(56 days)
Not Found
No
The device description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is an in vitro diagnostic (IVD) test intended for the qualitative and semiquantitative determination of morphine in human urine. It is used for analytical purposes to provide a preliminary result, not for direct treatment or diagnosis of a disease.
Yes
Explanation: The device is intended for the qualitative and semiquantitative determination of morphine in human urine, providing preliminary analytical results which are typical of diagnostic tests.
No
The device description clearly outlines a homogeneous enzyme immunoassay kit comprised of liquid reagents (R1 and R2 solutions) and calibrators/controls. This is a chemical assay, not a software-only device. While it is used with automated clinical chemistry analyzers (which contain software), the device itself is the chemical kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "qualitative and semiquantitative determination of morphine in human urine". This involves testing a sample taken from the human body (in vitro) to provide diagnostic information (determining the presence and approximate amount of a substance).
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses "ready-to-use liquid reagents" to analyze a sample. This is a typical description of an in vitro diagnostic test.
- Sample Type: The assay is performed on "human urine".
- Professional Use: The device is intended for "professional use with a number of automated clinical chemistry analyzers," which are commonly used in clinical laboratories for diagnostic testing.
- Calibrators and Controls: The inclusion of calibrators and controls is standard practice for IVD assays to ensure accuracy and quality control.
- Preliminary Analytical Result: While the assay provides a preliminary result and recommends confirmation, this is common for screening IVD tests, particularly for drugs of abuse. The initial test is still a diagnostic step.
- Predicate Devices: The mention of predicate devices with K numbers (K020638 & K020769) further indicates that this device is being compared to other legally marketed IVD devices.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LZI Opiate 2000 Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of morphine in human urine at a cutoff value of 2000 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 Opiate 2000 Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 ng/mL.
The LZI Opiate 2000 Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 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)
DJG, DLJ, LAS
Device Description
The LZI Opiate 2000 assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. 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, morphine-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 morphinelabeled 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 Opiate 2000 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-morphine antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with morphine in buffer with sodium azide (0.09%) as preservative.
The LZI Opiate 2000 Enzyme Immunoassay calibrators and controls designated for use at the 2000 ng/mL cutoff contain 0, 1000, 1500, 2000, 2500, 4000, and 6000 ng/mL of morphine 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Study (Hitachi 717 Analyzer):
- Semi-Quantitative Precision: N=88, various morphine concentrations (0 to 4000 ng/mL). Showed varying SD and %CV, indicating good precision.
- Qualitative Precision: N=88, various morphine concentrations (0 to 4000 ng/mL). Showed low SD and %CV for qualitative (mA/min) readings.
- Semi-Quantitative Positive/Negative Results: Evaluated positive/negative calls at different concentrations relative to the 2000 ng/mL cutoff. At 2000 ng/mL cutoff, out of 88 total determinations, 59 were Positive and 29 were Negative. Below the cutoff (0-1500 ng/mL), all results were Negative. Above the cutoff (2500-4000 ng/mL), all results were Positive.
- Qualitative Positive/Negative Results: Evaluated positive/negative calls at different concentrations relative to the 2000 ng/mL cutoff. At 2000 ng/mL cutoff, out of 88 total determinations, 33 were Positive and 55 were Negative. Below the cutoff (0-1500 ng/mL), all results were Negative. Above the cutoff (2500-4000 ng/mL), all results were Positive.
Limit of Detection:
- The lowest concentration that can be differentiated from the negative urine with 95% confidence is determined as 200 ng/mL.
Linearity:
- Hitachi 717 Instrument: 0 - 6000 ng/mL
- Regression equation: y = 1.078x - 85.072, r2 = 0.993
Method Comparison - Clinical Samples:
- Sample size: 150 clinical unaltered samples.
- Semi-Quantitative Data: 96.49% agreement with positive, 93.55% agreement with negative samples.
- Qualitative Data: 96.49% agreement with positive, 96.77% agreement with negative samples.
Endogenous Compound Interference & Specificity & Cross-Reactivity:
- No significant undesired cross-reactants or endogenous substance interference was observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement with positive samples for semi-quantitative data: 96.49%
Agreement with negative samples for semi-quantitative data: 93.55%
Agreement with positive samples for qualitative data: 96.49%
Agreement with negative samples for qualitative data: 96.77%
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
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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
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:
Enzyme Immunoassay, Opiate Class II, DJG (91 Toxicology), 21 CFR 862.3650
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 Opiate 2000 Enzyme Immunoassay LZI Opiate 2000 Enzyme Immunoassay, LZI Opiate 2000 Drugs of Abuse (DAU) Calibrators LZI Opiate 2000 Drugs of Abuse (DAU) Controls
1
Legally Marketed Predicate Device(s)
The LZI Opiate 2000 Enzyme Immunoassay (EIA) at a cutoff of 2000 ng/mL is substantially equivalent to the LZI Opiate Enzyme Immunoassay and Opiate Calibrators and Controls (K020638 & K020769) manufactured by Lin-Zhi International, Inc with a cutoff of 300 ng/mL. The LZI Opiate 2000 Enzyme Immunoassav is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
The LZI Opiate 2000 assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. 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, morphine-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 morphinelabeled 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 Opiate 2000 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-morphine antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with morphine in buffer with sodium azide (0.09%) as preservative.
The LZI Opiate 2000 Enzyme Immunoassay calibrators and controls designated for use at the 2000 ng/mL cutoff contain 0, 1000, 1500, 2000, 2500, 4000, and 6000 ng/mL of morphine 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 Opiate 2000 Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of morphine in human urine at a cutoff value of 2000 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 Opiate 2000 Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 ng/mL.
The LZI Opiate 2000 Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 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 Lin-Zhi International, Inc. LZI Opiate 2000 Enzyme Immunoassay used at the 2000 ng/mL cutoff is substantially equivalent to the Lin-Zhi International, Inc. Opiate Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems cleared by the FDA under the premarket notification K020638 & K020769 for its stated intended use.
The following table compares LZI's Opiate 2000 Enzyme Immunoassay at the 2000 ng/mL cutoff with the predicate device.
| Device
Characteristics | Subject Device
LZI Opiate 2000 Enzyme Immunoassay,
Calibrators and Controls | Predicate Device
(K020638 & K020769)
LZI Opiate Enzyme Immunoassay,
Calibrators and Controls |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LZI Opiate 2000 Enzyme
Immunoassay, when used in conjunction
with Hitachi 717 automated clinical
system analyzers, is intended for the
qualitative and semi-quantitative
determination of morphine in human
urine at a cutoff value of 2000 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 morphine 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 Opiate 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 morphine in human
urine at a cutoff value of 300 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 morphinein 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 | morphine | morphine |
| Cutoff | 2000 ng/ml | 300 ng/mL |
| Matrix | Urine | Urine |
| Calibrators
Level | 5 Levels
(0, 1000, 2000, 4000, 6000 ng/mL) | 5 Levels
(0, 150, 300, 600, 1000 ng/mL) |
| Controls Level | 2 Levels
(1500 ng/mL, 2500 ng/mL) | 2 Levels
(225 ng/mL, 375 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 | 64.9 | 21.37 | 36.6% | 64.9 | 25.7 | 39.6% |
| 500 ng/mL | 448.9 | 18.11 | 4.1% | 448.9 | 22.1 | 4.9% |
| 1000 ng/mL | 1014.4 | 24.22 | 2.4% | 1014.4 | 24.8 | 2.4% |
| 1500 ng/mL | 1559.8 | 20.07 | 1.3% | 1559.8 | 22.6 | 1.4% |
| 2000 ng/mL | 2018.4 | 32.22 | 1.6% | 2018.4 | 37.6 | 1.9% |
| 2500 ng/mL | 2492.3 | 46.4 | 1.9% | 2492.3 | 47.0 | 1.9% |
| 3000 ng/mL | 3065.5 | 87.91 | 2.9% | 3065.5 | 90.1 | 2.9% |
| 3500 ng/mL | 3620.0 | 64.06 | 1.8% | 3620.0 | 71.4 | 2.0% |
| 4000 ng/mL | 4013.2 | 83.96 | 2.1% | 4013.2 | 96.9 | 2.4% |
Semi-Quantitative Precision Analysis Summary: Qualitative Results
| N=88
| (ng/mL) | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Mean | Qualitative Response | Mean | Qualitative Response | ||
| 0 ng/mL | 64.9 | - | 64.9 | - | |
| 500 ng/mL | 448.9 | - | 448.9 | - | |
| 1000 ng/mL | 1014.4 | - | 1014.4 | - | |
| 1500 ng/mL | 1559.8 | - | 1559.8 | - | |
| 2000 ng/mL | 2018.4 | + | 2018.4 | + | |
| 2500 ng/mL | 2492.3 | + | 2492.3 | + | |
| 3000 ng/mL | 3065.5 | + | 3065.5 | + | |
| 3500 ng/mL | 3620.0 | + | 3620.0 | + | |
| 4000 ng/mL | 4013.2 | + | 4013.2 | + |
Semi-Quantitative Positive/Negative Results:
| 2000 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 |
| 500 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 1000 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 1500 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 2000 ng/mL | 0% | 22 | 18 Pos/ 4 Neg | 88 | 59 Pos/ 29 Neg |
| 2500 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 3000 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 3500 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 4000 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
5
Performance Characteristics Summary: (continued) Hitachi 717 Analyzer
Precision: Qualitative, mA/min
| N=88
| (mA/min) | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| Mean | SD | % CV | Mean | SD | % CV | |
| 0 ng/mL | 229.2 | 1.67 | 0.7% | 229.2 | 1.9 | 0.8% |
| 500 ng/mL | 271.2 | 1.74 | 0.6% | 271.2 | 2.2 | 0.8% |
| 1000 ng/mL | 335.9 | 1.48 | 0.4% | 335.9 | 2.7 | 0.8% |
| 1500 ng/mL | 384.7 | 1.68 | 0.4% | 384.7 | 2.8 | 0.7% |
| 2000 ng/mL | 414.5 | 2.70 | 0.7% | 414.5 | 3.5 | 0.9% |
| 2500 ng/mL | 441.9 | 1.9 | 0.4% | 441.9 | 3.1 | 0.7% |
| 3000 ng/mL | 461.9 | 3.36 | 0.7% | 461.9 | 4.2 | 0.9% |
| 3500 ng/mL | 478.6 | 2.97 | 0.6% | 478.6 | 3.5 | 0.7% |
| 4000 ng/mL | 489.4 | 2.24 | 0.5% | 489.4 | 2.9 | 0.6% |
Qualitative Positive/Negative Results:
| 2000 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 |
| 500 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 1000 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 1500 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 2000 ng/mL | 0% | 22 | 9 Pos/ 13 Neg | 88 | 33 Pos/ 55 Neg |
| 2500 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 3000 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 3500 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 4000 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 200 ng/mL.
Linearity:
Hitachi 717 Instrument: 0 - 6000 ng/mL
When comparing the result (y) and target (x) value, using the least squares regression technique, the regression equation and correlation are as follows: y = 1.078x - 85.072, r2 = 0.993
Method Comparison - Clinical Samples:
From a total of one-hundred fifty (150) clinical unaltered samples
Semi-Quantitative Data:
96.49% agreement with positive,
93.55% agreement with negative samples
Qualitative Data:
96.49% agreement with positive,
96.77% 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 Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 ng/mL is substantially equivalent to the legally marketed predicate device for its general intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by chromatography/mass spectrometry (GC/MS or LC/MS), an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the LZI Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 ng/mL is safe and effective for its stated intended use.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Lin-Zhi International, Inc. c/o Bernice Lin, Ph.D. Vice President, Operations 670 Almanor Ave Sunnyvale, CA 94085
MAY - 8 2012
K120761 Re:
Ite: - - R120701 LZI Opiate 2000 Enzyme Controls
Regulation Number: 21CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, DLJ and LAS Dated: April 26, 2012 Received: April 27, 2012
Dear Dr. Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nove and have 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 provision in the Federal with the provisions of the Federal Food, Drug, and Cosmetic nave och toe 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 therefore, market the de nee, acreed requirements for annual registration, listing of devices, good controls provisions of the engans and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be finay oc subject to Back as 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 that FDA has made a dolorinination administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (2) CFR Part with an the Ace 3 requirements, moral 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manisang your dever of your device to a legally prematication: "The PDF Imaning sistems for your device and thus, permits your device to proceed to the market.
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/Resourcesfor You/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):
Device Name: LZI Opiate 2000 Enzyme Immunoassay LZI Opiate 2000 Calibrators and Controls
Indications for Use:
The LZI Opiate 2000 Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of morphine in human urine at the cutoff value of 2000 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 Opiate 2000 Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 ng/mL.
The LZI Opiate 2000 Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 ng/mL.
The assay provides only a preliminary analytical result: A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Prescription Use AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) (Per 21 CFR 801.109)
Division Sign-Off
Office of In Vitro Diagnostic Olice Evaluation and Safety
510(k) K120761
Page 9 of 77