(210 days)
No
The device description details a standard chemiluminescent enzyme immunoassay process, which is a biochemical method for detecting substances. There is no mention of AI, ML, or any computational algorithms that would suggest the use of these technologies for data analysis or interpretation beyond standard immunoassay calculations. The performance studies compare the device to other immunoassays, further indicating a traditional laboratory testing method.
No
The device is an in vitro diagnostic immunoassay designed for measuring cannabinoids in urine, not for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended strictly for in vitro diagnostic use".
No
The device description clearly states it is a solid-phase, chemiluminescent enzyme immunoassay that uses a polystyrene bead coated with an antibody and involves chemical reactions and a luminometer. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in both the "Intended Use / Indications for Use" and "Device Description" sections that the device is "intended strictly for in vitro diagnostic use".
N/A
Intended Use / Indications for Use
IMMULITE® Cannabinoids is a solid-phase, chemiluminescent enzyme immunoassay designed for use with the IMMULITE" Automated Analyzer for the semiquantitative and qualitative measurement for cannabinoids and metabolites in urine. It is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for tetrahvdrocannabinol (THC. cannabis, marijuana) and its metabolites
Product codes
LDJ, JJX
Device Description
IMMULITE® Cannabinoids is a solid-phase, chemiluminescent enzyme immunoassay. The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with a monoclonal antibody specific for cannabinoids. The patient sample and alkaline phosphatase-conjugated 11-nor-A -tetrahvdrocannabinol-9-carboxylic acid (THCA) are simultaneously introduced into the Test Unit, and incubated for 30 minutes at 37°C with intermittent agitation. During this time, cannabinoids in the sample compete with the enzyme-labeled THC for a limited number of antibody binding sites on the bead. Unbound enzyme conjugate is then removed by a centrifugal wash, after which substrate is added and the Test Unit is incubated for a further 10 minutes. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to vield an unstable intermediate. The continuous production of this intermediate results in a sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output as measured by the luminometer - is inversely proportional to the concentration of cannabinoids in the sample.
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
Not Found
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
Randomly selected drug-free and drug-containing urine samples were obtained from a Hospital in Switzerland, and tested on site.
Summary of Performance Studies
Method Comparison: The IMMULITE Cannabinoids procedure was compared to two commercially available immunoassays for cannabinoids, Roche Abuscreen OnLine THC and Abbott AxSYM Cannabinoids Assay on a total of 456 urine samples with a range from nondetectable to over 2500 ng/mL.
Key Results:
Roche Abuscreen Online:
Relative Sensitivity: 99.2%
Relative Specificity: 98.2%
The two cases where IMMULITE results were negative and Roche results were positive were both found nondetectable by the GC/MS procedure. The GC/MS values for the four cases where IMMULITE results were positive and Roche results were negative ranged from nondetectable to 80 ng/mL.
Abbott AxSYM:
Relative Sensitivity: 96.3%
Relative Specificity: 99.0%
The nine cases where IMMULITE results were negative and Abbott AxSYM results were positive were all found nondetectable by the GC/MS procedure. The two cases where IMMULITE results were positive and Abbott AxSYM results were negative were both 18 ng/mL in the GC/MS procedure.
Key Metrics
Relative Sensitivity, Relative Specificity
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045 Tel: (213) 776-0180 Fax: (213) 776-0204
APR 28 1997
第一次
上一篇:
上一篇:
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 Part 807.92.
| Name: | Diagnostic Products Corporation (DPC) |
|---|---|
| Address: | 5700 West 96th Street |
| Los Angeles, CA 90045-5597 | |
| Telephone Number | (213) 776-0180 |
| Facsimile Number: | (213) 776-0204 |
| Contact Person: | Edward M. Levine, Ph.D. |
| Director of Clinical Affairs | |
| Date of Preparation: | April 3, 1997 |
| Device Name: | |
| Trade: | IMMULITE® Cannabinoids |
| Catalog #: | LKTHI (100 tests), LKTH5 (500 tests) |
| Common: | Reagent system designed as a semiquantitative |
| measurement for cannabinoids in urine. | |
| CFR: | A device intended to measure any of the cannabinoids, |
| hallucinogenic compounds endogenous to marijuana, in | |
| serum, plasma, saliva, and urine. Cannabinoid | |
| compounds include delta-9-tetrahydrocannabinol, | |
| cannabidiol, cannabinol, and cannbichromene | |
| Measurements obtained by this device are used in the | |
| diagnosis and treatment of cannabinoid use or abuse and | |
| in monitoring levels of cannabinoids during clinical | |
| investigational use. | |
| Classification: | Class II device (21 CFR 862.3870), 91-LDJ |
| Panel: | Toxicology |
| Accessory Trade: | IMMULITE® Cannabinoids Control Module |
| Common: | Quality Control Material (assayed & unassayed) |
| CFR: | A device intended for medical purposes for use in a test |
| system to estimate test precision and to detect systematic | |
| analytical deviations that may arise from reagent or | |
| analytical instrument variation. | |
| Classification: | Class I device (21 CFR 862.1660), 82-JJX |
| Panel: | Immunology |
Image /page/0/Picture/6 description: The image shows a logo with the letters "DPC" in a bold, sans-serif font. The letters are connected to each other, forming a single, solid shape. There is a registered trademark symbol in the upper right corner of the logo. The logo is black and the background is white.
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Diagnostic Products Corporation 00 West 96th Street oneles CA 9004 2131 776-0180
| Manufacturer: | Diagnostic Products Corporation (DPC)
5700 West 96th Street
Los Angeles. CA 90045-5597 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration #: | DPC: 2017183 |
| Substantial Equivalent
Predicate Device: | Roche Abuscreen Online THC (K961620)
Abbott AxSYM Cannabinoids (K951288)
and DPC's Third Generation TSH
Control Module (K930007) |
Description and Intended Use of Device:
IMMULITE® Cannabinoids is a solid-phase, chemiluminescent enzyme immunoassay designed for use with the IMMULITE" Automated Analyzer for the semiquantitative and qualitative measurement for cannabinoids and metabolites in urine. It is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for tetrahvdrocannabinol (THC. cannabis, marijuana) and its metabolites
Substantial Equivalence Claim:
Diagnostic Products Corporation (DPC) asserts that DPC's IMMULITE* Cannabinoids is substantially equivalent to Roche Abuscreen Online THC and Abbott AxSYM Cannabinoids assays.
Intended Use Equivalence:
The IMMULITE Cannabinoids assay is designed for the semiguantitative and qualitative measurement of cannabinoids in urine. Abuscreen Online THC is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine and the AxSYM Cannabinoids assay is a semiquantitative reagent system for the detection of cannabinoids in human urine. Each product is intended strictly for in vitro diagnostic use, and each product provides a preliminary analytical test result
2
iagnostic Products Corporation nn West 96th Street Angeles, CA 9004 ax: (213) 776-0204
Technological Comparison to Predicate:
The IMMULITE* Cannabinoids is a chemiluminescent immunoassay. The technology of the IMMULITE® Cannabinoids assay is identical to the technology used in previously cleared and commercially marketed IMMULITE® products.
IMMULITE® Cannabinoids is a solid-phase. chemiluminescent immunoassay. The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with a monoclonal antibody specific for cannabinoids. The patient sample and alkaline phosphatase-conjugated 11-nor-A -tetrahvdrocannabinol-9-carboxylic acid (THCA) are simultaneously introduced into the Test Unit, and incubated for 30 minutes at 37°C with intermittent agitation. During this time, cannabinoids in the sample compete with the enzyme-labeled THC for a limited number of antibody binding sites on the bead. Unbound enzyme conjugate is then removed by a centrifugal wash, after which substrate is added and the Test Unit is incubated for a further 10 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to vield an unstable intermediate. The continuous production of this intermediate results in a sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output as measured by the luminometer - is inversely proportional to the concentration of cannabinoids in the sample.
Abuscreen Online Automated Assays are based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, free antibody binds to drug-microparticle conjugates, causing the formation of particle aggregates When a urine sample containing the drug in question is present, this drug competes with the particle-bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited.
As the aggregation reaction proceeds in the absence of sample drug, the absorbance change increases. Conversely the presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
The AxSYM Cannabinoids assay utilizes fluorescence Polarization Immunoassay (FPIA) technology. In the FPIA reaction process, specimen analyte-tracer compete for binding sites on antibodies. If the specimen contains a high concentration of the analyte, then specimen analyte binds to the antibodies, leaving the analyte-tracer unbound. If the specimen contains a low concentration (or no concentration) of the analyte. then few or no analyte molecules bind to the antibodies. leaving the antibodies open for the analyte-tracer to bind. FPIA optics measure the change in polarized light to determine the concentration of unbound analyte-tracers. and therefore the concentration of analytes in the specimen (fluorescence polarization).
3
Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045
Tel: (213) 776-0180
Fax: (213) 776-0204
Performance Equivalence - Method Comparison
The IMMULITE Cannabinoids procedure was compared to two commercially available immunoassays for cannabinoids, Roche Abuscreen OnLine THC and Abbott AxSYM Cannabinoids Assay on a total of 456 urine samples with a range from nondetectable to over 2500 ng/mL. Randomly selected drug-free and drug-containing urine samples were obtained from a Hospital in Switzerland, and tested on site. The results of the comparisons are presented in the tables below
| IMMULITE Cannabinoids | Relative | Relative | |||
|---|---|---|---|---|---|
| Pos. | Neg. | Sensitivity | Specificity | ||
| Roche Abuscreen | Pos. | 235 | 2 | 99.2% | 98.2% |
| Online | Neg. | 4 | 215 |
The two cases where IMMULITE results were negative and Roche results were positive were both found nondetectable by the GC/MS procedure. The GC/MS values for the four cases where IMMULITE results were positive and Roche results were negative ranged from nondetectable to 80 ng/mL.
| IMMULITE Cannabinoids | Relative | Relative | ||
|---|---|---|---|---|
| Pos. | Neg. | Sensitivity | Specificity | |
| Abbott AxSYM Pos. | 237 | 9 | 96.3% | 99.0% |
| Neg. | 2 | 208 |
The nine cases where IMMULITE results were negative and Abbott AxSYM results were positive were all found nondetectable by the GC/MS procedure. The two cases where IMMULITE results were positive and Abbott AxSYM results were negative were both 18 ng/mL in the GC/MS procedure.
4
in Products Cornoration
Substantial Equivalence Claim for the IMMULITE Cannabinoids Control Module
Diagnostic Products Corporation (DPC) asserts that the IMMULITE Cannabinoids Control Module, which is sold separately from the IMMULITE Cannabinoids kit, is substantially equivalent to other commercially available assayed controls, such as DPC's Third Generation TSH Control Module (K930007).
Intended Use Equivalence:
Each product is designed for monitoring day-to-day performance of a particular assay. Each product is intended strictly for in vitro diagnostic use, and is supplied lyophilized. requiring reconstitution.
The controls are intended to be assayed as an unknown, in the same manner as a patient sample, in the context of an internal quality control program
Clinical Studies:
Not applicable
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is safe, effective, and performs as well as or better than the legally marketed device.
Edward Loomis
Edward M. Levine, Ph.D.
Director of Clinical Affairs
4/4/97
Dute