(41 days)
The LZI Methamphetamine Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of d-methamphetamine in human urine, at a cutoff value of 500 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 and LCMS or (2) permitting laboratories to establish quality control procedures.
The LZI Methamphetamine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Methamphetamine Enzyme Immunoassay at a cutoff value of 500 ng/mL.
The LZI Methamphetamine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Methamphetamine Enzyme Immunoassay at a cutoff value of 500 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 LZI Methamphetamine Enzyme Immunoassay 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, methamphetamine-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 methamphetamine-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 LZI Methamphetamine Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The R1 solution contains mouse monoclonal anti-methamphetamine antibody, glucose-6-phosphate (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 d-methamphetamine in buffer with sodium azide (0.09%) as a preservative.
The LZI Methamphetamine Enzyme Immunoassay calibrators and controls designated for use at the 500 ng/mL cutoff contain 0, 250, 375, 500, 625, 1000, and 2000 ng/mL of d-methamphetamine in human urine with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
The LZI Methamphetamine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of d-methamphetamine in human urine, at a cutoff value of 500 ng/mL. The assay provides only a preliminary analytical result, and a more specific alternative chemical method (e.g., GC/MS or LC/MS) is required for confirmation.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as separate targets in the document. However, the performance characteristics demonstrated serve as the basis for establishing substantial equivalence. The document primarily focuses on precision (intra-run and total precision) and method comparison (agreement with GC/MS or LC/MS). Based on the provided data, we can infer the expected performance.
| Performance Metric | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (LZI Methamphetamine EIA) |
|---|---|---|
| Precision (Semi-Quantitative, % CV) | Low %CV, indicating good reproducibility. | Ranges from 1.1% to 1.7% (Total Precision) |
| Precision (Qualitative, Qualitative Response Agreement for samples at 500 ng/mL cutoff) | High agreement (e.g., 95% or higher) with expected positive/negative results. | Total Precision: 85 Positive / 3 Negative at 500 ng/mL (96.6% positive agreement expected to be positive for the 500 ng/mL samples) |
| Agreement with Confirmatory Method (Clinical Samples - Semi-Quantitative) | High agreement (e.g., 95% or higher) with GC/MS or LC/MS. | 97.87% agreement with positive samples, 100% agreement with negative samples. |
| Agreement with Confirmatory Method (Clinical Samples - Qualitative) | High agreement (e.g., 95% or higher) with GC/MS or LC/MS. | 97.87% agreement with positive samples, 100% agreement with negative samples. |
| Limit of Detection | Ability to differentiate from negative urine with 95% confidence. | 25 ng/mL |
| Linearity (0 - 2000 ng/mL) | High correlation (r²) close to 1.0. | y = 0.9791x - 2.8289, r² = 0.9996 |
| Endogenous Compound Interference & Specificity & Cross-Reactivity | No significant undesired interference 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 Test Set: The number of determinations (N) for precision studies was 88 (for total precision) and 22 (for within-run precision) for each concentration level tested (0, 125, 250, 375, 500, 625, 750, 875, 1000 ng/mL).
- Method Comparison - Clinical Samples Test Set: 95 clinical unaltered samples were used.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for either the precision studies or clinical sample method comparison. It is implied to be prospective testing for device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There were no human experts validating the test set for this device in the traditional sense of image or clinical interpretation. The ground truth for the test set (e.g., actual methamphetamine concentration in urine) would have been established by a validated reference method, referred to as Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS). The qualifications of individuals performing these confirmatory tests are not specified but would typically be trained laboratory personnel.
4. Adjudication Method for the Test Set
Not applicable. This is a laboratory immunoassay device, and "adjudication" in the context of expert consensus is not relevant. The ground truth is determined by the reference analytical method (GC/MS or LC/MS).
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
Not applicable. This is an immunoassay device, not a device involving human readers or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance characteristics presented (Precision, Limit of Detection, Linearity, Method Comparison) represent the standalone performance of the LZI Methamphetamine Enzyme Immunoassay system on the Hitachi 717 Analyzer, without human intervention in result interpretation beyond routine laboratory operations.
7. The Type of Ground Truth Used
The ground truth used for establishing the performance of the device, particularly for method comparison, is a confirmatory chemical analytical method, specifically Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS). This is a highly accurate and specific method for determining drug concentrations.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of an algorithm or machine learning. This is a traditional immunoassay device. The described performance studies are for validation of the device. If the question implicitly refers to samples used during assay development and optimization, that information is not provided in this summary.
9. How the Ground Truth for the Training Set was Established
As this is a traditional immunoassay and not an AI/ML device, the concept of a "training set" with ground truth established for it in the same way is not directly applicable. If one were to interpret "training" as the development and optimization of the assay itself, the internal standards and reference materials used for assay development would have had their concentrations established through precise chemical methods, likely including GC/MS or LC/MS, to ensure accuracy.
{0}------------------------------------------------
JAN 2 3 2012
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
Bernice Lin, Ph D. Contact: VP Operations
Device Name and Classification
Classification Name:
Methamphetamine Test System Class II, LAF (91 Toxicology), 21 CFR 862.3610
Drug Specific Calibrators, Class IL DLJ (91 Toxicology), 21 CFR 862.3200
Drug Specific Controls. Class I, LAS (91 Toxicology), 21 CFR 862.3280
Common Name: Proprietary Name: Homogeneous Methamphetamine Enzyme Immunoassay LZI Methamphetamine Enzyme Immunoassay, LZI Methamphetamine Drugs of Abuse (DAU) Calibrators LZI Methamphetamine Drugs of Abuse (DAU) Controls
{1}------------------------------------------------
Legally Marketed Predicate Device(s)
The LZI Methamphetamine Enzyme Immnoassay (EIA) at a cutoff of 500 ng/mL i substantially equivalent to the Amphetamines 500 Enzyme Immunoassay and Amphetamine 500 Calibrators and Controls for Hitachi 717 Systems (K102210) manufactured by Lin-Zh International. Inc with a cutoff of 500 ng/mL. The LZI Methamphetamine Enzym Immunoassay is identical or similar to its predicate in terms of intended use, method principle device components, and clinical performance.
Device Description
The LZI Methamphetamine Enzyme Immunoassay is a homogeneous enzyme inimunoassa" with ready-to-use liguid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-o-phosphate dehydrogenase (GoPDH) for : 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. II the absence of drug in the sample, methamphetamine-labeled G6PDH comugate 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 methamphetamine-labeled G6PDF then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenin dimucleotide (NAD) to NADH, resulting in an absorbance change that can be measure spectrophotometrically at 340 mm.
The LZI Methamphetamine Enzyme Immunoassay is a kit comprised of two reagents, an R and R3 which are bottled separately but sold together within the kit.
The R. solution contains mouse monoclonal anti-methamphetamine antibody, glucose-6 phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azid (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate debydrogenas (G6PDH) labeled with d-methamphetamine in buffer with sodium azide (0.09%) a preservative.
The LZI Methamphetamine Enzyme Immunoassay calibrators and controls designated for use at the 500 ng/mL cutoff contain 0, 250, 375, 500, 625, 1000, and 2000 ng/mL of dmethamphetamine in human urine with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
{2}------------------------------------------------
Intended Use
The LZI Methamphetamine Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of d-methamphetamine in human urine, at a cutoff value of 500 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 and LCMS or (2) permitting laboratories to establish quality control procedures.
The LZI Methamphetamine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Methamphetamine Enzyme Immmoassay at a cutoff value of 500 ng/mL.
The LZI Methamphetamine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Methamphetamine Enzyme Immunoassay at a cutoff value of 500 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 lignid 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.
{3}------------------------------------------------
Comparison to Predicate Device
The Lin-Zhi International, Inc. (LZ) Methamphetamine Enzyme Immunoassay used at the 500 ng/mL cutoff is substantially equivalent to the Lin-Zhi International, Inc. Amphetamines 500 Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems cleared by the FDA under the premarket notification K102210 for its stated intended use.
The following table compares LZI's Methamphetamine Enzyme Immunoassay at the 500 ng/mL cutoff with the predicate device.
| DeviceCharacteristics | Subject Device | Predicate Device (K102210) |
|---|---|---|
| LZI Methamphetamine EnzymeImmunoassay | Amphetamines 500 EnzymeImmunoassay, Calibrators and Controls | |
| Intended Use | The LZI Methamphetamine EnzymeImmunoassay, when used in conjunctionwith Hitachi 717 automated clinicalsystem analyzers, is intended for thequalitative and semi-quantitativedetermination of methamphetamine inhuman urine, at a cutoff value of 500ng/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 d-methamphetamine in urine. The assay providesonly a preliminary analytical result. A morespecific alternative chemical method must be usedin order to obtain a confirmed analytical result.Gas or liquid chromatography/mass spectrometry(GC/MS or LC/MS) is the preferred confirmatorymethod. Clinical consideration and professionaljudgment should be exercised with any drug ofabuse test result, particularly when the preliminarytest result is positive. | The Amphetamines 500 EnzymeImmunoassay from Lin-Zhi International,Inc., when used in conjunction withHitachi 717 automated clinical systemanalyzers is intended for the qualitativeand semi-quantitative determination ofamphetamine and methamphetamine inhuman urine, at a cutoff value of 500ng/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 d-methamphetamine and d-amphetamine in urine.The assay provides only a preliminary analyticalresult. A more specific alternative chemicalmethod 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 | d-methamphetamine | d-methamphetamine &d-amphetamine |
| Cutoff | 500 ng/ml | 500 ng/mL |
| Matrix | Urine | Urine |
| CalibratorsLevel | 5 Levels(0, 250, 500, 1000, 2000 ng/mL) | 5 Levels(0, 250, 500, 1000, 2000 ng/mL) |
| Controls Level | 2 Levels(375 ng/mL, 625 ng/mL) | 2 Levels(375 ng/mL, 625 ng/mL) |
| Storage | 2-8 °C until expiration date | 2-8 °C until expiration date |
{4}------------------------------------------------
Performance Characteristics Summary: Hitachi 717 Analyzer
Precision:
Precision: Semi-Quantitative, ng/mL
| N=88 | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| (ng/mL) | Mean | SD | % CV | Mean | SD | % CV |
| 0 ng/mL | 6.0 | 4.82 | 87.5% | 6.0 | 5.5 | 91.6% |
| 125 ng/mL | 112.3 | 2.74 | 2.4% | 112.3 | 4.0 | 3.6% |
| 250 ng/mL | 249.6 | 2.79 | 1.1% | 249.6 | 4.6 | 1.9% |
| 375 ng/mL | 387.1 | 4.57 | 1.2% | 387.1 | 5.4 | 1.4% |
| 500 ng/mL | 513.5 | 6.05 | 1.2% | 513.5 | 8.3 | 1.6% |
| 625 ng/mL | 635.6 | 7.47 | 1.2% | 635.6 | 9.6 | 1.5% |
| 750 ng/mL | 751.0 | 8.14 | 1.1% | 751.0 | 12.1 | 1.6% |
| 875 ng/mL | 868.4 | 11.90 | 1.4% | 868.4 | 14.9 | 1.7% |
| 1000 ng/mL | 987.7 | 11.25 | 1.1% | 987.7 | 15.2 | 1.5% |
Semi-Quantitative Precision Analysis Summary: Qualitative Results
| N=88(ng/mL) | Mean | Within RunQualitative Response | Mean | Total PrecisionQualitative Response |
|---|---|---|---|---|
| 0 ng/mL | 6.0 | - | 6.0 | - |
| 125 ng/mL | 112.3 | - | 112.3 | - |
| 250 ng/mL | 249.6 | - | 249.6 | - |
| 375 ng/mL | 387.1 | - | 387.1 | - |
| 500 ng/mL | 513.5 | + | 513.5 | + |
| 625 ng/mL | 635.6 | + | 635.6 | + |
| 750 ng/mL | 751.0 | + | 751.0 | + |
| 875 ng/mL | 868.4 | + | 868.4 | + |
| 1000 ng/mL | 987.7 | + | 987.7 | + |
| 500 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 |
| 125 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 250 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 375 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 500 ng/mL | 0% | 22 | 22 Positive | 88 | 85 Pos/ 3 Neg |
| 625 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 750 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 875 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 1000 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
Semi-Quantitative Positive/Negative Results:
・
{5}------------------------------------------------
Performance Characteristics Summary: continued Hitachi 717 Analyzer
Precision: Qualitative, mA/min
| N=88 | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| (mA/min) | Mean | SD | % CV | Mean | SD | % CV |
| 0 ng/mL | 92.6 | 0.7 | 0.7% | 92.6 | 1.0 | 1.1% |
| 125 ng/mL | 122.1 | 0.7 | 0.6% | 122.1 | 1.0 | 0.8% |
| 250 ng/mL | 167.2 | 1.0 | 0.6% | 167.2 | 1.4 | 0.8% |
| 375 ng/mL | 210.0 | 1.1 | 0.5% | 210.0 | 1.6 | 0.8% |
| 500 ng/mL | 244.9 | 1.3 | 0.6% | 244.9 | 1.9 | 0.8% |
| 625 ng/mL | 273.5 | 1.5 | 0.6% | 273.5 | 2.2 | 0.8% |
| 750 ng/mL | 296.5 | 2.2 | 0.7% | 296.5 | 2.5 | 0.9% |
| 875 ng/mL | 318.1 | 1.8 | 0.6% | 318.1 | 2.4 | 0.7% |
| 1000 ng/mL | 336.5 | 2.1 | 0.6% | 336.5 | 3.0 | 0.9% |
Qualitative Positive/Negative Results:
| 500 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 |
| 125 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 250 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 375 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 500 ng/mL | 0% | 22 | 16 Pos/6 Neg | 88 | 62 Pos/26 Neg |
| 625 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 750 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 875 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 1000 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
Limit of Detection:
The lowest concentration that can be differentiated from the negative urine with 95% confidence is determined as 25 ng/mL.
Linearity:
Hitachi 717 Instrument: 0 - 2000 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 = 0.9791x -2.8289, r2=0.9996
Method Comparison - Clinical Samples:
From a total of ninety-five (95) clinical unaltered samples Semi-Quantitative Data: 97.87% agreement with positive,
100% agreement with negative samples
Qualitative Data:
97.87% agreement with positive,
100% agreement with negative samples
{6}------------------------------------------------
Performance Characteristics Summary: continued
Hitachi 717 Analyzer
Endogenous Compound Interference & Specificity & Cross-Reactivity:
No significant undesired cross reactants or endogenous substance interference was observed.
Summary:
The information provided in this pre-market notification demonstrates that the LZI Methamphetamine Enzyme Immunoassay at a cutoff value of 500 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/niass spectrometry (GC/MS or LC/MS), an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the LZI Methamphetanine Enzyme Innunoassay at a cutoff value of 500 ng/mL is safe and effective for its stated intended use.
{7}------------------------------------------------
Image /page/7/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
10903 New Hampshire Avenue Silver Spring, MD 20993
JAN 2 3 2012
Lin-Zhi International, Inc c/o Dr. Bernice Lin VP Operations 670 Almanor Avenue Sunnyvale, CA 94085
K113661 Re:
Trade Name: LZI Methamphetamine Enzyme Immunoassay Regulation Number: 21 CFR §862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: Class II Product Codes: LAF, DLJ, LAS Dated: December 12, 2011 Received: December 13, 2011
Dear Dr 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 (QS) regulation (21 CFR Part 820).
{8}------------------------------------------------
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro 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/Medical
Devices/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/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{9}------------------------------------------------
Premarket Notification
Indications for Use Statement
510(k) Number (if known):
LZI Methamphetamine Enzyme Immunoassay Device Name: LZI Methamphetamine Calibrators and Controls
Indications for Use:
The LZI Methamphetamine Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of d-methamphetamine in human urine, at the cutoff value of 500 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 and LCMS or (2) permitting laboratories to establish quality control procedures.
The LZI Methamphetamine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Methamphetamine Enzyme Immunoassay at a cutoff value of 500 ng/mL.
The LZI Methamphetamine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Methamphetamine Enzyme Immunoassay at a cutoff value of 500 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 V (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
And/Or
Chris
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K11366
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).