(29 days)
The Cocaine Metabolite Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of benzoylecgonine in human urine, at the cutoff value of 150 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures.
The Cocaine Metabolite Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL.
The Cocaine Metabolite Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive
The Cocaine Metabolite assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, benzoylecgonine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound benzoylecgonine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The Cocaine Metabolite Enzyme Immunoassay is a kit comprised of two reagents, an R, and R2 which are bottled separately but sold together within the kit.
The Ri solution contains a mouse monoclonal anti-benzoylecgonine antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with benzoylecgonine in buffer with sodium azide (0.09%) as preservative.
The Cocaine Metabolite Enzyme Immunoassay calibrators and controls designated for use at the 150 ng/mL cutoff contain 0, 75, 112.5, 150, 187.5, 300, and 1000 ng/mL of benzoylecgonine in human urine with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
Here's a breakdown of the acceptance criteria and the study details for the Cocaine Metabolite Enzyme Immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state acceptance criteria in terms of numerical thresholds for each performance characteristic. However, it presents the performance data in a way that implies these results are deemed acceptable for demonstrating substantial equivalence to the predicate device. For qualitative analysis, the goal is typically high agreement with GC/MS, especially around the cutoff.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Semi-Quantitative) | Low %CV values, especially at and around the cutoff, indicating reproducibility. | Total Precision (%CV): |
| - 0 ng/mL: 156.9% | ||
| - 37.5 ng/mL: 10.8% | ||
| - 75 ng/mL: 7.4% | ||
| - 112.5 ng/mL: 4.3% | ||
| - 150 ng/mL: 4.7% | ||
| - 187.5 ng/mL: 4.0% | ||
| - 225 ng/mL: 4.1% | ||
| - 267.5 ng/mL: 3.4% | ||
| - 300 ng/mL: 3.7% | ||
| Qualitative Agreement (Clinical Samples vs. GC/MS) | High percentage agreement for both positive and negative samples compared to the confirmatory method. | Semi-Quantitative Data: 90% agreement with positive, 98% agreement with negative samples |
| Qualitative Data: 90% agreement with positive, 95% agreement with negative samples | ||
| Qualitative Positive/Negative Results (Concentration vs. Cutoff) | Consistent negative results for samples below the cutoff, consistent positive results for samples above the cutoff, with some variability expected at the cutoff. | Total Precision Immunoassay Result: |
| - 0, 37.5, 75, 112.5 ng/mL: 88 Negative | ||
| - 150 ng/mL: 15 Pos/73 Neg (Qualitative), 29 Pos/59 Neg (Semi-Qualitative) | ||
| - 187.5, 225, 267.5, 300 ng/mL: 88 Positive | ||
| Linearity | High correlation coefficient (r^2) with good agreement between observed and target values. | y = 1.0488x -0.5229, r^2 = 0.9992 |
| Endogenous Compound Interference & Specificity & Cross-Reactivity | No significant interference from common endogenous compounds or cross-reactants. | No significant undesired cross-reactants or endogenous substance interference was observed. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision/Qualitative Positive/Negative Results: The test set used for precision studies consisted of
N=88determinations at each specified concentration level. - Method Comparison - Clinical Samples:
Eighty (80)clinical unaltered samples were used. - Data Provenance: The document does not explicitly state the country of origin or whether the samples were retrospective or prospective. It only mentions "clinical unaltered samples."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. For an immunoassay of this type, the "ground truth" for clinical samples is typically established by Mass Spectrometry (GC/MS or LC/MS), which is an analytical method and doesn't require human expert interpretation in the same way an imaging study would.
4. Adjudication Method for the Test Set
- This information is not applicable and therefore not provided. The "adjudication method" typically refers to how disagreements among multiple human readers (e.g., radiologists) are resolved. For an immunoassay, the confirmatory method (GC/MS or LC/MS) establishes the objective truth.
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
- This information is not applicable and therefore not provided. This device is an immunoassay, not an AI-powered diagnostic imaging system that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Yes, this study is inherently a standalone performance evaluation of the immunoassay device. The results (e.g., precision, linearity, qualitative agreement against GC/MS) represent the performance of the device itself, without human interpretation of the assay result in a way that would modify the instrument's output. The output of the immunoassay is a numerical value or a positive/negative determination.
7. The Type of Ground Truth Used
- The ground truth for the clinical samples was established using a "more specific alternative chemical method," specifically Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS). This is explicitly stated as the "preferred confirmatory method."
8. The Sample Size for the Training Set
- This information is not applicable and therefore not provided. Immunoassays are not "trained" in the typical machine learning sense with a training dataset. Their performance is inherent to their chemical and biological design. The "calibration" mentioned refers to adjusting the instrument to known standard concentrations, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no "training set" in the context of a machine learning algorithm. The "Cocaine Metabolite Drugs of Abuse (DAU) Calibrators" are used for calibration, and their "ground truth" (i.e., their known concentrations) is established through controlled manufacturing processes and analytical verification.
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510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name, Address, and Contact
Lin-Zhi International, Inc. 670 Almanor Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 (408) 732-3849 Fax: e-mail: bclin@lin-zhi.com
Contact: Bernice Lin, Ph.D. VP Operations
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, CocaineClass II, DIO (91 Toxicology),21 CFR 862.3250Drug Specific Calibrators,Class II, DLJ (91 Toxicology),21 CFR 862.3200Drug Specific Controls,Class I, LAS (91 Toxicology),21 CFR 862.3280 |
|---|---|
| Common Name: | Homogeneous Cocaine Enzyme Immunoassay |
| Proprietary Name: | Cocaine Metabolite Enzyme Immunoassay,Cocaine Metabolite Drugs of Abuse (DAU) CalibratorsCocaine Metabolite Drugs of Abuse (DAU) Controls |
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Legally Marketed Predicate Device(s)
The Cocaine Metabolite Enzyme Immunoassay (EIA) at a cutoff of 150 ng/mL is substantially equivalent to the Cocaine Metabolite Enzyme Immunoassay (K020763), Calibrators and Controls for Hitachi 717 Systems (K020769) manufactured by Lin-Zhi International, Inc with a cutoff of 300 ng/mL. The Cocaine Metabolite Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
The Cocaine Metabolite assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, benzoylecgonine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound benzoylecgonine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The Cocaine Metabolite Enzyme Immunoassay is a kit comprised of two reagents, an R, and R2 which are bottled separately but sold together within the kit.
The Ri solution contains a mouse monoclonal anti-benzoylecgonine antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with benzoylecgonine in buffer with sodium azide (0.09%) as preservative.
The Cocaine Metabolite Enzyme Immunoassay calibrators and controls designated for use at the 150 ng/mL cutoff contain 0, 75, 112.5, 150, 187.5, 300, and 1000 ng/mL of benzoylecgonine in human urine with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
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Intended Use
The Cocaine Metabolite Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of benzoylecgonine in human urine, at a cutoff value of 150 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures.
The Cocaine Metabolite Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL.
The Cocaine Metabolite Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
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Comparison to Predicate Device
The Lin-Zhi International, Inc. Cocaine Metabolite Enzyme Immunoassay used at the 150 ng/mL cutoff is substantially equivalent to the Lin-Zhi International, Inc. Cocaine Metabolite Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems cleared by the FDA under the premarket notification K020763 and K020769 for its stated intended use.
The following table compares LZI's Cocaine Metabolite Enzyme Immunoassay at the 150 ng/mL cutoff with the predicate device.
| DeviceCharacteristics | Subject Device | Predicate Device (K020763 & K020769) |
|---|---|---|
| Intended Use | The Cocaine Metabolite EnzymeImmunoassay, when used in conjunctionwith Hitachi 717 automated clinicalsystem analyzers, is intended for thequalitative and semi-quantitativedetermination of benzoylecgonine inhuman urine, at a cutoff value of 150ng/mL. The assay is designed forprofessional use with a number ofautomated clinical chemistry analyzers.This assay provides a rapid screening procedurefor determining the presence of Benzoylecgoninein urine. The assay provides only a preliminaryanalytical result. A more specific alternativechemical method must be used in order to obtain aconfirmed analytical result. Gas or liquidchromatography/mass spectrometry (GC/MS orLC/MS) is the preferred confirmatory method.Clinical consideration and professional judgmentshould be exercised with any drug of abuse testresult, particularly when the preliminary test resultis positive. | The Cocaine Metabolite EnzymeImmunoassay from Lin-Zhi International,Inc., when used in conjunction withHitachi 717 automated clinical systemanalyzers, is intended for the qualitativeand semi-quantitative determination ofbenzoylecgonine in human urine, at acutoff value of 300 ng/mL. The assay isdesigned for professional use with anumber of automated clinical chemistryanalyzers.This assay provides a rapid screening procedurefor determining the presence of Benzoylecgoninein urine. The assay provides only a preliminaryanalytical result. A more specific alternativechemical method must be used in order to obtain aconfirmed analytical result. Gas or liquidchromatography/mass spectrometry (GC/MS orLC/MS) is the preferred confirmatory method.Clinical consideration and professional judgmentshould be exercised with any drug of abuse testresult, particularly when the preliminary test resultis positive. |
| Analyte | Benzoylecgonine | Benzoylecgonine |
| Cutoff | 150 ng/ml | 300 ng/mL |
| Matrix | Urine | Urine |
| CalibratorsLevel | 5 Levels(0, 75, 150, 300, 1000 ng/mL) | 5 Levels(0, 150, 300, 1000, 3000 ng/mL) |
| Controls Level | 2 Levels(112.5 ng/mL, 187.5 ng/mL) | 2 Levels(225 ng/mL, 375 ng/mL) |
| Storage | 2-8 °C until expiration date | 2-8 °C until expiration date |
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Performance Characteristics Summary: Hitachi 717 Analyzer
Precision:
Precision: Semi-Quantitative, ng/mL
| N=88(ng/mL) | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| Mean | SD | % CV | Mean | SD | % CV | |
| 0 ng/mL | 1.7 | 2.2 | n/a | 1.7 | 2.7 | 156.9 |
| 37.5 ng/mL | 40.4 | 3.8 | 9.3 | 40.4 | 4.4 | 10.8 |
| 75 ng/mL | 76.9 | 4.2 | 5.4 | 76.9 | 5.7 | 7.4 |
| 112.5 ng/mL | 111.6 | 4.1 | 3.7 | 111.6 | 4.8 | 4.3 |
| 150 ng/mL | 146.2 | 5.9 | 4.1 | 146.2 | 6.8 | 4.7 |
| 187.5 ng/mL | 185.1 | 6.3 | 3.4 | 185.1 | 7.5 | 4.0 |
| 225 ng/mL | 224.0 | 9.0 | 4.0 | 224.0 | 9.1 | 4.1 |
| 267.5 ng/mL | 263.4 | 7.8 | 3.0 | 263.4 | 8.9 | 3.4 |
| 300 ng/mL | 301.9 | 9.4 | 3.1 | 301.9 | 11.2 | 3.7 |
Semi-Quantitative Precision Analysis Summary: Qualitative Results
:
| N=88 | (ng/mL) | Within Run | Total Precision | ||
|---|---|---|---|---|---|
| Mean | Qualitative Response | Mean | Qualitative Response | ||
| 0 ng/mL | 1.7 | - | 1.7 | - | |
| 37.5 ng/mL | 40.4 | - | 40.4 | - | |
| 75 ng/mL | 76.9 | - | 76.9 | - | |
| 112.5 ng/mL | 111.6 | - | 111.6 | - | |
| 150 ng/mL | 146.2 | - | 146.2 | - | |
| 187.5 ng/mL | 185.1 | + | 185.1 | + | |
| 225 ng/mL | 224.0 | + | 224.0 | + | |
| 267.5 ng/mL | 263.4 | + | 263.4 | + | |
| 300 ng/mL | 301.9 | + | 301.9 | + |
Semi-Quantitative Positive/Negative Results:
| 150 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| SampleConcentration | % of Cutoff | Number ofDetermination | ImmunoassayResult | Number ofDetermination | ImmunoassayResult |
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 37.5 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 112.5 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 150 ng/mL | 0% | 22 | 3 Pos/19 Neg | 88 | 29 Pos/ 59 Neg |
| 187.5 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 225 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 267.5 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 300 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
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Performance Characteristics Summary: continued Hitachi 717 Analyzer
| N=88 | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| (mA/min) | Mean | SD | % CV | Mean | SD | % CV |
| 0 ng/mL | 373.5 | 3.1 | 0.8 | 373.5 | 5.0 | 1.3 |
| 37.5 ng/mL | 407.2 | 2.8 | 0.7 | 407.2 | 3.8 | 0.9 |
| 75 ng/mL | 437.2 | 3.3 | 0.7 | 437.2 | 4.6 | 1.1 |
| 112.5 ng/mL | 462.6 | 2.8 | 0.6 | 462.6 | 4.5 | 1.0 |
| 150 ng/mL | 486.0 | 3.7 | 0.8 | 486.0 | 4.6 | 0.9 |
| 187.5 ng/mL | 509.6 | 3.0 | 0.6 | 509.6 | 4.3 | 0.9 |
| 225 ng/mL | 528.9 | 4.5 | 0.9 | 528.9 | 5.0 | 0.9 |
| 267.5 ng/mL | 544.8 | 3.4 | 0.6 | 544.8 | 4.6 | 0.8 |
| 300 ng/mL | 560.8 | 3.6 | 0.6 | 560.8 | 4.7 | 0.8 |
Precision: Qualitative, mA/min
Qualitative Positive/Negative Results:
| 150 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| SampleConcentration | % of Cutoff | Number ofDetermination | ImmunoassayResult | Number ofDetermination | ImmunoassayResult |
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 37.5 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 75 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 112.5 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 150 ng/mL | 0% | 22 | 3 Pos/19 Neg | 88 | 15 Pos/73 Neg |
| 187.5 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 225 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 267.5 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 300 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
Linearity:
Hitachi 717 Instrument: 0 - 1000 ng/mL
When comparing the result (y) and target (x) value, using the least squares regression technique, the regression equation and correlation are as follow: y = 1.0488x -0.5229, r4=0.9992
Method Comparison - Clinical Samples:
From a total of eighty (80) clinical unaltered samples
Semi-Quantitative Data: 90% agreement with positive, 98% agreement with negative samples Qualitative Data: 90% agreement with positive, 95% agreement with negative samples
Endogenous Compound Interference & Specificity & Cross-Reactivity:
No significant undesired cross reactants or endogenous substance interference was observed.
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Performance Characteristics Summary: continued Hitachi 717 Analyzer
Summary:
The information provided in this pre-market notification demonstrates that the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL is substantially equivalent to the legally marketed predicate device for its general intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by chromatography/mass spectrometry (GC/MS or LC/MS), an independent analytical method. The information supplied in this premarket notification provides reasonable assurance that the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL is safe and effective for its stated intended use.
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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is depicted in a simple, abstract style, with flowing lines suggesting movement. The text is in a sans-serif font and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/7/Picture/4 description: The image shows a date, "NOV 22 2011". The month is November, the day is the 22nd, and the year is 2011. The text is in a bold, sans-serif font. The text is black against a white background.
LIN-ZHI INTERNATIONAL, INC c/o Bernice Lin. PHD VP Operations 670 Almanor Ave Sunnyvale, California 94085
.
Re: K113139
Trade Name: LZI Cocaine Metabolite Homogeneous Enzyme Immunoassay, Cocaine Metabolite Drugs of Abuse Calibrators and Controls Regulation Number: 21 CFR §862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Codes: DIO, DLJ, LAS Dated: October 21, 2011 Received: October 24, 2011
Dear Bernice Lin:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K113139
Device Name: Cocaine Metabolite Enzyme Immunoassay Cocaine Metabolite Calibrators and Controls
Indications for Use:
The Cocaine Metabolite Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of benzoylecgonine in human urine, at the cutoff value of 150 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures.
The Cocaine Metabolite Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL.
The Cocaine Metabolite Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive
Prescription Use __ __ AND/OR Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) (Per 21 CFR 801.109)
Signature
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113134
§ 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).