(125 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
The device is an in vitro diagnostic (IVD) test intended for the qualitative and semi-quantitative determination of a buprenorphine metabolite in human urine. It is used to monitor drug levels and provides a preliminary analytical result, which is then confirmed by other methods. It does not provide any therapeutic benefit or treatment.
Yes
The device is intended for the "qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine," which is a form of diagnostic testing to detect the presence and amount of a specific substance in a biological sample. It provides a "preliminary analytical result" used for clinical consideration.
No
The device description clearly outlines a homogeneous enzyme immunoassay with ready-to-use liquid reagents and relies on spectrophotometric measurement at 340 nm, indicating a chemical and hardware-based assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine". This involves testing a sample taken from the human body in vitro (outside the body) to provide information about a physiological state (presence of a drug metabolite).
- Device Description: The description details a "homogeneous enzyme immunoassay" which is a common type of laboratory test performed on biological samples.
- Intended User / Care Setting: The intended users are "professional use in clinics and clinical chemistry laboratories", which are typical settings for performing IVD tests.
- Performance Studies: The document describes performance studies conducted on "human urine" and "clinical unaltered samples", further indicating the testing of human biological specimens.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K081008) strongly suggests that this device is being submitted for regulatory clearance as a medical device, specifically an IVD, by comparing it to a previously cleared device of the same type.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DLJ, LAS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
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: Semi-Quantitative, ng/mL
N=88, N=88. The table shows within-run and total precision for various concentrations (ng/mL), including Negative, 2.5 ng/mL, 5.0 ng/mL, 7.5 ng/mL, 10 ng/mL, 12.5 ng/mL, 15 ng/mL, 17.5 ng/mL, and 20 ng/mL. It provides mean, SD, and %CV for each concentration.
Semi-Quantitative Positive/Negative Results:
For 5 ng/mL Cutoff Result (N=22 within run, N=88 total precision):
- 0 ng/mL: 22 Negative (within run), 88 Negative (total precision)
- 2.5 ng/mL: 22 Negative (within run), 88 Negative (total precision)
- 5.0 ng/mL: 15 POS/7 NEG (within run), 62 POS/26 NEG (total precision)
- 7.5 ng/mL: 22 Positive (within run), 88 Positive (total precision)
- 10.0 ng/mL: 22 Positive (within run), 88 Positive (total precision)
For 10 ng/mL Cutoff Result (N=22 within run, N=88 total precision):
- 0 ng/mL to 7.5 ng/mL: All Negative (within run and total precision)
- 10.0 ng/mL: 15 POS/7 NEG (within run), 47 POS/41 NEG (total precision)
- 12.5 ng/mL to 20.0 ng/mL: All Positive (within run and total precision)
Precision: Qualitative, mA/min
N=88. The table shows within-run and total precision for various concentrations (mA/min) including Negative, 2.5 ng/mL, 5.0 ng/mL, 7.5 ng/mL, 10 ng/mL, 12.5 ng/mL, 15 ng/mL, 17.5 ng/mL, and 20 ng/mL. It provides mean, SD, and %CV for each concentration.
Qualitative Positive/Negative Results:
For 5 ng/mL Cutoff Result (N=22 within run, N=88 total precision):
- 0 ng/mL: 22 Negative (within run), 88 Negative (total precision)
- 2.5 ng/mL: 22 Negative (within run), 88 Negative (total precision)
- 5.0 ng/mL: 9 POS/13 NEG (within run), 43 POS/45 NEG (total precision)
- 7.5 ng/mL: 22 Positive (within run), 88 Positive (total precision)
- 10.0 ng/mL: 22 Positive (within run), 88 Positive (total precision)
For 10 ng/mL Cutoff Result (N=22 within run, N=88 total precision):
- 0 ng/mL to 7.5 ng/mL: All Negative (within run and total precision)
- 10.0 ng/mL: 18 POS/4 NEG (within run), 59 POS/29 NEG (total precision)
- 12.5 ng/mL to 20.0 ng/mL: All Positive (within run and total precision)
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
Regression equation: y=1.0026x + 0.9053, r2=0.991
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for precision, positive/negative agreement, detection limit, linearity, and agreement with GC/MS. Specific sensitivity/specificity metrics not explicitly broken out.
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
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
1
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.
2
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.
| Device
Characteristics | Subject Device
LZI Buprenorphine Enzyme
Immunoassay | Predicate Device (K081008)
LZI Buprenorphine Enzyme
Immunoassay
for Beckman Coulter® Synchron Systems |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
This assay provides a rapid screening procedure
for determining the presence of norbuprenorphine
(buprenorphine metabolite) 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. Chromatography/mass spectrometry
(GC/MS or LC/MS) is the preferred confirmatory
method. Clinical consideration and professional
judgement should be exercised with any drug of
abuse test result, particularly when the preliminary
test result is positive. | The Lin-Zhi International (LZI)
Buprenorphine Enzyme Immunoassay,
when used in conjunction with Beckman
Coulter® Synchron LX®, CX®, and
UniCel® DxC automated clinical system
analyzers, is intended for the qualitative
and semi-quantitative determination of
norbuprenorphine (buprenorphine
metabolite) in human urine, at a cutoff
value of 10 ng/mL.
This assay provides a rapid screening procedure
for determining the presence of norbuprenorphine
(buprenorphine metabolite) 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. Chromatography/mass spectrometry
(GC/MS or LC/MS) is the preferred confirmatory
method. Clinical consideration and professional
judgement should be exercised with any drug of
abuse test result, particularly when the preliminary
test result is positive. |
| Analyte | Norbuprenorphine (buprenorphine
metabolite) | Norbuprenorphine (buprenorphine
metabolite) |
| Cutoff | 5 and 10 ng/ml | 10 ng/ml |
| Matrix | Urine | Urine |
| Calibrators
Level | 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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・
:
:
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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 | |||
|---|---|---|---|---|---|
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 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 |
《《《《
4
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 | |||
|---|---|---|---|---|---|
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 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 | ||||
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 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
5
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.
ાં ર
6
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).
7
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
8
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)