 mM), preservatives, and stabilizers
Enzvme Reagent 2
Benzoylecgonine labeled with bacterial G6PDH (0.46 U/mL), HEPES buffer, bovine serum albumin, preservatives, and stabilizers
Medical Device to Which Equivalence is Claimed 6.
The Siemens Healthcare Diagnostics Inc. Emit® II Plus Cocaine Metabolite Assay has the same intended use and indications for use as the Emit II Plus Cocaine Metabolite Assay previously cleared under 510(k) K993988 (January 27, 2000). Siemens Healthcare Diagnostics provides instructions for using this assay on a number of chemistry analyzers.
The predicate and proposed device were considered side to examine the similarities and differences between the devices.
| Attribute | Emit II Plus Cocaine
Metabolite Assay
(K993988) | Emit II Plus Cocaine
Metabolite Assay
(Proposed) |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Emit® II Plus Cocaine
Metabolite Assay is a
homogeneous enzyme
immunoassay with a 150 ng/mL
(SAMHSA initial test cutoff level)
or 300 ng/mL cutoff. The assay
is intended for use in the
qualitative and semiquantitative
analyses of benzoylecgonine
(cocaine metabolite) in human
urine. Emit® II Plus assays are
designed for use with a number
of chemistry analyzers.
The Emit® II Plus Cocaine
Metabolite Assay provides only
a preliminary analytical test
result. A more specific
alternative chemical method
must be used to obtain a
confirmed analytical result. Gas
chromatography/mass
spectrometry (GC/MS) is the | The Emit® II Plus Cocaine
Metabolite Assay is a
homogeneous enzyme
immunoassay with a 150 ng/mL
or 300 ng/mL cutoff. The assay
is intended for use in the
qualitative and semiquantitative
analyses of benzoylecgonine
(cocaine metabolite) in human
urine. Emit® II Plus assays are
designed for use with a number
of chemistry analyzers.
The Emit® II Plus Cocaine
Metabolite Assay provides only
a preliminary analytical test
result. A more specific
alternative chemical method
must be used to obtain a
confirmed analytical result. Gas
chromatography/mass
spectrometry (GC/MS) is the
preferred confirmatory method. |
7. Comparison of Technological Characteristics with the Predicate Device
5
SIER
| Attribute | Emit II Plus Cocaine
Metabolite Assay
(K993988) | Emit II Plus Cocaine
Metabolite Assay
(Proposed) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | preferred confirmatory method.
Other chemical confirmation
methods are available. Clinical
consideration and professional
judgment should be applied to
any drug-of-abuse test result,
particularly when preliminary
positive results are used. | Other chemical confirmation
methods are available. Clinical
consideration and professional
judgment should be applied to
any drug-of-abuse test result,
particularly when preliminary
positive results are used. |
| Measurand | Benzoylecgonine | Same |
| Type of Test | Qualitative and semi-quantitative
homogeneous enzyme
immunoassay | Same |
| Antibody | Sheep polyclonal | Same |
| Reagent Form | Liquid, ready to use | Same |
| Reagent
Composition | Antibody/Substrate Reagent 1
Sheep polyclonal antibodies to
benzoylecgonine (2.2 µg/mL),
bovine serum albumin, G6P
(15 mM), NAD (12 mM),
preservatives, and stabilizers
Enzyme Reagent 2
Benzoylecgonine labeled with
bacterial G6PDH (0.46 U/mL),
HEPES buffer, bovine serum
albumin, preservatives, and
stabilizers | Same |
| Cutoffs/Controls | 150 ng/mL (±25%)
300ng/mL (±25%) | Same |
| Sample Matrix | Human Urine | Same |
8. Performance Data
The following tests were conducted to assess the critical performance parameters of the Emit® II Plus Cocaine Metabolite assay on the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer.
8.1 Method Comparison
The benzoylecgonine values of native patient urine samples were measured using the Emit® II Plus Cocaine Metabolite assay on the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer (proposed) and were compared to the values measured using GC/MS.
6
| GC/MS | |||||
|---|---|---|---|---|---|
| Negative | |||||
| ( 225 ng/mL) | |||||
| Qualitative | |||||
| DxC | Positive | 2 | 7 | 10 | 51 |
| 700 AU | Negative | 28 | 4 | 0 | 0 |
| Semi-Quantitative | |||||
| DxC | Positive | 2 | 7 | 10 | 51 |
| 700 AU | Negative | 28 | 4 | 0 | 0 |
Table 8.1(a) Method Comparison Results for the 150 ng/mL Cutoff (n = 102)
Result: 91% agreement
Table 8.1(b) Summary of Discordant Results, 150 ng/mL cutoff, Qualitative
| Emit II Plus
Cocaine Metabolite
Assay (pos/neg) | GC/MS
(ng/mL) | Major Drug Present by
GC/MS |
|-------------------------------------------------------|------------------|--------------------------------|
| Positive | 124 | Benzoylecgonine |
| Positive | 34 | Benzoylecgonine |
| Positive | 73 | Benzoylecgonine |
| Positive | 83 | Benzoylecgonine |
| Positive | 102 | Benzoylecgonine |
| Positive | 80 | Benzoylecgonine |
| Positive | 105 | Benzoylecgonine |
| Positive | 101 | Benzoylecgonine |
| Positive | 75 | Benzoylecgonine |
Table 8.1(c) Summary of Discordant Results, 150 ng/mL cutoff, Semi-Quantitative
| Emit II Plus
Cocaine Metabolite
Assay (pos/neg) | GC/MS
(ng/mL) | Major Drug Present by
GC/MS |
|-------------------------------------------------------|------------------|--------------------------------|
| Positive | 124 | Benzoylecgonine |
| Positive | 34 | Benzoylecgonine |
| Positive | 73 | Benzoylecgonine |
| Positive | 83 | Benzoylecgonine |
| Positive | 102 | Benzoylecgonine |
| Positive | 80 | Benzoylecgonine |
| Positive | 105 | Benzoylecgonine |
| Positive | 101 | Benzoylecgonine |
| Positive | 75 | Benzoylecgonine |
Table 8.1(d) Method Comparison Results for the 300 ng/mL Cutoff (n = 95)
| GC/MS | |||||
|---|---|---|---|---|---|
| Negative | |||||
| ( 450 ng/mL) | |||||
| Qualitative | |||||
| DxC | Positive | 1 | 10 | 18 | 25 |
| 700 AU | Negative | 40 | 1 | 0 | 0 |
| Semi-Quantitative | |||||
| DxC | Positive | 1 | 10 | 18 | 25 |
| 700 AU | Negative | 40 | 1 | 0 | 0 |
Result: 88% agreement
7
| Emit II Plus
Cocaine Metabolite
Assay (pos/neg) | GC/MS
(ng/mL) | Major Drug Present by
GC/MS |
|-------------------------------------------------------|------------------|--------------------------------|
| Positive | 217 | Benzoylecgonine |
| Positive | 240 | Benzoylecgonine |
| Positive | 173 | Benzoylecgonine |
| Positive | 207 | Benzoylecgonine |
| Positive | 233 | Benzoylecgonine |
| Positive | 143 | Benzoylecgonine |
| Positive | 217 | Benzoylecgonine |
| Positive | 173 | Benzoylecgonine |
| Positive | 232 | Benzoylecgonine |
| Positive | 157 | Benzoylecgonine |
| Positive | 234 | Benzoylecgonine |
Table 8.1(e) Summary of Discordant Results, 300 ng/mL cutoff, Qualitative
Table 8.1(f) Summary of Discordant Results, 300 ng/mL cutoff, Semi-Quantitative
| Emit II Plus
Cocaine Metabolite
Assay (pos/neg) | GC/MS
(ng/mL) | Major Drug Present by
GC/MS |
|-------------------------------------------------------|------------------|--------------------------------|
| Positive | 217 | Benzoylecgonine |
| Positive | 240 | Benzoylecgonine |
| Positive | 173 | Benzoylecgonine |
| Positive | 207 | Benzoylecgonine |
| Positive | 233 | Benzoylecgonine |
| Positive | 143 | Benzoylecgonine |
| Positive | 217 | Benzoylecgonine |
| Positive | 173 | Benzoylecgonine |
| Positive | 232 | Benzoylecgonine |
| Positive | 157 | Benzoylecgonine |
| Positive | 234 | Benzoylecgonine |
8.2 Repeatability and Within-Lab Precision
A precision study was performed for 20 days, 2 runs per day, 2 replicates per run per day (N=80). Nine sample levels were tested for each cutoff : equal to the cutoff, ± 25% of the cutoff, ± 50% of the cutoff, ± 75% of the cutoff, and ±100% of the cutoff. Data were analyzed using a nested, two factor (days and runs nested within days) ANOVA model. Testing was performed on a Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer.
| Benzoylecgonine
Concentration
(ng/mL) | % of
cutoff | # of
determinations | Repeatability
Result | Within-Lab
Result |
|---------------------------------------------|----------------|------------------------|---------------------------|---------------------------|
| 0 | -100% | 80 | 80 Negative | 80 Negative |
| 38 | -75% | 80 | 80 Negative | 80 Negative |
| 75 | -50% | 80 | 80 Negative | 80 Negative |
| 113 | -25% | 80 | 80 Negative | 80 Negative |
| 150 | Cutoff | 80 | 9 Negative
71 Positive | 9 Negative
71 Positive |
| 188 | +25% | 80 | 80 Positive | 80 Positive |
| 225 | +50% | 80 | 80 Positive | 80 Positive |
| 263 | +75% | 80 | 80 Positive | 80 Positive |
| 300 | 100% | 80 | 80 Positive | 80 Positive |
Table 8.2(a) Precision, Qualitative, 150 ng/mL Cutoff
8
SIEMENS
| Benzoylecgonine
Concentration
(ng/mL) | % of
cutoff | # of
determinations | Repeatability
Result | Within-Lab
Result |
|---------------------------------------------|----------------|------------------------|---------------------------|---------------------------|
| 0 | -100% | 80 | 80 Negative | 80 Negative |
| 38 | -75% | 80 | 80 Negative | 80 Negative |
| 75 | -50% | 80 | 80 Negative | 80 Negative |
| 113 | -25% | 80 | 80 Negative | 80 Negative |
| 150 | Cutoff | 80 | 9 Negative
71 Positive | 9 Negative
71 Positive |
| 188 | +25% | 80 | 80 Positive | 80 Positive |
| 225 | +50% | 80 | 80 Positive | 80 Positive |
| 263 | +75% | 80 | 80 Positive | 80 Positive |
| 300 | 100% | 80 | 80 Positive | 80 Positive |
Table 8.2(b) Precision. Semi-Quantitative. 150 ng/mL Cutoff
Table 8.2(c) Precision, Qualitative, 300 ng/mL Cutoff
| Benzoylecgonine
Concentration
(ng/mL) | % of
cutoff | # of
determinations | Repeatability
Result | Within-Lab
Result |
|---------------------------------------------|----------------|------------------------|----------------------------|----------------------------|
| 0 | -100% | 80 | 80 Negative | 80 Negative |
| 75 | -75% | 80 | 80 Negative | 80 Negative |
| 150 | -50% | 80 | 80 Negative | 80 Negative |
| 225 | -25% | 80 | 80 Negative | 80 Negative |
| 300 | Cutoff | 80 | 54 Negative
26 Positive | 54 Negative
26 Positive |
| 375 | +25% | 80 | 80 Positive | 80 Positive |
| 450 | +50% | 80 | 80 Negative | 80 Negative |
| 525 | +75% | 80 | 80 Positive | 80 Positive |
| 600 | +100% | 80 | 80 Positive | 80 Positive |
Table 8.2(d) Precision, Semi-Quantitative, 300 ng/mL Cutoff
| Benzoylecgonine
Concentration
(ng/mL) | % of
cutoff | # of
determinations | Repeatability
Result | Within-Lab
Result |
|---------------------------------------------|----------------|------------------------|----------------------------|----------------------------|
| 0 | -100% | 80 | 80 Negative | 80 Negative |
| 75 | -75% | 80 | 80 Negative | 80 Negative |
| 150 | -50% | 80 | 80 Negative | 80 Negative |
| 225 | -25% | 80 | 80 Negative | 80 Negative |
| 300 | Cutoff | 80 | 54 Negative
26 Positive | 54 Negative
26 Positive |
| 375 | +25% | 80 | 80 Positive | 80 Positive |
| 450 | +50% | 80 | 80 Negative | 80 Negative |
| 525 | +75% | 80 | 80 Positive | 80 Positive |
| 600 | +100% | 80 | 80 Positive | 80 Positive |
9
SIEME
8.3 Recovery/Linearity
Samples were prepared by spiking two aliguots of negative urine pool with known concentrations of benzoylecqonine and sequentially mixing them to create samples across the analytical range. Five replicates were tested at each level. Testing was performed on a Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer.
| Nominal
Benzoylecgonine (ng/mL) | Mean Measured
Benzoylecgonine (ng/mL) | % Recovery |
|------------------------------------|------------------------------------------|------------|
| 50 | 53 | 6.1% |
| 100 | 103 | 3.1% |
| 150 | 150 | 0.2% |
| 225 | 235 | 4.3% |
| 300 | 298 | -0.7% |
| 375 | 380 | 1.4% |
| 500 | 543 | 8.6% |
| 750 | 792 | 5.6% |
| 900 | 906 | 0.6% |
| 1000 | 1029 | 2.9% |
Table 8.3(a) Recovery/Linearity. Semiquantitative
8.4 Specificity - Structurally Related Compounds
The Emit® II Plus Cocaine Metabolite Assay detects benzoylecgonine, the major metabolite of cocaine, in human urine. Tables 8.4(a) and 8.4(b) list the cross-reactivity for structurally related compounds. Data presented are representative of typical performance of this assay.
Table 8.4(a) Structurally Related Compounds, 150 ng/mL cutoff
| Compound | Concentration Tested
(ng/mL) | % Cross-Reactivity |
|-----------------------|---------------------------------|--------------------|
| Ecgonine* | 5,000 | 3% |
| Cocaine* | 29,000 | 0.5% |
| Norcocaine | 100,000 |