(41 days)
Not Found
No
The device description and performance studies focus on a standard enzyme immunoassay method and do not mention any AI or ML components.
No.
The device is an in vitro diagnostic (IVD) tool designed for detecting d-methamphetamine in human urine. It provides analytical results and is not intended for the treatment or cure of any disease or condition.
Yes
The device is an immunoassay intended for the qualitative and semiquantitative determination of a substance (d-methamphetamine) in human urine, which serves as a preliminary analytical result for drug testing. This falls under the definition of a diagnostic device as it provides information for health purposes, specifically related to the presence of a controlled substance.
No
The device is a kit containing liquid reagents for a chemical assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative and semiquantitative determination of d-methamphetamine in human urine". This is a diagnostic test performed on a biological sample (urine) in vitro (outside the body).
- Device Description: The description details a "homogeneous enzyme immunoassay" which is a common type of in vitro diagnostic test. It describes the reagents and how they interact with the sample to produce a measurable result.
- Professional Use: The intended user is described as "professional use with a number of automated clinical chemistry analyzers," which are instruments typically used in clinical laboratories for in vitro diagnostic testing.
- Calibrators and Controls: The inclusion of calibrators and controls is standard practice for in vitro diagnostic assays to ensure accuracy and quality control.
- Performance Studies: The document includes performance studies such as precision, limit of detection, linearity, and method comparison using clinical samples, which are all characteristic of the validation required for in vitro diagnostic devices.
- Predicate Device: The mention of a predicate device (K102210; Amphetamines 500 Enzyme Immunoassay and Amphetamine 500 Calibrators and Controls for Hitachi 717 Systems) further confirms its classification as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
All these elements strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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 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.
Product codes
LAF, DLJ, LAS
Device Description
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-o-phosphate dehydrogenase (GoPDH) 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The assay is designed for professional use with a number of automated clinical chemistry analyzers.
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
The performance studies include precision analyses in both semi-quantitative and qualitative modes, limit of detection, linearity, and method comparison with clinical samples.
Precision (Semi-Quantitative, ng/mL):
N=88 for each concentration.
Results are presented for different concentrations (0, 125, 250, 375, 500, 625, 750, 875, 1000 ng/mL) showing Mean, SD, and %CV for Within Run and Total Precision. For example, at 500 ng/mL, Mean = 513.5, Within Run SD = 6.05 (%CV = 1.2%), Total Precision SD = 8.3 (%CV = 1.6%).
Semi-Quantitative Precision Analysis Summary (Qualitative Results):
Analyzed based on 500 ng/mL cutoff.
For 0, 125, 250, 375 ng/mL samples, all 22 (Within Run) and 88 (Total Precision) determinations were Negative.
For 500 ng/mL, 22 determinations (Within Run) were 22 Positive. For Total Precision (88 determinations), 85 Positive / 3 Negative.
For 625, 750, 875, 1000 ng/mL samples, all 22 (Within Run) and 88 (Total Precision) determinations were Positive.
Precision (Qualitative, mA/min):
N=88 for each concentration.
Results are presented for different concentrations (0, 125, 250, 375, 500, 625, 750, 875, 1000 ng/mL) showing Mean, SD, and %CV for Within Run and Total Precision. For example, at 500 ng/mL, Mean = 244.9, Within Run SD = 1.3 (%CV = 0.6%), Total Precision SD = 1.9 (%CV = 0.8%).
Qualitative Positive/Negative Results:
Analyzed based on 500 ng/mL cutoff.
For 0, 125, 250, 375 ng/mL samples, all 22 (Within Run) and 88 (Total Precision) determinations were Negative.
For 500 ng/mL, 22 determinations (Within Run) were 16 Pos/6 Neg. For Total Precision (88 determinations), 62 Pos/26 Neg.
For 625, 750, 875, 1000 ng/mL samples, all 22 (Within Run) and 88 (Total Precision) determinations were 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:
For Hitachi 717 Instrument, range 0 - 2000 ng/mL.
Regression equation: y = 0.9791x -2.8289, r2=0.9996.
Method Comparison - Clinical Samples:
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.
Interference & Specificity & Cross-Reactivity:
No significant undesired cross reactants or endogenous substance interference was observed.
Key Metrics
Precision (Semi-Quantitative, ng/mL):
At 500 ng/mL:
Mean: 513.5
Within Run SD: 6.05, %CV: 1.2%
Total Precision SD: 8.3, %CV: 1.6%
Semi-Quantitative Precision Analysis Summary (Qualitative Results):
At 500 ng/mL cutoff:
Within Run (22 determinations): 22 Positive
Total Precision (88 determinations): 85 Positive / 3 Negative
Precision (Qualitative, mA/min):
At 500 ng/mL:
Mean: 244.9
Within Run SD: 1.3, %CV: 0.6%
Total Precision SD: 1.9, %CV: 0.8%
Qualitative Positive/Negative Results:
At 500 ng/mL cutoff:
Within Run (22 determinations): 16 Pos/6 Neg
Total Precision (88 determinations): 62 Pos/26 Neg
Limit of Detection: 25 ng/mL (at 95% confidence)
Linearity (r2): 0.9996
Method Comparison - Clinical 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.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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.
| Device
| Characteristics | Subject Device | Predicate Device (K102210) |
|---|---|---|
| LZI Methamphetamine Enzyme | ||
| Immunoassay | Amphetamines 500 Enzyme | |
| Immunoassay, Calibrators and Controls | ||
| Intended Use | The LZI Methamphetamine Enzyme | |
| Immunoassay, when used in conjunction | ||
| with Hitachi 717 automated clinical | ||
| system analyzers, is intended for the | ||
| qualitative and semi-quantitative | ||
| determination of 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. |
This assay provides a rapid screening procedure
for determining the presence of d-
methamphetamine in urine. 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 Amphetamines 500 Enzyme
Immunoassay from Lin-Zhi International,
Inc., when used in conjunction with
Hitachi 717 automated clinical system
analyzers is intended for the qualitative
and semi-quantitative determination of
amphetamine and 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.
This assay provides a rapid screening procedure
for determining the presence of d-
methamphetamine and d-amphetamine in urine.
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. |
| Analyte | d-methamphetamine | d-methamphetamine &
d-amphetamine |
| Cutoff | 500 ng/ml | 500 ng/mL |
| Matrix | Urine | Urine |
| Calibrators
Level | 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 Run
Qualitative Response | Mean | Total Precision
Qualitative 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 | |||
|---|---|---|---|---|---|
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 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 | |||
|---|---|---|---|---|---|
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 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