(117 days)
Not Found
No
The device description details a homogeneous enzyme immunoassay based on chemical reactions and spectrophotometric measurements, with no mention of AI or ML.
No.
The device is for in vitro diagnostic (IVD) use, specifically for qualitative screening of human urine for certain analytes to aid in diagnosis, not for direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis and treatment of individuals who have used cocaine, amphetamines, opiates, or phencyclidine."
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 / Indications for Use" section explicitly states that the assay is "solely intended for the qualitative screening of human urine for these analytes." It also mentions that "Measurements obtained by this device are used in the diagnosis and treatment of individuals who have used cocaine, amphetamines, opiates, or phencyclidine." 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 analytes in "human urine." This describes a 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 analyzers," which are typically found in clinical laboratory settings where IVD tests are performed.
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 Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay with 300 ng/mL cutoff for cocaine metabolite, 1000 ng/mL cutoff for amphetamines, 300 ng/mL cutoff for opiates, and 25 ng/mL cutoff for phencyclidine. 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 identify which drug is present. The assay is solely intended for the qualitative screening of human urine for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of individuals who have used cocaine, amphetamines, opiates, or phencyclidine. The assay is designed for professional use with a number of automated clinical chemistry analyzers,
The Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method for the individual drugs must be used to obtain a confirmed analytiral 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 preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
DIO, DJG, DZK, LCM
Device Description
LZI's Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect cocaine metabolite, amphetamines, opiate r ic assay uses specific analo rine 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 I he ussay is based on componities and free drug from the urine sample for a fixed amount of ucific antibody. In the absence of free drug from the urine sample the specific antibody specific antiboury. In the dobtDH 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use with a number of automated clinical chemistry analyzers,
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The LZI's Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity:
Cocaine metabolite: 50 ng/mL
Amphetamines: 100 ng/mL
Opiate: 15 ng/mL
Phencyclidine: 1 ng/mL
Accuracy:
Cocaine metabolite:
Positive Samples: 100 % agreement
Negative Samples: 100 % agreement
Analytical Recovery: 100 % agreement on positive vs. negative tests
Amphetamines:
Positive Samples: 100 % agreement (100% vs. GC/MS /HPLC)
Negative Samples: 100 % agreement
Analytical Recovery: 100 % agreement on positive vs. negative tests
Opiate:
Positive Samples: 97.1 % agreement (100% vs. GC/MS /HPLC)
Negative Samples: 93.8 % agreement
Analytical Recovery: 100 % agreement on positive vs. negative tests
Phencyclidine:
Positive Samples: 100 % agreement (100% vs. GC/MS /HPLC)
Negative Samples: 100 % agreement
Analytical Recovery: 100 % agreement on positive vs. negative tests
Specificity:
Cocaine metabolite: See attached Assay package insert
Amphetamines: Comparable to the predicate device.
Opiate: See attached Assay package insert
Phencyclidine: 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.
K020763, K020369, K020368, K020254
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
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name, Address, and Contact
Lin-Zhi International, Inc. 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
| 1. Classification Name: | Cocaine Metabolite, Amphetamines, Opiate, and
Phencyclidine test system, |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Cocaine and Cocaine Metabolite test system has been
placed in Class II by the Bureau of Medical Devices.
Classification Number: DIO (21 CFR 862.3250)
Panel: 91 Toxicology |
| | The Amphetamine test system has been placed in Class II by
the Bureau of Medical Devices.
Classification Number: DKZ (21 CFR 862.3100)
Panel: 91 Toxicology |
| | The Opiate test system has been placed in Class II by the
Bureau of Medical Devices.
Classification Number: DJG (21 CFR 862.3650)
Panel: 91 Toxicology |
| | The Phencyclidine test system
Classification Number: LCM
Panel: 91 Toxicology |
1
| Common Name: | Homogeneous enzyme immunoassay for the detection of
cocaine metabolite, amphetamines, opiate, and phencyclidine
in human urine. |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | CAMP Enzyme Immunoassay |
Legally Marketed Predicate Device(s)
Lin-Zhi International, Inc.'s Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Life-Zill Intentational, Inc. 3 Dimananovas Occaratially equivalent to Cocaine Metabolite Multiple Anaryto Enzynio Iminetamines Enzyme Immunoassay, Opiate Enzyme Enzyme Inimunoassay, Aniphotamilizzyme Immunoassay by Lin-Zhi International, Inc., minunoasay, and I nonoyonano izazjo2763 (Cocaine Metabolite Enzyme Immunoassay), cleared under premanter nouncalitation Prouvers (Opiate Enzyme Immunoassay), and K020254 (Phencyclidine Enzyme Immunoassay).
LZI's Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine 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 Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect cocaine metabolite, amphetamines, opiate r ic assay uses specific analo rine 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 I he ussay is based on componities and free drug from the urine sample for a fixed amount of ucific antibody. In the absence of free drug from the urine sample the specific antibody specific antiboury. In the dobtDH 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 Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay (CAMP) is a homogeneous enzyme immunoassay with 300 ng/mL Enzyme Innnunousber (Critics) 100 ng/mL cutoff for methamphetamine, 300 ng/mL cutoff for opiate, and 25 ng/mL cutoff for phencyclidine. The assay is solely intended for use in the qualitative screening for negative human urine samples for cocaine metabolite, amphetamines, opiate, and phencyclidine drugs.
2
Comparison to Predicate Device
LZI's Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay (CAMP) 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 Cocaine Metabolite Enzyme Immunoassay, Amphetamines Enzyme Immunoassay, Opiate Enzyme Immunoassay, and Phencyclidine Enzyme Immunoassay By Lin-Zhi International, Inc., cleared under premarket notification K020763 (Cocaine Metabolite Enzyme Immunoassay), K020369 (Amphetamines Enzyme Immunoassay), K020368 (Opiate Enzyme Immunoassay), and K020254 (Phencyclidine Enzyme Immunoassay).
The following table compares LZI's Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay (CAMP) with the predicate devices, Cocaine Metabolite Enzyme Immunoassay, Amphetamines Enzyme Immunoassay, Opiate Enzyme Immunoassay, and Phencyclidine 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 (300 ng/mL for cocaine metabolite, 1000 ng/mL . for methamphetamine, 300 ng/mL for opiate, and 25 ng/mL for phencyclidine).
- Both assays use same control concentration (+/- 25% of cut-off value). .
- Both assays use the same method principle, and device components. ●
Difference:
- Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple . Analyte Enzyme Immunoassay is designed for qualitative screening purpose only.
- Multiple analyte calibrators/controls cannot be use in this assay. .
- The CAMP assay should be calibrated with Opiate calibrators only. ●
3
| Feature | LZI s CAMP EIA | LZI's Cocaine Metabolite EIA | Feature | LZI's CAMP EIA | LZI's Amphetamines EIA | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Within Run Precision: | |||||||||||||||||
| (n=21) | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV | Within Run Precision: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 736.3 | 5.5 | 0.75 | Negative | 243.7 | 0.9 | 0.37 | (n=21) | Negative | 734.7 | 6.2 | 0.85 | Negative | 273.0 | 1.0 | 0.35 | |
| 225 ng/mL | 786.2 | 5.1 | 0.65 | 225 ng/mL | 356.8 | 1.8 | 0.50 | 750 ng/mL | 793.0 | 6.4 | 0.81 | 750 ng/mL | 390.0 | 1.4 | 0.37 | ||
| 300 ng/mL | 803.6 | 7.7 | 0.96 | 300 ng/mL | 380.2 | 1.8 | 0.48 | 1000 ng/mL | 804.0 | 4.9 | 0.60 | 1000 ng/mL | 415.7 | 1.4 | 0.34 | ||
| 375 ng/mL | 811.9 | 7.0 | 0.86 | 375 ng/mL | 397.3 | 2.2 | 0.56 | 1250 ng/mL | 810.2 | 5.9 | 0.73 | 1250 ng/mL | 439.0 | 1.6 | 0.37 | ||
| 3000 ng/mL | 876.8 | 5.3 | 0.61 | 3000 ng/mL | 488.4 | 1.8 | 0.36 | 2000 ng/mL | 825.5 | 5.7 | 0.69 | 2000 ng/mL | 480.5 | 1.4 | 0.30 | ||
| Run-To-Run Precision: | |||||||||||||||||
| (n=12) | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV | Run-To-Run Precision: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 742.4 | 3.5 | 0.48 | Negative | 243.1 | 0.9 | 0.36 | (n=12) | Negative | 742.4 | 3.5 | 0.48 | Negative | 272.9 | 2.3 | 0.8 | |
| 225 ng/mL | 793.4 | 5.1 | 0.65 | 225 ng/mL | 354.8 | 2.4 | 0.67 | 750 ng/mL | 792.8 | 4.3 | 0.54 | 750 ng/mL | 390.5 | 2.9 | 0.7 | ||
| 300 ng/mL | 806.9 | 4.4 | 0.55 | 300 ng/mL | 377.0 | 3.5 | 0.93 | 1000 ng/mL | 799.0 | 3.8 | 0.47 | 1000 ng/mL | 415.9 | 3.0 | 0.5 | ||
| 375 ng/mL | 822.1 | 7.0 | 0.85 | 375 ng/mL | 394.6 | 2.1 | 0.53 | 1250 ng/mL | 808.9 | 6.1 | 0.76 | 1250 ng/mL | 439.1 | 3.6 | 0.4 | ||
| 3000 ng/mL | 882.3 | 5.5 | 0.62 | 3000 ng/mL | 486.0 | 2.4 | 0.49 | 2000 ng/mL | 828.4 | 3.3 | 0.40 | 2000 ng/mL | 479.6 | 3.5 | 0.4 | ||
| Sensitivity: | 50 ng/mL | 4 ng/mL | Sensitivity: | 100 ng/mL | 30 ng/mL | ||||||||||||
| Accuracy: | Vs. LZI Cocaine metabolite EIA | Vs. a commercial EIA | Accuracy: | Vs. LZI Amphetamines EIA | Vs. a commercial EIA | ||||||||||||
| Positive Samples: | 100 % agreement | 100 % agreement | Positive Samples: | 100 % agreement | 100 % agreement (100% vs. GC/MS /HPLC) | ||||||||||||
| Negative Samples: | 100 % agreement | 100 % agreement | Negative Samples: | 100 % agreement | 100 % agreement | ||||||||||||
| Analytical Recovery: | 100 % agreement on positive vs. negative tests | 100 % agreement on positive vs. negative tests | Analytical Recovery: | 100 % agreement on positive vs. negative tests | 100 % agreement on positive vs. negative tests | ||||||||||||
| Specificity: | See attached Assay package insert | Comparable to the predicate device. | Specificity: | See attached Assay package insert | Comparable to the predicate device. |
Performance Characteristics
4
| Feature | LZI's CAMP EIA | LZI's Opiate EIA | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Within Run Precision: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV | |
| (n=21) | Negative | 736.0 | 6.6 | 0.90 | Negative | 291.6 | 2.19 | 0.75 | |
| 225 ng/mL | 782.4 | 7.2 | 0.92 | 225 ng/mL | 374.4 | 3.01 | 0.80 | ||
| 300 ng/mL | 801.8 | 7.4 | 0.92 | 300 ng/mL | 399.8 | 3.42 | 0.86 | ||
| 375 ng/mL | 817.5 | 6.4 | 0.78 | 375 ng/mL | 421.8 | 3.20 | 0.76 | ||
| 1000 ng/mL | 878.7 | 5.9 | 0.67 | 1000 ng/mL | 530.8 | 5.17 | 0.97 | ||
| Run-To-Run Precision: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV | |
| (n=12) | Negative | 742.4 | 3.5 | 0.489 | Negative | 292.8 | 1.81 | 0.62 | |
| 225 ng/mL | 793.0 | 6.5 | 0.81 | 225 ng/mL | 375.8 | 3.61 | 0.96 | ||
| 300 ng/mL | 809.1 | 4.6 | 0.01 | 300 ng/mL | 400.8 | 3.34 | 0.83 | ||
| 375 ng/mL | 819.8 | 3.1 | 0.37 | 375 ng/mL | 421.1 | 2.87 | 0.68 | ||
| 1000 ng/mL | 886.0 | 6.2 | 0.69 | 1000 ng/mL | 528.6 | 4.84 | 0.92 | ||
| Sensitivity: | 50 ng/mL | 15 ng/mL | |||||||
| Accuracy: | Vs. LZI Opiate EIA | Vs. a commercial EIA | |||||||
| Positive Samples: | 100 % agreement | 97.1 % agreement (100% vs. GC/MS /HPLC) | |||||||
| Negative Samples: | 100 % agreement | 93.8 % agreement | |||||||
| Analytical Recovery: | 100 % agreement on positive vs. negative tests | 100 % agreement on positive vs. negative tests | |||||||
| Specificity: | See attached Assay package insert | Comparable to the predicate device |
·
| Feature | LZI's CAMP EIA | LZI's Phencyclidine EIA | ||||||
|---|---|---|---|---|---|---|---|---|
| Within Run Precision: | ||||||||
| (n=21) | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 735.1 | 6.2 | 0.84 | Negative | 168.0 | 0.68 | 0.41 | |
| 18 ng/mL | 789.6 | 6.2 | 0.78 | 18 ng/mL | 238.6 | 1.16 | 0.49 | |
| 25 ng/mL | 799.2 | 5.2 | 0.66 | 25 ng/mL | 264.6 | 1.19 | 0.45 | |
| 32 ng/mL | 809.3 | 7.0 | 0.87 | 32 ng/mL | 282.8 | 1.42 | 0.50 | |
| 100 ng/mL | 833.5 | 6.3 | 0.76 | 100 ng/mL | 341.2 | 0.73 | 0.21 | |
| Run-To-Run Precision: | ||||||||
| (n=12) | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV |
| Negative | 742.4 | 3.4 | 0.48 | Negative | 168.0 | 0.90 | 0.54 | |
| 18 ng/mL | 794.1 | 5.0 | 0.63 | 18 ng/mL | 238.8 | 0.55 | 0.23 | |
| 25 ng/mL | 804.9 | 5.1 | 0.63 | 25 ng/mL | 264.6 | 0.79 | 0.30 | |
| 32 ng/mL | 814.0 | 4.6 | 0.57 | 32 ng/mL | 284.1 | 0.87 | 0.31 | |
| 100 ng/mL | 829.1 | 4.7 | 0.56 | 100 ng/mL | 340.1 | 1.07 | 0.32 | |
| Sensitivity: | 3 ng/mL | 1 ng/mL | ||||||
| Accuracy: | Vs. LZI Phencyclidine EIA | Vs. a commercial EIA | ||||||
| Positive Samples: | 100 % agreement | 100 % agreement(100% vs. GC/MS /HPLC) | ||||||
| Negative Samples: | 100 % agreement | 100 % agreement | ||||||
| Analytical Recovery: | 100 % agreement on positive vs. negative tests | 100 % agreement on positive vs. negative tests | ||||||
| Specificity: | See attached Assay package insert | Comparable to the predicate device |
5
Conclusion
The LZI's Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine 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 Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay to other individual test systems for screening purpose currently marketed in the United States.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol is composed of thick, black lines and curves, giving it a modern and minimalist appearance.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 7 2004
Cheng-I Lin, Ph.D. President, R&D Director Lin-Zhi International. Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085
Re: K033866
Trade/Device Name: Simultaneous Cocaine- Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO, DJG, DZK, LCM Dated: March 19, 2004 Received: March 23, 2004
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 indictions for use stated in the enclosure) to legally marketed predicate devices marketed in intenstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendonstity, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or to 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, I isting 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 Do- ' ur .
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
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.
Radiological Health
Jean M. Cooper, MS, DVM.
Yean 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
Enclosure
8
Premarket Notification
Indications for Use
510(k) Number (if known): K033866
Device Name: Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay
Indications for Use:
The Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay with 300 ng/mL cutoff for cocaine metabolite, 1000 ng/mL cutoff for amphetamines, 300 ng/mL cutoff for opiates, and 25 ng/mL cutoff for phencyclidine. 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 identify which drug is present. The assay is solely intended for the qualitative screening of human urine for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of individuals who have used cocaine, amphetamines, opiates, or phencyclidine. The assay is designed for professional use with a number of automated clinical chemistry analyzers,
The Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method for the individual drugs must be used to obtain a confirmed analytiral 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 preliminary positive results are used.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033866
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)