(125 days)
The Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine, at a cutoff value of 5 and 10 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Norbuprenorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay.
The Norbuprenorphine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Lin-Zhi International (LZI) Buorenorphine Enzyme Immunoassay.
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. Chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
The LZI Buprenorphine 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, buprenorphine-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 buorenorphine-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
Here's an analysis of the acceptance criteria and study as presented in the provided document:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the study. Instead, it presents performance characteristics (Precision, Semi-Quantitative/Qualitative Positive/Negative Results, Detection Limit, Linearity, and Method Comparison) which are presumably used to demonstrate substantial equivalence to the predicate device. For the purpose of this response, I will interpret the performance goals shown in the predicate device's characteristics (implicitly matching or improving upon them) and the presented "agreement" percentages with the GC/MS method as the de-facto acceptance criteria.
| Acceptance Criteria | Reported Device Performance (LZI Buprenorphine Enzyme Immunoassay) |
|---|---|
| Precision (Semi-Quantitative, ng/mL): | Achieved |
| Range of %CV for various concentrations (0.5 to 20 ng/mL) within run and total precision. (No explicit target values are given, but the device reports detailed %CV values). | Within Run %CV: 3.0 - 116.1% Total Precision %CV: 3.7 - 121.4% (Note: The high %CV for "Negative" samples (0.5 ng/mL mean) is expected due to very low concentration near the detection limit.) |
| Precision (Qualitative, mA/min): | Achieved |
| Range of %CV for various concentrations (0 to 20 ng/mL) within run and total precision. (No explicit target values are given, but the device reports detailed %CV values). | Within Run %CV: 0.6 - 0.8% Total Precision %CV: 0.8 - 1.3% |
| Semi-Quantitative Positive/Negative Results (5 ng/mL Cutoff): | Achieved |
| Ability to correctly classify samples at concentrations below, at, and above the cutoff with a certain number of determinations. (No explicit percentage agreement target, but implies high accuracy). | -100% (0 ng/mL): 88/88 Negative (100%) -50% (2.5 ng/mL): 88/88 Negative (100%) 100% (5.0 ng/mL): 62/88 Positive, 26/88 Negative (70.5% Positive) - This indicates the cutoff itself is where ambiguity is expected. +50% (7.5 ng/mL): 88/88 Positive (100%) +100% (10.0 ng/mL): 88/88 Positive (100%) |
| Semi-Quantitative Positive/Negative Results (10 ng/mL Cutoff): | Achieved |
| Ability to correctly classify samples at concentrations below, at, and above the cutoff with a certain number of determinations. | -100% (0 ng/mL): 88/88 Negative (100%) -75% (2.5 ng/mL): 88/88 Negative (100%) -50% (5.0 ng/mL): 88/88 Negative (100%) -25% (7.5 ng/mL): 88/88 Negative (100%) 100% (10.0 ng/mL): 47/88 Positive, 41/88 Negative (53.4% Positive) - Again, ambiguity at the cutoff. +25% (12.5 ng/mL): 88/88 Positive (100%) +50% (15.0 ng/mL): 88/88 Positive (100%) +75% (17.5 ng/mL): 88/88 Positive (100%) +100% (20.0 ng/mL): 88/88 Positive (100%) |
| Qualitative Positive/Negative Results (5 ng/mL Cutoff): | Achieved |
| Ability to correctly classify samples at concentrations below, at, and above the cutoff with a certain number of determinations for qualitative assessment. | -100% (0 ng/mL): 88/88 Negative (100%) -50% (2.5 ng/mL): 88/88 Negative (100%) 100% (5.0 ng/mL): 43/88 Positive, 45/88 Negative (48.9% Positive) +50% (7.5 ng/mL): 88/88 Positive (100%) +100% (10.0 ng/mL): 88/88 Positive (100%) |
| Qualitative Positive/Negative Results (10 ng/mL Cutoff): | Achieved |
| Ability to correctly classify samples at concentrations below, at, and above the cutoff with a certain number of determinations for qualitative assessment. | -100% (0 ng/mL): 88/88 Negative (100%) -75% (2.5 ng/mL): 88/88 Negative (100%) -50% (5.0 ng/mL): 88/88 Negative (100%) -25% (7.5 ng/mL): 88/88 Negative (100%) 100% (10.0 ng/mL): 59/88 Positive, 29/88 Negative (67.0% Positive) +25% (12.5 ng/mL): 88/88 Positive (100%) +50% (15.0 ng/mL): 88/88 Positive (100%) +75% (17.5 ng/mL): 88/88 Positive (100%) +100% (20.0 ng/mL): 88/88 Positive (100%) |
| Detection Limit: | Achieved |
| Differentiable from negative urine with 95% confidence. | 2 ng/mL |
| Linearity (Regression equation and correlation): | Achieved |
| Good correlation between device and target values over a range. | y=1.0026x + 0.9053, r²=0.991 (over 2-70 ng/mL) |
| Method Comparison (5 ng/mL Cutoff): | Achieved |
| High agreement with GC/MS for positive and negative samples. (Implied target is high agreement). | 96.4% agreement with positive samples 100.0% agreement with negative samples |
| Method Comparison (10 ng/mL Cutoff): | Achieved |
| High agreement with GC/MS for positive and negative samples. | 95.1% agreement with positive samples 98.0% agreement with negative samples |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Precision Studies (Semi-Quantitative and Qualitative): N=88. These samples were tested across 4 runs (22 determinations per run to reach 88 total determinations) to assess "Total Precision" and "Within Run" precision. The description implies these are spiked samples (e.g., "0 ng/mL", "2.5 ng/mL", etc.).
- Sample Size for Method Comparison against GC/MS: 90 clinical unaltered samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The samples for the method comparison are described as "clinical unaltered samples," suggesting they were collected from patients, which would typically be retrospective or prospective clinical samples. The precision samples appear to be laboratory-prepared or spiked samples.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The ground truth for the method comparison study was established through a "more specific alternative chemical method," specifically Chromatography/mass spectrometry (GC/MS or LC/MS).
- Qualifications of Experts: Not applicable, as GC/MS is an analytical instrument-based method rather than expert interpretation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by an objective analytical method (GC/MS) rather than human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic assay for measuring substance concentration, not an imaging or diagnostic device that involves human interpretation of results requiring AI assistance.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Yes, the entire study focuses on the standalone performance of the LZI Buprenorphine Enzyme Immunoassay. It's an automated assay, and its performance is evaluated directly against laboratory controls and a gold standard analytical method (GC/MS), without human interpretation as part of its primary function. The results (e.g., precision, detection limit, linearity, agreement with GC/MS) represent the algorithm (assay chemistry and analyzer's measurement) only.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the method comparison study was established using Chromatography/mass spectrometry (GC/MS). This is considered a highly specific and sensitive "confirmatory method" for drug analysis, often regarded as the gold standard in toxicology. For precision and linearity, laboratory-prepared samples with known concentrations served as the ground truth.
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not explicitly mention a "training set" in the context of machine learning or AI development. This device is a chemical immunoassay, not a machine learning algorithm that requires a separate training set. The various calibration and control levels mentioned (e.g., 6 Calibrator Levels, 3 Control Levels) are used for calibrating the assay itself and monitoring its performance, which is analogous to "training" in a broad sense for traditional assays, but not in the machine learning context.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: As stated above, there isn't a traditional "training set" as understood in a machine learning context. For the assay's calibration (which ensures accurate measurement), the calibrators (e.g., 0, 5, 10, 20, 40, 75 ng/mL Norbuprenorphine Drugs of Abuse (DAU) Calibrators) are used. These would contain specified, known concentrations of norbuprenorphine, which serve as their own "ground truth" for calibration. These concentrations are typically verified by highly accurate analytical methods during their manufacture.
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JUL 30 2009
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. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 (408) 732-3849 Fax: Email: mtlin@lin-zhi.com
Contact:
Marie Lin, Ph.D. President
Device Name and Classification
Classification Name:
Enzyme immunoassay, Opiates Class II, DJG (91 Toxicology), 21 CFR 862.3650
Norbuprenorphine calibrators, Class II, DLJ (91 Toxicology), 21 CFR 862.3200
Norbuprenorphine controls, Class I, LAS (91 Toxicology), 21 CFR 862.3280
Common Name: Proprietary Name:
Homogeneous Buprenorphine Enzyme Immunoassay LZI Buprenorphine Enzyme Immunoassay, Norbuprenorphine Drugs of Abuse (DAU) Calibrators Norbuprenorphine Drugs of Abuse (DAU) Controls
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Legally Marketed Predicate Device(s)
The LZI Buprenorphine Enzyme Immunoassay (EIA) is substantially equivalent to the LZI Burrenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems (K081008) manufactured by Lin-Zhi International, Inc. LZI's Buprenorphine 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 Buprenorphine 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, buprenorphine-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 buorenorphine-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
Intended Use.
The Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine. at a cutoff value of 5 and 10 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Norbuprenorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay.
The Norbuprenorphine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Lin-Zhi International (LZI) Buorenorphine Enzyme Immunoassay.
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. 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.
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Comparison to Predicate Device
The LZI Buprenorphine Enzyme Immunoassay is substantially equivalent to the LZI Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems, cleared by the FDA under the premarket notification K081008 for its stated intended use.
The following table compares LZI's Buprenorphine Enzyme Immunoassay with the predicate device.
| DeviceCharacteristics | Subject DeviceLZI Buprenorphine EnzymeImmunoassay | Predicate Device (K081008)LZI Buprenorphine EnzymeImmunoassayfor Beckman Coulter® Synchron Systems |
|---|---|---|
| Intended Use | The Lin-Zhi International (LZI)Buprenorphine Enzyme Immunoassay isintended for the qualitative and semi-quantitative determination ofnorbuprenorphine (buprenorphinemetabolite) in human urine, at a cutoffvalue of 5 and 10 ng/mL. The assay isdesigned for professional use with anumber of automated clinical chemistryanalyzers.This assay provides a rapid screening procedurefor determining the presence of norbuprenorphine(buprenorphine metabolite) in urine. The assayprovides only a preliminary analytical result. Amore specific alternative chemical method must beused in order to obtain a confirmed analyticalresult. Chromatography/mass spectrometry(GC/MS or LC/MS) is the preferred confirmatorymethod. Clinical consideration and professionaljudgement should be exercised with any drug ofabuse test result, particularly when the preliminarytest result is positive. | The Lin-Zhi International (LZI)Buprenorphine Enzyme Immunoassay,when used in conjunction with BeckmanCoulter® Synchron LX®, CX®, andUniCel® DxC automated clinical systemanalyzers, is intended for the qualitativeand semi-quantitative determination ofnorbuprenorphine (buprenorphinemetabolite) in human urine, at a cutoffvalue of 10 ng/mL.This assay provides a rapid screening procedurefor determining the presence of norbuprenorphine(buprenorphine metabolite) in urine. The assayprovides only a preliminary analytical result. Amore specific alternative chemical method must beused in order to obtain a confirmed analyticalresult. Chromatography/mass spectrometry(GC/MS or LC/MS) is the preferred confirmatorymethod. Clinical consideration and professionaljudgement should be exercised with any drug ofabuse test result, particularly when the preliminarytest result is positive. |
| Analyte | Norbuprenorphine (buprenorphinemetabolite) | Norbuprenorphine (buprenorphinemetabolite) |
| Cutoff | 5 and 10 ng/ml | 10 ng/ml |
| Matrix | Urine | Urine |
| CalibratorsLevel | 6 Levels(0, 5, 10, 20, 40, 75 ng/mL) | 6 Levels(0, 5, 10, 20, 40, 100 ng/mL) |
| Controls Level | 3 Levels(3 ng/mL, 7 ng/mL, 13 ng/mL) | 2 Levels(7 ng/mL, 13 ng/mL) |
| Storage | 2-8°C until expiration date | 2-8°C until expiration date |
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Performance Characteristics Summary: Hitachi 717 Analyzer: .
| N=88 | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| (ng/mL) | Mean | SD | % CV | Mean | SD | % CV |
| Negative | 0.5 | 0.6 | 116.1 | 0.5 | 0.6 | 121.4 |
| 2.5 ng/mL | 3.0 | 0.3 | 9.5 | 3.0 | 0.4 | 14.4 |
| 5.0 ng/mL | 5.2 | 0.3 | 6.5 | 5.2 | 0.5 | 9.4 |
| 7.5 ng/mL | 7.7 | 0.3 | 4.3 | 7.7 | 0.5 | 6.0 |
| 10 ng/mL | 10.0 | 0.4 | 4.0 | 10.0 | 0.5 | 5.3 |
| 12.5 ng/mL | 12.1 | 0.4 | 3.4 | 12.1 | 0.5 | 4.4 |
| 15 ng/mL | 14.5 | 0.6 | 4.4 | 14.5 | 0.8 | 5.5 |
| 17.5 ng/mL | 17.0 | 0.5 | 3.0 | 17.0 | 0.6 | 3.7 |
| 20 ng/mL | 19.9 | 0.7 | 3.4 | 19.9 | 0.8 | 4.0 |
Precision: Semi-Quantitative, ng/mL
Semi-Quantitative Positive/Negative Results:
| 5 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| SampleConcentration | % of Cutoff | Number ofDetermination | ImmunoassayResult | Number ofDetermination | ImmunoassayResult |
| 0.ng/mL | -100 % | 22 | 22 Negative | 88 | 88 Negative |
| 2.5 ng/mL | -50 % | 22 | 22 Negative | 88 | 88 Negative |
| 5.0 ng/mL | 100 % | 22 | 15 POS/7 NEG | 88 | 62 POS/26 NEG |
| 7.5 ng/mL | +50 % | 22 | 22 Positive | 88 | 88 Positive |
| 10:0 ng/mL | +100 % | 22 | 22 Positive | 88 | 88 Positive |
| 10 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | % of Cutoff | Number of Determination | Immunoassay Result | Number of Determination | Immunoassay Result |
| Concentration | |||||
| 0 ng/mL | -100 % | 22 | 22 Negative | 88 | 88 Negative |
| 2.5 ng/mL | -75 % | 22 | 22 Negative | 88 | 88 Negative |
| 5.0 ng/mL | -50 % | 22 | 22 Negative | 88 | 88 Negative |
| 7.5 ng/mL | -25 % | 22 | 22 Negative | 88 | 88 Negative |
| 10.0 ng/mL | 100 % | 22 | 15 POS/7 NEG | 88 | 47 POS/41 NEG |
| 12:5 ng/mL | +25 % | 22 | 22 Positive | 88 | 88 Positive |
| 15.0 ng/mL | +50 % | 22 | 22 Positive | 88 | 88 Positive |
| 17:5 ng/mL | +75 % | 22 | 22 Positive | 88 | 88 Positive |
| 20.0 ng/mL | +100 % | 22 | 22 Positive | 88 | 88 Positive |
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Lin-Zhi International, Inc.
| N=88 | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| (mAmin) | Mean | SD | % CV | Mean | SD | % CV |
| Negative | 400.9 | 3.2 | 0.8 | 400.9 | 5.1 | 1.3 |
| 2.5 ng/mL | 419.6 | 2.7 | 0.6 | 419.6 | 4.0 | 0.9 |
| 5.0 ng/mL | 439.2 | 3.2 | 0.7 | 439.2 | 5.0 | 1.1 |
| 7.5 ng/mL | 461.2 | 3.3 | 0.7 | 461.2 | 4.7 | 1.0 |
| 10 ng/mL | 479.2 | 3.2 | 0.7 | 479.2 | 4.5 | 0.9 |
| 12.5 ng/mL | 495.4 | 3.3 | 0.7 | 495.4 | 4.8 | 1.0 |
| 15 ng/mL | 511.7 | 3.3 | 0.6 | 511.7 | 4.6 | 0.9 |
| 17.5 ng/mL | 526.8 | 3.2 | 0.6 | 526.8 | 4.5 | 0.9 |
| 20 ng/mL | 540.3 | 3.5 | 0.6 | 540.3 | 4.5 | 0.8 |
Precision: Qualitatiye, mA/min
Qualitative Positive/Negative Results:
| 5 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| SampleConcentration | % of Cutoff | Number ofDetermination | ImmunoassayResult | Number ofDetermination | ImmunoassayResult |
| 0 ng/mL | -100 % | 22 | 22 Negative | 88 | 88 Negative |
| 2.5 ng/mL | -50 % | 22 | 22 Negative | 88 | 88 Negative |
| 5.0 ng/mL | 100 % | 22 | 9 POS/13 NEG | 88 | 43 POS/45 NEG |
| 7.5 ng/mL | +50 % | 22 | 22 Positive | 88 | 88 Positive |
| 10.0 ng/mL | +100 % | 22 | 22 Positive | 88 | 88 Positive |
| 10 ng/mL Cutoff Result: | |||||
|---|---|---|---|---|---|
| Within Run | Total Precision | ||||
| SampleConcentration | % of Cutoff | Number ofDetermination | ImmunoassayResult | Number ofDetermination | ImmunoassayResult |
| 0 ng/mL | -100 % | 22 | 22 Negative | 88 | 88 Negative |
| 2.5 ng/mL | -75 % | 22 | 22 Negative | 88 | 88 Negative |
| 5.0 ng/mL | -50 % | 22 | 22 Negative | 88 | 88 Negative |
| 7.5 ng/mL | -25 % | 22 | 22 Negative | 88 | 88 Negative |
| 10.0 ng/mL | 100 % | 22 | 18 POS/4 NEG | 88 | 59 POS/29 NEG |
| 12.5 ng/mL | +25 % | 22 | 22 Positive | 88 | 88 Positive |
| 15.0 ng/mL | +50 % | 22 | 22 Positive | 88 | 88 Positive |
| 17.5 ng/mL | +75 % | 22 | 22 Positive | 88 | 88 Positive |
| 20.0 ng/mL | +100 % | 22 | 22 Positive | 88 | 88 Positive |
Detection Limit:
The lowest concentration that can be differentiated from the negative urine with 95%, confidence is determined as 2 ng/miL.
Linearity:
.
Hitachi 717 Instrument: 2-70 ng/mL
3
When comparing the result (y) and target (x) value, using the least squares regression technique, the regression equation and correlation are as follow: y=1.0026x + 0.9053, r2=0.991
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Lin-Zhi International, Inc.
Method comparison against GC/MS confirmation device:
90 clinical unaltered samples:
5 ng/mL Cutoff
(96.4 % agreement with positive, 100.0 % agreement with negative samples)
10 ng/mL Cutoff
(95.1 % agreement with positive, 98.0 % agreement with negative samples)
Specificity and Endogenous Substances:
No significant undesired cross reactants or endogenous substance interference were observed. See product insert for list of compounds tested.
Summary:
The information provided in this pre-market notification demonstrates that the LZI Buprenorphine Enzyme Immunoassay is substantially equivalent to the legally marketed predicated 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 chromatography/mass spectrometry, an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the LZI Buprenorphine Enzyme Immunoassay is safe and effective for its stated intended use.
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of a human figure with three arms or lines extending upwards, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Lin-Zhi International, Inc. c/o Dr. Marie Lin President 687 North Pastoria Avenue Sunnyvale, CA 94085
Jul 3 0 2009
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Re: K090844
Trade Name: Buprenorphine Enzyme Immunoassay, Opiates, Norbuprenorphine Drug of Abuse Calibrators, Norbuprenorphine Drugs of Abuse Controls
Regulation Number: 21 CFR $862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Codes: DJG, DLJ, LAS Dated: June 18, 2009 Received: June 19, 2009
Dear Dr. Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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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/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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Premarket Notification Indications for Use Statement
510(k) Number (if known): K090844
Device Name: Buprenorphine Enzyme Immunoassav Norbuprenorphine Calibrators and Controls
Indications For Use:
The Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine, at a cutoff value of 5 and 10 ng/mL. The assay is designed for prescription use in clinics and clinical chemistry laboratories with a number of automated clinical chemistry analyzers.
The Norbuprenorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay.
The Norbuprenorphine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay.
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. 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 (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) (Per 21 CFR 801.109)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safe
510(k)
§ 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).