(289 days)
Not Found
No
The device description and performance studies detail a standard enzyme immunoassay method and do not mention any AI or ML components.
No.
This device is an in vitro diagnostic (IVD) test for the qualitative and semi-quantitative determination of d-methamphetamine in human oral fluid. It is used for diagnostic purposes and not for treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the qualitative and semi-quantitative determination of d-methamphetamine in neat human oral fluid," which is a diagnostic purpose.
No
The device is a kit containing chemical reagents (R1 and R2 solutions), calibrators, controls, and a physical oral fluid collector. It is an enzyme immunoassay, which is a laboratory test method involving chemical reactions, 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-methamphetamine in neat human oral fluid". This is a diagnostic test performed on a biological sample (oral fluid) to detect the presence and approximate amount of a substance (methamphetamine).
- Sample Type: It uses "human oral fluid", which is a biological specimen.
- Method: It employs an "Enzyme Immunoassay", which is a common in vitro diagnostic technique.
- Purpose: The purpose is to provide a "preliminary analytical result" for the presence of methamphetamine, which is a diagnostic step in identifying drug use.
- Components: The device includes reagents, calibrators, and controls, which are typical components of an IVD kit used for testing biological samples.
- Care Setting/User: It is intended for "prescription use with a number of automated clinical chemistry analyzers" and used by professionals, indicating it's for use in a clinical laboratory setting.
All these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The LZI Oral Fluid Methamphetamine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of d-methamphetamine 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 Methamphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid Methamphetamine Enzyme Immunoassay at the cutoff value 50 ng/mL.
The LZI Oral Fluid Methamphetamine Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid Methamphetamine 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 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 (comma separated list FDA assigned to the subject device)
LAF, DLJ, LAS
Device Description
The LZI Oral Fluid Methamphetamine 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, 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 Oral Fluid 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-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-o-phosphate dehydrogenase (G6PDH) labeled with methamphetamine in buffer with sodium azide (0.09%) as preservative.
The LZI Oral Fluid Methamphetamine Enzyme Immunoassay calibrators and controls designated for use at the 50 ng/mL cutoffs contain 0, 20, 37.5, 50, 62.5, 100, and 140 ng/mL of dmethamphetamine 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
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, Within Run Number of Determination, Immunoassay Result: 0 ng/mL, 22, 22 Negative; 12.5 ng/mL, 22, 22 Negative; 25 ng/mL, 22, 22 Negative; 37.5 ng/mL, 22, 22 Negative; 62.5 ng/mL, 22, 22 Positive; 75 ng/mL, 22, 22 Positive; 87.5 ng/mL, 22, 22 Positive; 100 ng/mL, 22, 22 Positive.
Total Precision Number of Determination, Immunoassay Result: 0 ng/mL, 88, 88 Negative; 12.5 ng/mL, 88, 88 Negative; 25 ng/mL, 88, 88 Negative; 37.5 ng/mL, 88, 88 Negative; 62.5 ng/mL, 88, 88 Positive; 75 ng/mL, 88, 88 Positive; 87.5 ng/mL, 88, 88 Positive; 100 ng/mL, 88, 88 Positive.
Qualitative Positive/Negative Results:
Sample Concentration, Within Run Number of Determination, Immunoassay Result: 0 ng/mL, 22, 22 Negative; 12.5 ng/mL, 22, 22 Negative; 25 ng/mL, 22, 22 Negative; 37.5 ng/mL, 22, 22 Negative; 62.5 ng/mL, 22, 22 Positive; 75 ng/mL, 22, 22 Positive; 87.5 ng/mL, 22, 22 Positive; 100 ng/mL, 22, 22 Positive.
Total Precision Number of Determination, Immunoassay Result: 0 ng/mL, 88, 88 Negative; 12.5 ng/mL, 88, 88 Negative; 25 ng/mL, 88, 88 Negative; 37.5 ng/mL, 88, 88 Negative; 62.5 ng/mL, 88, 88 Positive; 75 ng/mL, 88, 88 Positive; 87.5 ng/mL, 88, 88 Positive; 100 ng/mL, 88, 88 Positive.
Linearity:
Hitachi 717 Instrument: 5 - 140 ng/mL
Regression equation and correlation: y = 0.9834x -0.9874, r2 = 0.9993
Method Comparison: Clinical Samples
Total of eighty-five (85) clinical unaltered samples.
For both Qualitative and Semi-Quantitative results: 100.0 % agreement with positive, 95.2 % agreement with negative 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.
Based on real-time studies, samples can be stored at 2-8 ℃ for up to 15 Days.
Based on the Arrhenius equation, accelerated stability data supports at least 18 months of shelflife 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 (508 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 ℃.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR 2 1 2014
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.
Preparation Date
March 19, 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
Bernice Lin, Ph.D. Contact: VP Operations
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Oral Fluid Methamphetamine
Class II, LAF (91 Toxicology),
21 CFR 862.3610
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: | Homogeneous Oral Fluid Methamphetamine Enzyme
Immunoassay |
| Proprietary Name: | LZI Oral Fluid Methamphetamine Enzyme Immunoassay,
LZI Oral Fluid Methamphetamine Calibrators
LZI Oral Fluid Methamphetamine Controls |
1
Legally Marketed Predicate Device(s)
The LZI Oral Fluid Methamphetamine Enzyme Immunoassay (K131652) is substantially equivalent to the Lin-Zhi International, Inc. Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (K062242) manufactured by Lin-Zhi International, Inc. The LZI Oral Fluid Methamphetamine 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 Methamphetamine 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, 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 Oral Fluid 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-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-o-phosphate dehydrogenase (G6PDH) labeled with methamphetamine in buffer with sodium azide (0.09%) as preservative.
The LZI Oral Fluid Methamphetamine Enzyme Immunoassay calibrators and controls designated for use at the 50 ng/mL cutoffs contain 0, 20, 37.5, 50, 62.5, 100, and 140 ng/mL of dmethamphetamine 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 Methamphetamine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of d-methamphetamine 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 Methamphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid Methamphetamine Enzyme Immunoassay at the cutoff value 50 ng/mL.
The LZI Oral Fluid Methamphetamine Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid Methamphetamine 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 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.
3
Comparison to Predicate Device
The LZI Oral Fluid Methamphetamine Enzyme Immunoassay (K131652) is substantially equivalent to the Lin-Zhi International, Inc. Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems cleared by the FDA under the premarket notification K062242 for its stated intended use.
The following table compares LZI's Oral Fluid Methamphetamine Enzyme Immunoassay (K131652) with the predicate device.
| Device
Characteristics | Subject Device (K131652)
LZI Oral Fluid Methamphetamine
Enzyme Immunoassay, Calibrators and
Controls | Predicate Device (K062242)
LZI Oral Fluid Methamphetamine
Enzyme Immunoassay, Calibrators and
Controls |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LZI Oral Fluid Methamphetamine
Enzyme Immunoassay, is intended for the
qualitative and semi-quantitative
determination of d-methamphetamine 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 Methamphetamine Enzyme
Immunoassays for Drugs of Abuse in Oral
Fluid is a homogeneous enzyme
immunoassay system to detect
methamphetamine 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-
methamphetamine) 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 methamphetamine. 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 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 Oral Fluid Methamphetamine 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 | d-methamphetamine | d-methamphetamine |
| Cutoff | 50 ng/mL | 45 ng/mL |
| Matrix | Oral fluid | Oral fluid |
| Calibrator
Levels | 5 Levels
(0, 20, 50, 100, 140 ng/mL) | 5 Levels
(0, 15, 30, 45, 90 ng/mL) |
| Control Levels | 2 Levels
(37.5 ng/mL, 62.5 ng/mL) | 2 Levels
(15 ng/mL, 45 ng/mL) |
| Storage | 2-8 ℃ until expiration date | 2-8 ℃ until expiration date |
4
Performance Characteristics Summary:
Hitachi 717 Analyzer
| Sample
| Concentration | Within Run | Total Precision | ||
|---|---|---|---|---|
| Number of | ||||
| Determination | Immunoassay | |||
| Result | Number of | |||
| Determination | Immunoassay | |||
| Result | ||||
| 0 ng/mL | 22 | 22 Negative | 88 | 88 Negative |
| 12.5 ng/mL | 22 | 22 Negative | 88 | 88 Negative |
| 25 ng/mL | 22 | 22 Negative | 88 | 88 Negative |
| 37.5 ng/mL | 22 | 22 Negative | 88 | 88 Negative |
| 62.5 ng/mL | 22 | 22 Positive | 88 | 88 Positive |
| 75 ng/mL | 22 | 22 Positive | 88 | 88 Positive |
| 87.5 ng/mL | 22 | 22 Positive | 88 | 88 Positive |
| 100 ng/mL | 22 | 22 Positive | 88 | 88 Positive |
Semi-Quantitative Positive/Negative Results:
Qualitative Positive/Negative Results:
| Sample
| Concentration | Within Run | Total Precision | ||
|---|---|---|---|---|
| Number of | ||||
| Determination | Immunoassay | |||
| Result | Number of | |||
| Determination | Immunoassay | |||
| Result | ||||
| 0 ng/mL | 22 | 22 Negative | 88 | 88 Negative |
| 12.5 ng/mL | 22 | 22 Negative | 88 | 88 Negative |
| 25 ng/mL | 22 | 22 Negative | 88 | 88 Negative |
| 37.5 ng/mL | 22 | 22 Negative | 88 | 88 Negative |
| 62.5 ng/mL | 22 | 22 Positive | 88 | 88 Positive |
| 75 ng/mL | 22 | 22 Positive | 88 | 88 Positive |
| 87.5 ng/mL | 22 | 22 Positive | 88 | 88 Positive |
| 100 ng/mL | 22 | 22 Positive | 88 | 88 Positive |
Linearity:
Hitachi 717 Instrument: 5 - 140 ng/mL
When using drug-free samples spiked with known amounts of d-methamphetamine and comparing the result (y) and target (x) value, using the least squares regression technique, the regression equation and correlation are as follow:
y = 0.9834x -0.9874, r2 = 0.9993
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 positive, 95.2 % agreement with negative 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 15 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 (508 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 ℃.
Summary:
The information provided in this pre-market notification demonstrates that the LZI Oral Fluid Methamphetamine Enzyme Immunoassay (K131652) 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 Methamphetamine Enzyme Immunoassay is substantially equivalent to the predicate device in terms of safety and effectiveness for its stated intended use.
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 stylized eagle-like symbol with three trailing lines, positioned to the right of a circular emblem. The circular emblem contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2014
LIN-ZHI INTERNATIONAL, INC. BERNICE LIN VP OF OPERATIONS 670 ALMANOR AVE SUNNYVALE CA 94085
Re: K131652
Trade/Device Name: LZI Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, LZI Oral Fluid Methamphetamine Calibrators LZI Oral Fluid Methamphetamine Controls
Regulation Number: 21 CFR 862.3600 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: LAF, DLJ, LAS Dated: December 18, 2013 Received: December 23, 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting 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
7
Page 2-Dr. Lin
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of 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/Reportal?roblem/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 vours.
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K131652
Device Name
LZI Oral Fluid Methamphetamine Enzyme Immunossay LZI Oral Fluid Methamphetamine Calibrators LZI Oral Fluid Methamphami
Indications for Use (Describe)
The LZI Oral Fluid Methamphetamine Enzyme Immunoassay is intended for the qualitative determination of dmethamphetanine 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 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 or LC/MS) is the preferred confimatory 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 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 Methamphetamine Calibrators are for use as calibrators in the qualitative calibration of the LZI Oral Fluid Methamphetamine Enzyme Immunoassay at the cutoff value of 50 ng/mL.
The LZI Oral Fluid Methamphetamine Controls are for use as assayed quality control materials to monitor the LZI Oral Fluid Methamphetamine Enzyme Immunoassay at the cutoff value of 50 ng/mL.
Type of Use (Select one or both, as applicable) | Over-The-Counter Use (21 CFR 801 Subpart C) [x] Prescription Use (Part 21 CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR USE ONLY IN THE PHOTO CHANNER FE 的一个人 - 家居梅德 -
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)