(36 days)
Not Found
No
The description details a homogeneous enzyme immunoassay based on competitive binding and spectrophotometric measurement. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or any other function of the device.
No
Explanation: This device is an in vitro diagnostic (IVD) test intended for qualitative and semi-quantitative analysis of benzodiazepines in human urine. It is used to detect substances in the body, not to treat or cure a disease or condition.
Yes
This device is intended for the "qualitative and semi-quantitative analyses of benzodiazepines in human urine," which provides preliminary analytical test results crucial for diagnostic processes, even if further confirmation is needed.
No
The device description clearly states it is a "ready-to-use, liquid reagent, homogeneous enzyme immunoassay" and describes a chemical process involving enzymes and spectrophotometry, indicating it is a chemical assay kit, not 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 analyses of benzodiazepines in human urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses specific antibodies to detect benzodiazepines in human urine. This is a common method for in vitro diagnostic testing.
- Anatomical Site: The test is performed on "human urine," which is a biological specimen.
- Intended User / Care Setting: It's designed for "professional use with a number of automated clinical chemistry analyzers," indicating it's used in a clinical or laboratory setting for diagnostic purposes.
- Performance Studies: The document describes performance studies evaluating characteristics like precision, sensitivity, accuracy, analytical recovery, and specificity, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (Syva EMIT® II Plus Benzodiazepine Assay) with a K number (K993985) strongly suggests this device is being submitted for regulatory clearance as an IVD, comparing its performance to an already cleared IVD.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Benzodiazepine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of benzodiazepines in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Benzodiazepine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order 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 the preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
JXM, DLJ, LAS
Device Description
LZI's Benzodiazepine Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect benzodiazepines in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between benzodiazepine labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
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
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 evaluated included precision, sensitivity, accuracy, analytical recovery, and specificity.
Key results from within run precision studies for qualitative analysis:
- LZI's Benzodiazepine EIA Negative: Mean (mA/min.) 361.0, SD 3.1, % CV 0.9
- LZI's Benzodiazepine EIA 100 ng/mL: Mean (mA/min.) 417.8, SD 3.5, % CV 0.8
- LZI's Benzodiazepine EIA 200 ng/mL: Mean (mA/min.) 455.5, SD 3.5, % CV 0.8
- LZI's Benzodiazepine EIA 300 ng/mL: Mean (mA/min.) 483.3, SD 3.5, % CV 0.7
- LZI's Benzodiazepine EIA 400 ng/mL: Mean (mA/min.) 504.9, SD 3.7, % CV 0.7
- LZI's Benzodiazepine EIA 1000 ng/mL: Mean (mA/min.) 559.7, SD 4.2, % CV 0.7
Key results from within run precision studies for semi-quantitative analysis:
- LZI's Benzodiazepine EIA 100 ng/mL: Mean (ng/mL) 105.7, SD 7.6, %CV 7.2
- LZI's Benzodiazepine EIA 200 ng/mL: Mean (ng/mL) 203.6, SD 5.9, %CV 2.9
- LZI's Benzodiazepine EIA 300 ng/mL: Mean (ng/mL) 281.8, SD 11.1, %CV 3.9
- LZI's Benzodiazepine EIA 400 ng/mL: Mean (ng/mL) 373.9, SD 15.3, %CV 4.1
Key results from run-to-run precision studies for qualitative analysis:
- LZI's Benzodiazepine EIA Negative: Mean (mA/min.) 360.0, SD 2.5, % CV 0.7
- LZI's Benzodiazepine EIA 100 ng/mL: Mean (mA/min.) 417.9, SD 2.5, % CV 0.6
- LZI's Benzodiazepine EIA 200 ng/mL: Mean (mA/min.) 457.0, SD 1.9, % CV 0.4
- LZI's Benzodiazepine EIA 300 ng/mL: Mean (mA/min.) 483.6, SD 2.5, % CV 0.5
- LZI's Benzodiazepine EIA 400 ng/mL: Mean (mA/min.) 504.4, SD 2.8, % CV 0.6
- LZI's Benzodiazepine EIA 1000 ng/mL: Mean (mA/min.) 561.8, SD 3.3, % CV 0.6
Key results from run-to-run precision studies for semi-quantitative analysis:
- LZI's Benzodiazepine EIA 100 ng/mL: Mean (ng/mL) 95.8, SD 6.4, %CV 6.7
- LZI's Benzodiazepine EIA 200 ng/mL: Mean (ng/mL) 192.0, SD 6.5, %CV 3.4
- LZI's Benzodiazepine EIA 300 ng/mL: Mean (ng/mL) 294.8, SD 15.5, %CV 5.3
- LZI's Benzodiazepine EIA 400 ng/ml: Mean (ng/mL) 398.6, SD 15.4, %CV 3.9
Accuracy Study:
- Vs. Syva (n=116)
- Positive Samples: 89.4 % agreement
- Negative Samples: 100 % agreement
Analytical Recovery:
- Semi-quantitative: Quantitates within ±10% of the nominal concentration between 20 ng/mL and 800 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 15 ng/mL (functional)
Accuracy: Positive Samples: 89.4 % agreement, Negative Samples: 100 % agreement
Specificity: Comparable to the predicate device.
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
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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
SEP - 5 2003
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:
| Contact: | Cheng-I Lin, Ph.D.
President, R&D Director |
| ---------- | ----------------------------------------------- |
|---|
Device Name and Classification
| Classification Name: | Benzodiazepine test system, Class II,
JMX (91 Toxicology),
21CFR 862.3170 |
|----------------------|---------------------------------------------------------------------------------------------|
| Common Name: | Homogeneous enzyme immunoassay for the determination of
Benzodiazepines levels in urine. |
| Proprietary Name: | None |
Legally Marketed Predicate Device(s)
Lin-Zhi International, Inc.' Benzodiazepine Enzyme Immunoassay is substantially equivalent to Syva EMIT® II Plus Benzodiazepine Assay (By Syva Company-Dade Behring Inc.), cleared under premarket notification K993985.
LZI's Benzodiazepine Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
LZI's Benzodiazepine Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect benzodiazepines in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
1
The assay is based on competition between benzodiazepine labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
Intended Use
The Benzodiazepine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of benzodiazepines in human urine.
Comparison to Predicate Device
LZI's Benzodiazepine Enzyme Immunoassay is substantially equivalent to other products in commercially distribution intended for similar use. Most notably it is substantially equivalent to the currently, commercially marketed Emit® II Plus Benzodiazepine Assay (K993985) by Syva Company-Dade Behring Inc.
The following table compares LZI's Benzodiazepine Enzyme Immunoassav with the predicate device, Emit® II Plus Benzodiazepine Assay by Syva Company-Dade Behring Inc.
Similarities:
- . Both assays are for qualitative and semi-quantitative determination of benzodiazepines in human urine.
- Both have dual cutoff design (200 ng/mL or 300 ng/mL). ●
- Both assays use 5 points calibration (0, 100, 200, 300, 1000 ng/ml) for semi-● quantitative determination.
- Both assays use the same method principle, and device components. ●
Difference:
- Syva's assay uses 150, 225, 250, 375 ng/mL for various control levels. LZI's . assay uses 100, 200, 300, 400 ng/mL for various control levels.
- . Syva's assay uses lormetazepam as calibrator and control. LZI's assay uses oxazepam as calibrator and control.
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| Performance Characteristics | ||||||||
|---|---|---|---|---|---|---|---|---|
| Feature | Syva's Benzodiazepine EIA | LZI's Benzodiazepine EIA | ||||||
| Within Run Precision: | ||||||||
| Qualitative: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 246.7 | 1.0 | 0.4 | Negative | 361.0 | 3.1 | 0.9 | |
| 150 ng/mL | 294.7 | 1.2 | 0.4 | 100 ng/mL | 417.8 | 3.5 | 0.8 | |
| 200 ng/mL | 310.5 | 1.4 | 0.5 | 200 ng/mL | 455.5 | 3.5 | 0.8 | |
| 225 ng/mL | 319.3 | 1.3 | 0.4 | 300 ng/mL | 483.3 | 3.5 | 0.7 | |
| 250 ng/mL | 325.5 | 1.4 | 0.4 | 400 ng/mL | 504.9 | 3.7 | 0.7 | |
| 300 ng/mL | 336.1 | 1.4 | 0.4 | 1000 ng/mL | 559.7 | 4.2 | 0.7 | |
| 375 ng/mL | 349.7 | 2.4 | 0.7 | |||||
| Semi-quantitative: | (ng/mL) | Mean | SD | %CV | (ng/mL) | Mean | SD | %CV |
| 150 ng/mL | 148.2 | 3.3 | 2.2 | 100 ng/mL | 105.7 | 7.6 | 7.2 | |
| 200 ng/mL | 196.7 | 10.2 | 5.2 | 200 ng/mL | 203.6 | 5.9 | 2.9 | |
| 225 ng/mL | 225.1 | 4.5 | 2.0 | 300 ng/mL | 281.8 | 11.1 | 3.9 | |
| 250 ng/mL | 247.3 | 5.3 | 2.1 | 400 ng/ml | 373.9 | 15.3 | 4.1 | |
| 300 ng/mL | 289.5 | 5.9 | 2.0 | |||||
| 375 ng/mL | 353.8 | 6.2 | 1.8 | |||||
| Run-To-Run Precision: | ||||||||
| Qualitative: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 246.7 | 1.7 | 0.7 | Negative | 360.0 | 2.5 | 0.7 | |
| 150 ng/mL | 294.7 | 2.1 | 0.7 | 100 ng/mL | 417.9 | 2.5 | 0.6 | |
| 200 ng/mL | 310.5 | 2.2 | 0.7 | 200 ng/mL | 457.0 | 1.9 | 0.4 | |
| 225 ng/mL | 319.3 | 2.4 | 0.8 | 300 ng/mL | 483.6 | 2.5 | 0.5 | |
| 250 ng/mL | 325.5 | 2.3 | 0.7 | 400 ng/mL | 504.4 | 2.8 | 0.6 | |
| 300 ng/mL | 336.1 | 2.4 | 0.7 | 1000 ng/mL | 561.8 | 3.3 | 0.6 | |
| 375 ng/mL | 349.7 | 3.6 | 1.0 | |||||
| Semi-quantitative: | (ng/mL) | Mean | SD | %CV | (ng/mL) | Mean | SD | %CV |
| 150 ng/mL | 148.2 | 4.2 | 2.8 | 100 ng/mL | 95.8 | 6.4 | 6.7 | |
| 200 ng/mL | 196.7 | 11.0 | 5.6 | 200 ng/mL | 192.0 | 6.5 | 3.4 | |
| 225 ng/mL | 225.1 | 5.7 | 2.5 | 300 ng/mL | 294.8 | 15.5 | 5.3 | |
| 250 ng/mL | 247.3 | 5.7 | 2.3 | 400 ng/ml | 398.6 | 15.4 | 3.9 | |
| 300 ng/mL | 289.5 | 7.4 | 2.6 | |||||
| 375 ng/mL | 353.8 | 11.0 | 3.1 | |||||
| Sensitivity: | 15 ng/mL | 15 ng/mL (functional) | ||||||
| Accuracy: | Vs. a commercial EIA | Vs. Syva (n=116) | ||||||
| Positive Samples: | 95.6 % agreement | 89.4 % agreement | ||||||
| Negative Samples: | 99% agreement | 100 % agreement | ||||||
| Analytical Recovery: | ||||||||
| Qualitative: 100 % accuracy on positive vs. | ||||||||
| negative tests | ||||||||
| Semi-quantitative: Quantitates within ±15% of the | Quantitates within ±10% of the | |||||||
| nominal concentration between 40 | nominal concentration between 20 | |||||||
| ng/mL and 900 ng/mL. | ng/mL and 800 ng/mL. | |||||||
| Specificity: | See attached Syva's Benzodiazepine | Comparable to the predicate device. | ||||||
| Assay package insert |
3
Conclusion
LZI's Benzodiazepine Enzyme Immunoassay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. All the studies showed acceptable results when compared to the predicate device.
We trust the information provided in this Premarket Notification [510(k)] submission will support a determination of substantial equivalence of the LZI's Benzodiazepine Enzyme Immunoassay to other Benzodiazepine test systems currently marketed in the United States.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is written around the top half of the circle. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP - 5 2003
Cheng-I Lin, Ph.D. President. R&D Director Lin-Zhi International, Inc. 687 North Pastroia Avenue Sunnyvale, CA 94085
Re: K032365
Trade/Device Name: Benzodiazepine Enzyme Immunoassay Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine Test System Regulatory Class: Class II Product Code: JXM, DLJ, LAS Dated: July 31, 2003 Received: July 31, 2003
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Premarket Notification
Indications for Use Statement
510(k) Number (if known): _
KO32368
Device Name: Benzodiazepine Enzyme Immunoassay
Indications for Use:
The Benzodiazepine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of benzodiazepines in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Benzodiazepine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order 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 the preliminary positive results are used.
Alberts
Division Sign-Off for Jean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032365
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
7
Premarket Notification Supplement
Indications for Use Statement
510(k) Number (if known):
Device Name: Benzodiazepine Drug of Abuse Calibrators and Controls
Indications for Use:
The Benzodiazepine Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Benzodiazepine enzyme immunoassay to detect benzodiazepines in human urine.
The Benzodiazepine Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Benzodiazepine enzyme immunoassay to detect benzodiazepines in human urine.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||||
|---|---|---|---|---|---|
| Prescription Use | |||||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |||
| (Optional Format 1-2-96) | |||||
| Office of In Vitro Diagnostic Device | |||||
| Evaluation and Safety |
510(k) K032365
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