(267 days)
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.
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
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the method comparison studies. However, the reported "Result" for agreement percentages can be interpreted as the performance achieved. Similarly, for precision studies, "Results" indicate the number of negative/positive determinations. For linearity, it's % recovery.
Table 1: Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|---|
| Method Comparison (Qualitative & Semi-Quantitative) | |||
| 150 ng/mL Cutoff | High agreement with GC/MS | 91% agreement | The document does not specify a numerical threshold for "high agreement." |
| 300 ng/mL Cutoff | High agreement with GC/MS | 88% agreement | The document does not specify a numerical threshold for "high agreement." |
| Precision (Qualitative & Semi-Quantitative) | |||
| 150 ng/mL Cutoff | |||
| 0 ng/mL | 100% Negative | 80 Negative | Achieved |
| 38 ng/mL (-75%) | 100% Negative | 80 Negative | Achieved |
| 75 ng/mL (-50%) | 100% Negative | 80 Negative | Achieved |
| 113 ng/mL (-25%) | 100% Negative | 80 Negative | Achieved |
| 150 ng/mL (Cutoff) | Consistent classification (~50% Positive/Negative) | 9 Negative / 71 Positive | At the cutoff, some variability in classification is expected. The exact split for "acceptance" isn't defined but this is a common observation. |
| 188 ng/mL (+25%) | 100% Positive | 80 Positive | Achieved |
| 225 ng/mL (+50%) | 100% Positive | 80 Positive | Achieved |
| 263 ng/mL (+75%) | 100% Positive | 80 Positive | Achieved |
| 300 ng/mL (+100%) | 100% Positive | 80 Positive | Achieved |
| 300 ng/mL Cutoff | |||
| 0 ng/mL | 100% Negative | 80 Negative | Achieved |
| 75 ng/mL (-75%) | 100% Negative | 80 Negative | Achieved |
| 150 ng/mL (-50%) | 100% Negative | 80 Negative | Achieved |
| 225 ng/mL (-25%) | 100% Negative | 80 Negative | Achieved |
| 300 ng/mL (Cutoff) | Consistent classification (~50% Positive/Negative) | 54 Negative / 26 Positive | At the cutoff, some variability in classification is expected. |
| 375 ng/mL (+25%) | 100% Positive | 80 Positive | Achieved |
| 450 ng/mL (+50%) | 100% Positive | 80 Negative (This appears to be an error in the document, should likely be positive) | Note: The document states 80 Negative for +50% of 300 ng/mL cutoff (450 ng/mL) which is contradictory to expectation for a positive result above cutoff. This might be a typo in the provided text. Based on other results, it should be 80 Positive. |
| 525 ng/mL (+75%) | 100% Positive | 80 Positive | Achieved |
| 600 ng/mL (+100%) | 100% Positive | 80 Positive | Achieved |
| Recovery/Linearity (Semiquantitative) | |||
| % Recovery | Not explicitly stated (e.g., ±X%) | Ranges from -0.7% to 8.6% | The document does not specify an acceptance range for % Recovery (e.g., 90-110%). |
| Specificity - Structurally Related Compounds | |||
| Cross-Reactivity | Low cross-reactivity for non-benzoylecgonine compounds | Ecgonine: 2-3%, Cocaine: 0.5%, others <0.01% | The document lists values but does not define an explicit acceptance criteria (e.g., <5% for non-target compounds). |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison:
- 150 ng/mL Cutoff: n = 102 native patient urine samples.
- 300 ng/mL Cutoff: n = 95 native patient urine samples.
- Data Provenance: Retrospective, as indicated by "native patient urine samples." The country of origin is not specified.
- Precision (Repeatability and Within-Lab Precision):
- Sample Size: 9 sample levels for each cutoff (150 ng/mL and 300 ng/mL). Each level was determined 80 times (20 days, 2 runs/day, 2 replicates/run). This implies 9 * 80 = 720 individual determinations per cutoff, across the various concentrations.
- Data Provenance: The samples were "prepared by spiking," implying laboratory-controlled samples, not native patient samples. Data provenance (country of origin) is not specified.
- Recovery/Linearity:
- Sample Size: Two aliquots of negative urine pool spiked to create samples. Five replicates were tested at each of the 10 concentration levels. This implies 5 * 10 = 50 individual determinations.
- Data Provenance: Laboratory-prepared samples, not native patient samples. Data provenance (country of origin) is not specified.
- Specificity - Structurally Related Compounds:
- Sample Size: Not explicitly stated as a "sample size" for a study, but rather concentrations at which various compounds were tested for cross-reactivity.
- Data Provenance: Laboratory-controlled testing, not native patient samples. Data provenance (country of origin) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The ground truth for the test set (Method Comparison) was established by Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is an analytical chemistry technique, not a human expert. Therefore, the concept of "number of experts" and their "qualifications" is not applicable in this context.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by an objective analytical method (GC/MS), not through human interpretation or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic assay (an enzyme immunoassay) designed to detect a cocaine metabolite in urine. It does not involve human readers for interpretation, nor does it incorporate AI in a way that would assist human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance studies described (Method Comparison, Precision, Recovery/Linearity, Specificity) represent standalone performance of the device (assay on the analyzer). The results are generated directly by the Emit® II Plus Cocaine Metabolite Assay on the Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer, without human interpretive input. The output is a qualitative (positive/negative) or semi-quantitative result.
7. The Type of Ground Truth Used
The primary ground truth used for the method comparison study was Gas Chromatography/Mass Spectrometry (GC/MS). For precision, linearity, and specificity studies, the ground truth was based on known concentrations of the analyte in prepared samples.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. This is a traditional in vitro diagnostic device, not an AI/ML-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" described for this device.
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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
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (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
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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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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
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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 CocaineMetabolite Assay(K993988) | Emit II Plus CocaineMetabolite Assay(Proposed) |
|---|---|---|
| Intended Use | The Emit® II Plus CocaineMetabolite Assay is ahomogeneous enzymeimmunoassay with a 150 ng/mL(SAMHSA initial test cutoff level)or 300 ng/mL cutoff. The assayis intended for use in thequalitative and semiquantitativeanalyses of benzoylecgonine(cocaine metabolite) in humanurine. Emit® II Plus assays aredesigned for use with a numberof chemistry analyzers.The Emit® II Plus CocaineMetabolite Assay provides onlya preliminary analytical testresult. A more specificalternative chemical methodmust be used to obtain aconfirmed analytical result. Gaschromatography/massspectrometry (GC/MS) is the | The Emit® II Plus CocaineMetabolite Assay is ahomogeneous enzymeimmunoassay with a 150 ng/mLor 300 ng/mL cutoff. The assayis intended for use in thequalitative and semiquantitativeanalyses of benzoylecgonine(cocaine metabolite) in humanurine. Emit® II Plus assays aredesigned for use with a numberof chemistry analyzers.The Emit® II Plus CocaineMetabolite Assay provides onlya preliminary analytical testresult. A more specificalternative chemical methodmust be used to obtain aconfirmed analytical result. Gaschromatography/massspectrometry (GC/MS) is thepreferred confirmatory method. |
7. Comparison of Technological Characteristics with the Predicate Device
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SIER
| Attribute | Emit II Plus CocaineMetabolite Assay(K993988) | Emit II Plus CocaineMetabolite Assay(Proposed) |
|---|---|---|
| preferred confirmatory method.Other chemical confirmationmethods are available. Clinicalconsideration and professionaljudgment should be applied toany drug-of-abuse test result,particularly when preliminarypositive results are used. | Other chemical confirmationmethods are available. Clinicalconsideration and professionaljudgment should be applied toany drug-of-abuse test result,particularly when preliminarypositive results are used. | |
| Measurand | Benzoylecgonine | Same |
| Type of Test | Qualitative and semi-quantitativehomogeneous enzymeimmunoassay | Same |
| Antibody | Sheep polyclonal | Same |
| Reagent Form | Liquid, ready to use | Same |
| ReagentComposition | Antibody/Substrate Reagent 1Sheep polyclonal antibodies tobenzoylecgonine (2.2 µg/mL),bovine serum albumin, G6P(15 mM), NAD (12 mM),preservatives, and stabilizersEnzyme Reagent 2Benzoylecgonine labeled withbacterial G6PDH (0.46 U/mL),HEPES buffer, bovine serumalbumin, preservatives, andstabilizers | 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.
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| GC/MS | |||||
|---|---|---|---|---|---|
| Negative(<75 ng/mL) | Negative(75 - 149 ng/mL) | Positive(150 - 225 ng/mL) | Positive(> 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 PlusCocaine MetaboliteAssay (pos/neg) | GC/MS(ng/mL) | Major Drug Present byGC/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 PlusCocaine MetaboliteAssay (pos/neg) | GC/MS(ng/mL) | Major Drug Present byGC/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(<150 ng/ml) | Negative(150 - 299 ng/mL) | Positive(300 - 450 ng/mL) | Positive(> 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
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| Emit II PlusCocaine MetaboliteAssay (pos/neg) | GC/MS(ng/mL) | Major Drug Present byGC/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 PlusCocaine MetaboliteAssay (pos/neg) | GC/MS(ng/mL) | Major Drug Present byGC/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.
| BenzoylecgonineConcentration(ng/mL) | % ofcutoff | # ofdeterminations | RepeatabilityResult | Within-LabResult |
|---|---|---|---|---|
| 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 Negative71 Positive | 9 Negative71 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
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SIEMENS
| BenzoylecgonineConcentration(ng/mL) | % ofcutoff | # ofdeterminations | RepeatabilityResult | Within-LabResult |
|---|---|---|---|---|
| 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 Negative71 Positive | 9 Negative71 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
| BenzoylecgonineConcentration(ng/mL) | % ofcutoff | # ofdeterminations | RepeatabilityResult | Within-LabResult |
|---|---|---|---|---|
| 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 Negative26 Positive | 54 Negative26 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
| BenzoylecgonineConcentration(ng/mL) | % ofcutoff | # ofdeterminations | RepeatabilityResult | Within-LabResult |
|---|---|---|---|---|
| 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 Negative26 Positive | 54 Negative26 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 |
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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.
| NominalBenzoylecgonine (ng/mL) | Mean MeasuredBenzoylecgonine (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 | <0.01% |
| Cocaethylene | 100,000 | <0.01% |
| Ecgonine Methyl Ester | 100,000 | <0.01% |
Table 8.4(b) Structurally Related Compounds, 300 ng/mL cutoff
| Compound | Concentration Tested(ng/mL) | % Cross-Reactivity |
|---|---|---|
| Ecgonine* | 15,000 | 2% |
| Cocaine* | 61,000 | 0.5% |
| Norcocaine | 100,000 | <0.01% |
| Cocaethylene | 100,000 | <0.01% |
| Ecgonine Methyl Ester | 100,000 | <0.01% |
*Ecgonine and cocaine tested at the concentrations above produced a result approximately equivalent to the cutoff.
9. Conclusion
The information presented in this premarket notification demonstrates that the Emit® II Plus Cocaine Metabolite Assay is substantially equivalent to the legally marketed predicate device identified above.
§ 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).