(244 days)
Not Found
No
The device description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for analysis or interpretation.
No
This device is an immunoassay designed to detect the presence of d-amphetamine in oral fluid. It is an in vitro diagnostic tool used for qualitative and semi-quantitative determination, not for treating or preventing a disease or condition.
Yes
The device is intended for the qualitative and semi-quantitative determination of d-amphetamine in human oral fluid, which is a diagnostic purpose to identify the presence of a substance in a biological sample. Although it states it provides "only a preliminary analytical result," its function is clearly for initial diagnosis or screening.
No
The device description clearly outlines a kit comprised of physical reagents (R1 and R2 solutions), calibrators, controls, and a physical oral fluid collector tube. This indicates the device is a combination of hardware (collector tube) and chemical components (reagents, calibrators, controls), not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semi-quantitative determination of d-amphetamine in neat human oral fluid". This is a test performed in vitro (outside the body) on a human specimen (oral fluid) to provide information about a medical condition or state (presence of amphetamine).
- Device Description: The description details the components of the assay (reagents, calibrators, controls) which are used to perform the test in vitro.
- Performance Studies: The document includes performance characteristics and method comparison studies, which are typical for IVD devices to demonstrate their analytical performance.
- Regulatory Context: The mention of a "Predicate Device" with a K number (K063024) strongly indicates that this device is being submitted for regulatory clearance as an IVD. K numbers are associated with FDA 510(k) submissions for medical devices, including IVDs.
- Care Setting/User: It's intended for "prescription use with a number of automated clinical chemistry analyzers" and "Professional use," which aligns with the typical use of IVD assays in clinical laboratory settings.
Therefore, based on the provided information, the LZI Oral Fluid Amphetamine Enzyme Immunoassay is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LZI Oral Fluid Amphetamine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of d-amphetamine in neat human oral fluid, collected into the LZI Oral Fluid Collector, at the cutoff value 50 ng/mL. The assay is designed for prescription 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 Oral Fluid Amphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid Amphetamine Enzyme Immunoassay at the cutoff value 50 ng/mL.
The LZI Oral Fluid Amphetamine Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid Amphetamine Enzyme Immunoassay at the cutoff value of 50 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 liguid 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
DKZ, DLJ, LAS
Device Description
The LZI Oral Fluid Amphetamine 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, amphetamine-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 amphetamine-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 Oral Fluid Amphetamine Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The R solution contains mouse monoclonal anti-amphetamine 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 amphetamine in buffer with sodium azide (0.09%) as preservative.
The LZI Oral Fluid Amphetamine Enzyme Immunoassay calibrators and controls designated for use at the 50 ng/mL cutoffs contain 0, 25, 37.5, 50, 62.5, 100, and 140 ng/mL of d-amphetamine in human oral fluid with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
The LZI Oral Fluid Collector is a 50 mL polypropylene collection tube. It is a non-sterile centrifuge tube with a screw-on cap and printed graduations (United Lab Plastics, Catalog#UP2262).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics Summary: Hitachi 717 Analyzer
Semi-Quantitative Positive/Negative Results:
Sample Concentration: 0 ng/mL, % of Cutoff: -100.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Negative, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Negative
Sample Concentration: 12.5 ng/mL, % of Cutoff: -75.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Negative, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Negative
Sample Concentration: 25 ng/mL, % of Cutoff: -50.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Negative, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Negative
Sample Concentration: 37.5 ng/mL, % of Cutoff: -25.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Negative, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Negative
Sample Concentration: 50 ng/mL, % of Cutoff: 100.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 11 Pos/11 Neg, Number of Determination (total precision): 88, Immunoassay Result (total precision): 36 Pos/52 Neg
Sample Concentration: 62.5 ng/mL, % of Cutoff: +25.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Positive, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Positive
Sample Concentration: 75 ng/mL, % of Cutoff: +50.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Positive, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Positive
Sample Concentration: 87.5 ng/mL, % of Cutoff: +75.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Positive, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Positive
Sample Concentration: 100 ng/mL, % of Cutoff: +100.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Positive, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Positive
Qualitative Positive/Negative Results:
Sample Concentration: 0 ng/mL, % of Cutoff: -100.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Negative, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Negative
Sample Concentration: 12.5 ng/mL, % of Cutoff: -75.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Negative, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Negative
Sample Concentration: 25 ng/mL, % of Cutoff: -50.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Negative, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Negative
Sample Concentration: 37.5 ng/mL, % of Cutoff: -25.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Negative, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Negative
Sample Concentration: 50 ng/mL, % of Cutoff: 100.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 8 Pos/14 Neg, Number of Determination (total precision): 88, Immunoassay Result (total precision): 46 Pos/42 Neg
Sample Concentration: 62.5 ng/mL, % of Cutoff: +25.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Positive, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Positive
Sample Concentration: 75 ng/mL, % of Cutoff: +50.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Positive, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Positive
Sample Concentration: 87.5 ng/mL, % of Cutoff: +75.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Positive, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Positive
Sample Concentration: 100 ng/mL, % of Cutoff: +100.0%, Number of Determination (within run): 22, Immunoassay Result (within run): 22 Positive, Number of Determination (total precision): 88, Immunoassay Result (total precision): 88 Positive
Linearity:
Hitachi 717 Instrument: 0 - 140 ng/mL.
Regression equation: y = 1.0555x - 0.7832, r2 = 0.9945
Method Comparison: Clinical Samples
85 clinical unaltered samples.
For both Qualitative and Semi-Quantitative results: 100.0 % agreement with negative, 97.7 % agreement with positive samples.
Endogenous Compound Interference and Specificity - Cross-Reactivity:
No significant undesired cross reactants or endogenous substance interference was observed.
Shipping/Recovery Stability Study:
No significant sample degradation occurred following real-time and accelerated stability studies up to 72 hours.
Sample Storage Stability Study:
No significant sample degradation occurred following real-time and accelerated stability studies up to 13 Days. Samples can be stored at 2-8 ℃ for up to 13 Days. Accelerated stability data supports at least 18 months of shelf-life storage at -20 ℃.
Open (and re-capped) vial Stability for Calibrator/Control:
Real time (2 - 8 ℃) and accelerated stability studies (at room temperature and 30 ℃) were carried out for 17 months (568 Days) and results indicated degradation at all three conditions was minimal. Thermal stability data supports at least 18 months of shelf life storage at 2 - 8 ℃.
Closed Stability for Reagents Shelf-life:
Real-time stability studies were carried out for 17 months (568 Days) and results indicated degradation is minimal. Real-time stability data also supports at least 18 months of shelf life storage at 2 - 8 ℃.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
Kj31653
510(k) Summary of Safety and Effectiveness
FEB - 4 2014
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.
Preparation Date
January 30, 2014
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 Fax: (408) 732-3849 e-mail: bclin@lin-zhi.com
| Contact: | Bernice Lin, Ph.D. |
|---|---|
| VP Operations |
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Oral Fluid Amphetamine
Class II, DKZ (91 Toxicology),
21 CFR 862.3100 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Drug Specific Calibrators,
Class II, DLJ (91 Toxicology),
21 CFR 862.3200 |
| | Drug Specific Controls,
Class I, LAS (91 Toxicology),
21 CFR 862.3280 |
| Common Name:
Proprietary Name: | Homogeneous Oral Fluid Amphetamine Enzyme Immunoassay
LZI Oral Fluid Amphetamine Enzyme Immunoassay,
LZI Oral Fluid Amphetamine Calibrators
LZI Oral Fluid Amphetamine Controls |
1
Legally Marketed Predicate Device(s)
The LZI Oral Fluid Amphetamine Enzyme Immunoassay (K131653) is substantially equivalent to the Lin-Zhi International, Inc. Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (K063024) manufactured by Lin-Zhi International, Inc. The LZI Oral Fluid Amphetamine Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
The LZI Oral Fluid Amphetamine assay is a homogeneous enzyme immunoassay with ready-touse 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, amphetamine-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 amphetamine-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 Oral Fluid Amphetamine Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The R solution contains mouse monoclonal anti-amphetamine 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 amphetamine in buffer with sodium azide (0.09%) as preservative.
The LZI Oral Fluid Amphetamine Enzyme Immunoassay calibrators and controls designated for use at the 50 ng/mL cutoffs contain 0, 25, 37.5, 50, 62.5, 100, and 140 ng/mL of d-amphetamine in human oral fluid with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
The LZI Oral Fluid Collector is a 50 mL polypropylene collection tube. It is a non-sterile centrifuge tube with a screw-on cap and printed graduations (United Lab Plastics, Catalog#UP2262).
2
Intended Use
The LZI Oral Fluid Amphetamine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of d-amphetamine in neat human oral fluid, collected into the LZI Oral Fluid Collector, at the cutoff value 50 ng/mL. The assay is designed for prescription 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 Oral Fluid Amphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid Amphetamine Enzyme Immunoassay at the cutoff value 50 ng/mL.
The LZI Oral Fluid Amphetamine Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid Amphetamine Enzyme Immunoassay at the cutoff value of 50 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 liguid 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 LZI Oral Fluid Amphetamine Enzyme Immunoassay (K131653) is substantially equivalent to the Lin-Zhi International, Inc. Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems cleared by the FDA under the premarket notification K063024 for its stated intended use.
The following table compares LZI's Oral Fluid Amphetamine Enzyme Immunoassay (K131653) with the predicate device.
| Device | Subject Device (K131653) | Predicate Device (K063024) |
|---|---|---|
| LZI Oral Fluid Amphetamine Enzyme | LZI Oral Fluid Amphetamine Enzyme | |
| Characteristics | Immunoassay, Calibrators and Controls | Immunoassay, Calibrators and Controls |
| Intended Use | The LZI Oral Fluid Amphetamine | |
| Enzyme Immunoassay, is intended for the | ||
| qualitative and semi-quantitative | ||
| determination of d-amphetamine in neat | ||
| human oral fluid, collected into the LZI | ||
| Oral Fluid Collector, at the cutoff value | ||
| 50 ng/mL. The assay is designed for | ||
| prescription use with a number of | ||
| automated clinical chemistry analyzers. | ||
| This assay provides a rapid screening procedure | ||
| for determining the presence of d-amphetamine in | ||
| oral fluid. 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 Amphetamine-Specific Enzyme | |
| Immunoassays for Drugs of Abuse in Oral | ||
| Fluid is a homogeneous enzyme | ||
| immunoassay system to detect | ||
| amphetamine in human saliva with a | ||
| cutoff of 45 ng/mL when testing oral fluid | ||
| specimen collected with Salivette | ||
| collector (manufactured by Sarstedt) and | ||
| diluted with 1 mL of buffer. The | ||
| calibrators and controls of the analyte (d- | ||
| amphetamine) are prepared with oral fluid | ||
| buffer so that it can be used to verify and | ||
| validate the assay. The assay is intended | ||
| for use in the qualitative determination for | ||
| amphetamine. The assay is designed for | ||
| professional use with a number of | ||
| automated clinical chemistry analyzers. | ||
| The Oral Fluid Amphetamine-Specific Enzyme | ||
| Immunoassay is a homogeneous enzyme | ||
| immunoassay system 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. Clinical | ||
| consideration and professional judgment should be | ||
| applied to any drug-of-abuse test result, | ||
| particularly when preliminary positive results are | ||
| used. | ||
| Analyte | amphetamine | amphetamine |
| Cutoff | 50 ng/ml | 45 ng/mL |
| Matrix | Oral fluid | Oral fluid |
| Calibrator | 5 Levels | 5 Levels |
| Levels | (0, 25, 50, 100, 140 ng/mL) | (0, 15, 30, 45, 90 ng/mL) |
| Control Levels | 2 Levels | 2 Levels |
| (37.5 ng/mL, 62.5 ng/mL) | (30 ng/mL, 90 ng/mL) | |
| Storage | 2-8 ℃ until expiration date | 2-8 ℃ until expiration date |
4
Performance Characteristics Summary: Hitachi 717 Analyzer
| 50 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 |
| 12.5 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 25 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 37.5 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 50 ng/mL | 100.0% | 22 | 11 Pos/11 Neg | 88 | 36 Pos/52 Neg |
| 62.5 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 75 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 87.5 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 100 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
Semi-Quantitative Positive/Negative Results:
Qualitative Positive/Negative Results:
| 50 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 |
| 12.5 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 25 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 37.5 ng/mlL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 50 ng/mL | 100.0% | 22 | 8 Pos/14 Neg | 88 | 46 Pos/42 Neg |
| 62.5 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 75 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 87.5 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 100 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
Linearity:
Hitachi 717 Instrument: 0 - 140 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 = 1.0555x - 0.7832, r2 = 0.9945
Method Comparison: Clinical Samples
From a total of eighty-five (85) clinical unaltered samples For both Qualitative and Semi-Quantitative results: 100.0 % agreement with negative, 97.7 % agreement with positive samples
Endogenous Compound Interference and Specificity - Cross-Reactivity:
No significant undesired cross reactants or endogenous substance interference was observed. See product insert for list of compounds tested.
5
Shipping/Recovery Stability Study:
No significant sample degradation occurred following real-time and accelerated stability studies up to 72 hours. All sample shipments are based on the assumption of a 24 hour priority overnight delivery.
Sample Storage Stability Study:
No significant sample degradation occurred following real-time and accelerated stability studies up to 13 Days. Based on real-time studies, samples can be stored at 2-8 ℃ for up to 13 Days. Based on the Arrhenius equation, accelerated stability data supports at least 18 months of shelflife storage at -20 ℃. Real-time stability studies are on-going.
Open (and re-capped) vial Stability for Calibrator/Control:
Real time (2 - 8 ℃) and accelerated stability studies (at room temperature and 30 ℃) were carried out for 17 months (568 Days) and results indicated degradation at all three conditions was minimal. Thermal stability data supports at least 18 months of shelf life storage at 2 - 8 ℃.
Closed Stability for Reagents Shelf-life:
Real-time stability studies were carried out for 17 months (568 Days) and results indicated degradation is minimal. Real-time stability data also supports at least 18 months of shelf life storage at 2 - 8 ℃.
Summary:
The information provided in this pre-market notification demonstrates that the LZI Oral Fluid Amphetamine Enzyme Immunoassay (K131653) 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 gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS), an independent analytical method, The information supplied in this pre-market notification provides reasonable assurance that the LZI Oral Fluid Amphetamine Enzyme Immunoassay is safe and effective for its stated intended use.
200 - 100 - 100 .. Det 11: 11:3 : :
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2014
LIN-ZHI INTERNATIONAL, INC. BERNICE LIN VP OPERATIONS 670 ALMANOR AVENUE SUNNYVALE CA 94085
Re: K131653
Trade/Device Name: LZI Oral Fluid Amphetamine Enzyme Immunoassay LZI Oral Fluid Amphetamine Calibrators and Controls Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DLJ, LAS Dated: December 10, 2013 Received: December 12, 2013
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. Isting 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 2014.02.02
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
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131653
Device Name
LZ! Oral Fluid Amphetamine Enzyme Immunoassay and LZI Oral Fluid Amphetamine Calibrators and Controls
Indications for Use (Describe)
The LZI Oral Fluid Amphetamine Enzyme Immunossay is intended for the qualitative determination of damphetamine in neat human oral fluid, collected into the LZI Oral Fluid Collector, at the cutoff value of 50 ng/mL. The assay is designed for prescription 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 LZI Oral Fluid Amphetamine Calibrators are for use as callorators in the qualitative callbration of the LZI Oral Fluid Amphetamine Enzyme Immunoassay at the cutoff value of 50 ng/mL.
The LZI Oral Fluid Amphetamine Controls are for use as assayed quality control materials to monitor the LZI Oral Fluid Amphetamine Enzyme Immunoassay at the cutoff value of 50 ng/mL.
The assay provides only a preliminary analytical result. A more specific altemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GCMS) is the preferred confimatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, paticularly when the preliminary test result is positive.
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
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