(156 days)
No
The device description and performance studies focus on a standard enzyme immunoassay technology, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic (IVD) assay used for qualitative screening of human urine samples for the presence of certain drugs, which aids in diagnosis and treatment, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section states: "Measurements obtained by this device are used in the diagnosis and treatment of in divisiouals who have used barbiturates, methadone, benzodiazepines, and propoxyphene drug."
No
The device is a homogeneous enzyme immunoassay, which is a chemical reagent-based test, not a software-only device. It is designed for use with automated clinical chemistry analyzers, which are hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is for the "qualitative screening human urine samples for the presence of barbiturates, methadone. benzodiazepines, and propoxyphene drugs." It also mentions that "Measurements obtained by this device are used in the diagnosis and treatment of in divisiouals who have used barbiturates, methadone, benzodiazepines, and propoxyphene druation". This clearly indicates that the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes.
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses "specific antibodies" to detect drugs in "human urine". This describes a laboratory test performed outside of the body on a biological sample.
- Anatomical Site: The specified anatomical site is "human urine", which is a biological specimen.
- Intended User / Care Setting: The device is designed for "professional use with a number of automated clinical chemistry arralyzes," indicating use in a clinical laboratory setting.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay. The assay is solely intended for use in the qualitative screening human urine samples for the presence of barbiturates, methadone. benzodiazepines, and propoxyphene drugs. . The assay will produce a positive result if any of the four analyte are present at a concentration at or above their respective cutoffs but will not its its is is is is drug is present. The assay is solely intended for the qualitative screening of human writer for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of in divisiouals who have used barbiturates, methadone, benzodiazepines, and propoxyphene druation on mourvis designed for professional use with a number of automated clinical chemistry arralyzes.
The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. The assay will not identify which drug is present in the positive urine sample. All screening positive samples shall subject to minist assays to identify the drug in the sample before alternative confirmation. Gas chromations withings spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, when preliminary positive results are used.
Product codes
DIS, DJR, JXM, JXN
Device Description
LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect barbiturates, methadone, benzodiazepines, and propoxyphene drugs in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between drug 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 enzymc 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 convert 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.
- Precision (Within Run, n=21; Run-To-Run, n=12):
- LZI's BMBP EIA (Barbiturate): Covered negative, 100 ng/mL, 200 ng/mL, 300 ng/mL, 1000 ng/mL. % CV generally below 1%.
- LZI's Barbiturate EIA (Predicate): Covered negative, 100 ng/mL, 200 ng/mL, 300 ng/mL, 1000 ng/mL. % CV generally below 1%.
- LZI's BMBP EIA (Methadone): Covered negative, 225 ng/mL, 300 ng/mL, 375 ng/mL, 1000 ng/mL. % CV generally below 1%.
- LZI's Methadone EIA (Predicate): Covered negative, 225 ng/mL, 300 ng/mL, 375 ng/mL, 1000 ng/mL. % CV generally below 1%.
- LZI's BMBP EIA (Benzodiazepine): Covered negative, 100 ng/mL, 200 ng/mL, 300 ng/mL, 1000 ng/mL. % CV generally below 1%.
- LZI's Benzodiazepine EIA (Predicate): Covered negative, 100 ng/mL, 200 ng/mL, 300 ng/mL, 1000 ng/mL. % CV generally below 1%.
- LZI's BMBP EIA (Propoxyphene): Covered negative, 225 ng/mL, 300 ng/mL, 375 ng/mL, 1000 ng/mL. % CV generally below 1%.
- LZI's Propoxyphene EIA (Predicate): Covered negative, 225 ng/mL, 300 ng/mL, 375 ng/mL, 1000 ng/mL. % CV generally below 1%.
- Accuracy:
- Barbiturate:
- Vs. LZI Barbiturate EIA: Positive Samples: 100 % agreement, Negative Samples: 92.5 % agreement.
- Vs. a commercial EIA (Predicate): 91.1 % agreement (positive), 100 % agreement (negative).
- Methadone:
- Vs. LZI Methadone EIA: Positive Samples: 100 % agreement, Negative Samples: 95.0 % agreement.
- Vs. a commercial EIA (Predicate): 100 % agreement (positive), 100 % agreement (negative). (100% vs. GC/MS /HPLC for positive).
- Benzodiazepine:
- Vs. LZI Benzodiazepine EIA: Positive Samples: 100 % agreement, Negative Samples: 97.5 % agreement. (96.9 % agreement(vs. GC/MS /HPLC) for positive)
- Vs. a commercial EIA (Predicate): 84 % agreement (negative).
- Propoxyphene:
- Vs. LZI Propoxyphene EIA: Positive Samples: 100 % agreement, Negative Samples: 97.5 % agreement.
- Vs. a commercial EIA (Predicate): 100 % agreement (positive), 100 % agreement (negative). (100 % agreement(vs. GC/MS /HPLC) for positive).
- Barbiturate:
- Analytical Recovery:
- 100 % accuracy on positive vs. negative tests for all analytes for both subject device and predicate devices.
- Specificity:
- "See attached Assay package insert" for subject device.
- "Comparable to the predicate device" for predicate devices.
All studies showed acceptable results when compared to the individual predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sensitivity:
- Barbiturate: 50 ng/mL for LZI's BMBP EIA, 25 ng/mL for LZI's Barbiturate EIA.
- Methadone: 75 ng/mL for LZI's BMBP EIA, 15 ng/mL for LZI's Methadone EIA.
- Benzodiazepine: 25 ng/mL for LZI's BMBP EIA, 15 ng/mL for LZI's Benzodiazepine EIA.
- Propoxyphene: 50 ng/mL for LZI's BMBP EIA, 15 ng/mL for LZI's Propoxyphene EIA.
- Accuracy (Agreement):
- Barbiturate - Positive Samples: 100 % agreement (Vs. LZI Barbiturate EIA), 91.1 % agreement (Vs. a commercial EIA).
- Barbiturate - Negative Samples: 92.5 % agreement (Vs. LZI Barbiturate EIA), 100 % agreement (Vs. a commercial EIA).
- Methadone - Positive Samples: 100 % agreement (Vs. LZI Methadone EIA), 100 % agreement (Vs. a commercial EIA).
- Methadone - Negative Samples: 95.0 % agreement (Vs. LZI Methadone EIA), 100 % agreement (Vs. a commercial EIA).
- Benzodiazepine - Positive Samples: 100 % agreement (Vs. LZI Benzodiazepine EIA), 96.9 % agreement (vs. GC/MS /HPLC).
- Benzodiazepine - Negative Samples: 97.5 % agreement (Vs. LZI Benzodiazepine EIA), 84 % agreement (Vs. a commercial EIA).
- Propoxyphene - Positive Samples: 100 % agreement (Vs. LZI Propoxyphene EIA), 100 % agreement (Vs. a commercial EIA).
- Propoxyphene - Negative Samples: 97.5 % agreement (Vs. LZI Propoxyphene EIA), 100 % agreement (Vs. a commercial EIA).
- Analytical Recovery: 100 % accuracy on positive vs. negative tests.
- Specificity: See attached Assay package insert, Comparable to the predicate device.
Predicate Device(s)
K032764, K023317, K032365, K023795
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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
MAY 1 9 2004
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 Fax:(408) 732-3849
Contact: Cheng-I Lin, Ph.D. President, R&D Director
Device Name and Classification
| 1. Classification Name: | Barbiturate, Methadone, Benzodiazepine, and
Propoxyphene test systems |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Barbiturate test system has been placed in Class II by the
Bureau of Medical Devices.
Classification Number: DIS (21 CFR 862.3150)
Panel: 91 Toxicology |
| | The Methadone test system has been placed in Class II by the
Bureau of Medical Devices.
Classification Number: DJR (21 CFR 862.3620)
Panel: 91 Toxicology |
| | The Benzodiazepine test system has been placed in Class II by
the Bureau of Medical Devices.
Classification Number: JXM (21 CFR 862.3170)
Panel: 91 Toxicology |
| | The Propoxyphene test system has been placed in Class II by
the Bureau of Medical Devices.
Classification Number: JXN (21 CFR 862.3700)
Panel: 91 Toxicology |
1
| Common Name: | Homogeneous enzyme immunoassay for the detection of
barbiturates, methadone, benzodiazepines, and propoxyphene
in human urine. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | BMBP Enzyme Immunoassay |
Legally Marketed Predicate Device(s)
Lin-Zhi International, Inc.'s Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is substantially equivalent to the individual Barbiturate Enzyme Immunoassay, Methadone Enzyme Immunoassay, Benzodiazepine Enzyme Immunoassay, and Propoxyphene Enzyme Immunoassay by Lin-Zhi International, Inc., cleared under premarket notification K032764 (Barbiturate Enzyme Immunoassay), K023317 (Methadone Enzyme Immunoassay), K032365 (Benzodiazepine Enzyme Immunoassay), and K023795 (Propoxyphene Enzyme Immunoassay).
LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is similar to their predicates in terms of intended use, method principle, device components, and clinical performance.
Device Description
LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect barbiturates, methadone, benzodiazepines, and propoxyphene drugs in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between drug 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 enzymc 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 convert nicotinamide adenine dinucleotide (NAD) to NADH.
Intended Use
The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay, with 200 ng/mL cutoff for secobarbital, 300 ng/mL cutoff for methadone, 200 ng/mL cutoff for oxazepam, and 300 ng/mL cutoff for propoxyphene. The assay is solely intended for use in the qualitative screening human urine samples for the presence of barbiturates, methadone, benzodiazepine, and propoxyphene drugs.
2
Comparison to Predicate Device
LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is substantially equivalent to the individual single analyte assay products in commercially distribution intended for similar use. Most notably it is substantially equivalent to the Barbiturate Enzyme Immunoassay, Methadone Enzyme Immunoassay, Benzodiazepine Enzyme Immunoassay, and Propoxyphene Enzyme Immunoassay by Lin-Zhi International, Inc., cleared under pre-market notification K032764 (Barbiturate Enzyme Immunoassay), K0233174(Methadone Enzyme Immunoassay), K032365 (Benzodiazepine Enzyme Immunoassay), and K023795 (Propoxyphene Enzyme Immunoassay).
The following table compares LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay with the predicate devices, Barbiturate Enzyme Immunoassay, Methadone Enzyme Immunoassay, Benzodiazepine Enzyme Immunoassay, and Propoxyphene Enzyme Immunoassay by Lin-Zhi International, Inc.
Similarities:
- Both assays are used for qualitative detection of drug in human urine. .
- Both have same cutoff design (200 ng/mL for secobarbital, 300 ng/mL for . methadone, 200 ng/mL for oxazepam, and 300 ng/mL for propoxyphene).
- . Both assays use same control concentration.
- Both assays use the same method principle, and device components. .
Difference:
- . Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is designed for qualitative screening purpose only.
- The assay is for positive/negative screening only. Positive samples need further . test to identify individual drug in the sample.
- Multiple analyte calibrators/controls cannot be use in this assay. .
- Any single analyte calibrators and controls (secobarbital, methadone, oxazepam, . or propoxyphene) can be used to verify and validate this assay.
3
Performance Characteristics
.
:
| Feature | LZI's BMBP EIA | LZI's Barbiturate EIA | ||||||
|---|---|---|---|---|---|---|---|---|
| Within Run Precision: | ||||||||
| (n=21) | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 598.8 | 3.52 | 0.59 | Negative | 269.1 | 2.16 | 0.80 | |
| 100 ng/mL | 625.2 | 5.53 | 0.88 | 100 ng/mL | 311.1 | 1.92 | 0.62 | |
| 200 ng/mL | 659.9 | 5.52 | 0.84 | 200 ng/mL | 354.2 | 3.71 | 1.05 | |
| 300 ng/mL | 679.2 | 5.47 | 0.81 | 300 ng/mL | 385.1 | 3.07 | 0.80 | |
| 1000 ng/mL | 722.9 | 3.79 | 0.52 | 1000 ng/mL | 445.3 | 2.69 | 0.60 | |
| Run-To-Run Precision: | ||||||||
| (n=12) | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 600.0 | 5.31 | 0.88 | Negative | 271.1 | 2.3 | 0.83 | |
| 100 ng/mL | 624.4 | 2.63 | 0.42 | 100 ng/mL | 314.8 | 2.2 | 0.69 | |
| 200 ng/mL | 653.3 | 4.18 | 0.64 | 200 ng/mL | 359.0 | 1.9 | 0.53 | |
| 300 ng/mL | 681.2 | 5.70 | 0.84 | 300 ng/mL | 389.5 | 1.6 | 0.42 | |
| 1000 ng/mL | 726.5 | 6.53 | 0.90 | 1000 ng/mL | 447.4 | 1.6 | 0.35 | |
| Sensitivity: | 50 ng/mL | 25 ng/mL | ||||||
| Accuracy: | Vs. LZI Barbiturate EIA | Vs. a commercial EIA | ||||||
| Positive Samples: 100 % agreement | 91.1 % agreement | |||||||
| Negative Samples: 92.5 % agreement | 100 % agreement | |||||||
| Analytical Recovery: | 100 % accuracy on positive vs. negative tests | 100 % accuracy on positive vs. negative tests | ||||||
| Specificity: | See attached Assay package insert | Comparable to the predicate device. |
| Feature | LZI's BMBP EIA | LZI's Methadone EIA | ||||||
|---|---|---|---|---|---|---|---|---|
| Within Run Precision: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| (n=21) | Negative | 596.3 | 4.27 | 0.72 | Negative | 209.4 | 1.0 | 0.49 |
| 225 ng/mL | 638.5 | 5.77 | 0.90 | 225 ng/mL | 272.8 | 1.1 | 0.39 | |
| 300 ng/mL | 657.3 | 3.80 | 0.58 | 300 ng/mL | 293.4 | 0.7 | 0.25 | |
| 375 ng/mL | 673.2 | 4.06 | 0.60 | 375 ng/mL | 308.2 | 0.9 | 0.29 | |
| 1000 ng/mL | 715.6 | 5.30 | 0.74 | 1000 ng/mL | 344.9 | 1.1 | 0.33 | |
| Run-To-Run Precision: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| (n=12) | Negative | 600.3 | 5.94 | 0.99 | Negative | 209.5 | 1.1 | 0.51 |
| 225 ng/mL | 640.0 | 5.45 | 0.85 | 225 ng/mL | 271.4 | 2.0 | 0.74 | |
| 300 ng/mL | 658.7 | 4.29 | 0.65 | 300 ng/mL | 292.3 | 1.9 | 0.66 | |
| 375 ng/mL | 673.3 | 5.30 | 0.79 | 375 ng/mL | 307.2 | 2.6 | 0.84 | |
| 1000 ng/mL | 707.3 | 5.00 | 0.71 | 1000 ng/mL | 344.1 | 2.0 | 0.58 | |
| Sensitivity: | 75 ng/mL | 15 ng/mL | ||||||
| Accuracy: | Vs. LZI Methadone EIA | Vs. a commercial EIA | ||||||
| Positive Samples: | 100 % agreement | 100 % agreement (100% vs. GC/MS /HPLC) | ||||||
| Negative Samples: | 95.0 % agreement | 100 % agreement | ||||||
| Analytical Recovery: | 100 % accuracy on positive vs. negative tests | 100 % accuracy on positive vs. negative tests | ||||||
| Specificity: | See attached Assay package insert | Comparable to the predicate device. |
:
4
| Feature | LZI's BMBP EIA | LZI's Benzodiazepine EIA | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Within Run Precision: | |||||||||
| (n=21) | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV | |
| Negative | 602.1 | 3.8 | 0.64 | Negative | 361.0 | 3.1 | 0.86 | ||
| 100 ng/mL | 635.7 | 3.6 | 0.56 | 100 ng/mL | 417.8 | 3.5 | 0.84 | ||
| 200 ng/mL | 655.9 | 4.5 | 0.68 | 200 ng/mL | 455.5 | 3.5 | 0.76 | ||
| 300 ng/mL | 683.7 | 4.6 | 0.68 | 300 ng/mL | 483.3 | 3.5 | 0.73 | ||
| 1000 ng/mL | 736.1 | 5.5 | 0.75 | 1000 ng/mL | 559.7 | 4.9 | 0.74 | ||
| Run-To-Run Precision: | |||||||||
| (n=12) | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV | |
| Negative | 600.8 | 5.0 | 0.83 | Negative | 360.0 | 2.5 | 0.70 | ||
| 100 ng/mL | 637.6 | 4.2 | 0.66 | 100 ng/mL | 417.9 | 2.5 | 4.42 | ||
| 200 ng/mL | 655.6 | 4.5 | 0.69 | 200 ng/mL | 457.0 | 1.9 | 0.51 | ||
| 300 ng/mL | 683.0 | 5.3 | 0.78 | 300 ng/mL | 483.6 | 2.4 | 0.55 | ||
| 1000 ng/mL | 739.0 | 7.0 | 0.95 | 1000 ng/mL | 561.8 | 3.3 | 0.58 | ||
| Sensitivity: | 25 ng/mL | 15 ng/mL | |||||||
| Accuracy: | Vs. LZI Benzodiazepine EIA | Vs. a commercial EIA | |||||||
| Positive Samples: | 100 % agreement | 96.9 % agreement(vs. GC/MS /HPLC) | |||||||
| Negative Samples: | 97.5 % agreement | 84 % agreement | |||||||
| Analytical Recovery: | 100 % accuracy on positive vs. negative tests | 100 % accuracy on positive vs. negative tests | |||||||
| Specificity: | See attached Assay package insert | Comparable to the predicate device. |
and the comments of the comments of the comments of the comments of
100 - 100 - 100
·
:
| Feature | LZI's BMBP EIA | LZI's Propoxyphene EIA | ||||||
|---|---|---|---|---|---|---|---|---|
| Within Run Precision: | ||||||||
| (n=21) | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 600.5 | 5.19 | 0.86 | Negative | 117.4 | 0.5 | 0.47 | |
| 225 ng/mL | 642.5 | 5.48 | 0.85 | 225 ng/mL | 225.1 | 1.3 | 0.59 | |
| 300 ng/mL | 656.8 | 5.54 | 0.84 | 300 ng/mL | 261.3 | 1.6 | 0.61 | |
| 375 ng/mL | 671.8 | 4.84 | 0.72 | 375 ng/mL | 287.7 | 1.5 | 0.51 | |
| 1000 ng/mL | 702.5 | 5.30 | 0.75 | 1000 ng/mL | 350.0 | 1.4 | 0.39 | |
| Run-To-Run Precision: | ||||||||
| (n=12) | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 599.5 | 4.2 | 0.70 | Negative | 116.8 | 1.0 | 0.88 | |
| 225 ng/mL | 642.1 | 4.3 | 0.67 | 220.8 | 220.8 | 2.4 | 1.07 | |
| 300 ng/mL | 657.7 | 4.8 | 0.73 | 300 ng/mL | 255.9 | 2.1 | 0.81 | |
| 375 ng/mL | 671.4 | 6.3 | 0.94 | 375 ng/mL | 285.1 | 2.2 | 0.76 | |
| 1000 ng/mL | 707.5 | 2.5 | 0.35 | 1000 ng/mL | 349.5 | 1.9 | 0.55 | |
| Sensitivity: | 50 ng/mL | 15 ng/mL | ||||||
| Accuracy: | Vs. LZI Propoxyphene EIA | Vs. a commercial EIA | ||||||
| Positive Samples: | ||||||||
| 100 % agreement | 100 % agreement(vs. GC/MS /HPLC) | |||||||
| Negative Samples: | ||||||||
| 97.5 % agreement | 100 % agreement | |||||||
| Analytical Recovery: | 100 % accuracy on positive vs. negative tests | 100 % accuracy on positive vs. negative tests | ||||||
| Specificity: | See attached Assay package insert | Comparable to the predicate device. |
5
Conclusion
The LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte 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 individual 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 Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay to other individual test systems for screening purpose currently marketed in the United States.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping bodies, representing the department's mission to protect the health of all Americans and provide essential human services.
MAY 1 9 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Cheng-I Lin, Ph.D. President Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085
Re: K033885
Trade/Device Name: Simultaneous Barbiturate- Methadonc-Benzodiazepine Propoxyphene(BMBP) Multiple Analyte Enzyme Immunoassay Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS, DJR, JXM, JXN Dated: April 21, 2004 Received: April 27, 2004
Dcar 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).
7
Page 2
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). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
MS, DVM
Jean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use Statement
510(k) Number (if known):
Device Name: Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay
Indications for Use:
The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay. The assay is solely intended for use in the qualitative screening human urine samples for the presence of barbiturates, methadone. benzodiazepines, and propoxyphene drugs. . The assay will produce a positive result if any of the four analyte are present at a concentration at or above their respective cutoffs but will not its its is is is is drug is present. The assay is solely intended for the qualitative screening of human writer for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of in divisiouals who have used barbiturates, methadone, benzodiazepines, and propoxyphene druation on mourvis designed for professional use with a number of automated clinical chemistry arralyzes.
The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. The assay will not identify which drug is present in the positive urine sample. All screening positive samples shall subject to minist assays to identify the drug in the sample before alternative confirmation. Gas chromations withings spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, when preliminary positive results are used.
Tan Cooper
ision Sign-Of
Office of In Vitro Diagnostic Device Office of Safety
510(k) Prescription Use AND/OR (Per 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of IN Vitro Diagnostic Device (OIVD)