(266 days)
Not Found
No
The summary describes a standard immunoassay and automated analyzer, with no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic (IVD) immunoassay designed to screen for opiates in urine, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states: "It is intended strictly for in vitro diagnostic use".
No
The device description explicitly states it is a "solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Analyzer," indicating it is a physical assay kit and requires a specific hardware analyzer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "It is intended strictly for in vitro diagnostic use".
N/A
Intended Use / Indications for Use
Reagent system designed as a semi-quantitative screen for morphine-3-glucuronide in urine.
A device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucuronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring levels of opiate administration to ensure the appropriate therapy.
IMMULITE® Opiates SceenOpiates Screen is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Analyzer and is designed for use as a semi-quantitative screen for opiates 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 opiates.
IMMULITE® Opiates Screen Control Module: A device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that mav arise from reagent or analytical instrument variation.
DPC's Opiates Screen Control Module is an assayed, bi-level control intended strictly for in vitro use in monitoring the performance and accuracy of the IMMULITE Opiates Screen assay.
Product codes
DJG, JJX
Device Description
IMMULITE® Opiates SceenOpiates Screen is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Analyzer. The IMMULITE® Opiates Screen Control Module is an assayed, bi-level control supplied in liquid form, in 2 mL aliquots, and sold separately from the IMMULITE Opiates Screen Kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine, Blood, Serum, Gastric contents, Saliva
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
The IMMULITE Opiates Screen procedure was compared to two commercially available immunoassays for opiates (Roche Abuscreen OnLine, manufactured by Roche Diagnostic Systems and Emit d.a.u. Opiate Assay, manufactured by Syva) and GC/MS on a total of 618 urine samples with a range from nondetectable to over 1000 ng/mL. Randomly selected drug-free and drug-containing urine samples were obtained from the Uddevalla Hospital in Uddevalla Sjukhus, Switzerland and tested on site.
Summary of Performance Studies
Method Comparison: The IMMULITE Opiates Screen procedure was compared to two commercially available immunoassays for opiates (Roche Abuscreen OnLine, manufactured by Roche Diagnostic Systems and Emit d.a.u. Opiate Assay, manufactured by Syva) and GC/MS on a total of 618 urine samples.
Comparison with Roche Abuscreen OnLine: 240 positive and 363 negative results. Agreement: 97.6%. 95% Confidence Limits for Relative Sensitivity and Specificity, respectively: 92.8% - 98.1% and 96.9% - 99.6%.
Comparison with Syva Emit: 241 positive and 367 negative results (IMMULITE). Agreement: 98.4%. 95% Confidence Limits for Relative Sensitivity and Specificity, respectively: 94.8% - 99.1% and 97.3% - 99.7%.
Comparison with GC/MS: 230 positive and 368 negative results (IMMULITE). Agreement: 96.8%. 95% Confidence Limits for Sensitivity and Specificity, respectively: 95.1% - 99.3% and 93.6% - 97.8%.
In the comparison between IMMULITE and Roche Abuscreen OnLine, 8 of the 10 "false negative" cases were negative by GC/MS and 2 of the 5 "false positive" cases were positive by GC/MS. In the comparison between IMMULITE and Syva Emit, 2 of the 6 "false negative" cases were negative by GC/MS and none of the 4 "false positive" cases were positive by GC/MS.
Clinical Studies: Not applicable
Key Metrics
Relative Sensitivity (IMMULITE vs Roche): 96.0%
Relative Specificity (IMMULITE vs Roche): 98.6%
Relative Sensitivity (IMMULITE vs Syva Emit): 97.6%
Relative Specificity (IMMULITE vs Syva Emit): 98.9%
Sensitivity (IMMULITE vs GC/MS): 97.9%
Specificity (IMMULITE vs GC/MS): 96.1%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
KA62323
Diagnostic Products Corporation 700 West 96th Street Angeles, CA 90045 (213) 776-0180 (213) 776-0204
MAR 1 0 1997
Diagnostic Products Corporation (DPC)
510 (k) Summary of Safety and Effectiveness
5700 West 96th Street
Edward M. Levine, Ph.D.
Director of Clinical Affairs
IMMULITE® Opiates Screen
LKOS 1 (100 tests), LKOS5 (500 tests)
for morphine-3-glucuronide in urine.
Reagent system designed as a semi-quantitative screen
A device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucuronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring
levels of opiate administration to ensure
Los Angeles, CA 90045-5597
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.
(213) 776-0180
(213) 776-0204
January 23, 1997
the
appropriate therapy.
Toxicology .
Name of Manufacturer
Address:
Telephone Number: Facsimile Number:
Contact Person:
Date of Preparation:
Device Name:
Trade: Catalog #: Common:
CFR:
Classification: Panel:
Accessory Trade Name: Catalog #: 4 i Common: CFR:
Classification: Panel:
IMMULITE® Opiates Screen Control Module LOSCM (2 vials x 2 mL)
Class II device (21 CFR 862.3650), 91-DJG
Ouality Control Material (assayed & unassaved)
A device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that mav arise from reagent or analytical instrument variation.
Class I device (21 CFR 862.1660), 82-JJX Immunology
1
| Establishment Registration #: | DPC: 2017183 |
|---|---|
| Substantial Equivalent | |
| Predicate Device: | Emit d.a.u. Opiate Assay MultiPak (K842677), |
| manufactured by Syva Co. Palo Alto, CA | |
| Description and | |
| Intended Use of Device: | IMMULITE® Opiates SceenOpiates Screen is a |
| solid-phase, chemiluminescent enzyme immunoassay | |
| for use with the IMMULITE® Automated Analyzer | |
| and is designed for use as a semi-quantitative screen | |
| for opiates 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 | |
| opiates. |
Substantial Equivalence Claim:
Diagnostic Products Corporation (DPC) asserts that DPC's IMMULITE® Opiates Screen is substantially equivalent to Syva's Emit d.a.u. Opiates Assay MultiPak.
Intended Use Equivalence:
Each product is designed for the semi-quantitative measurement of opiates in urine. Each product is intended strictly for in vitro diagnostic use, and each product provides a preliminary analytical test result.
Method Comparison:
The IMMULITE Opiates Screen procedure was compared to two commercially available immunoassays for opiates (Roche Abuscreen OnLine, manufactured by Roche Diagnostic Systems and Emit d.a.u. Opiate Assay, manufactured by Syva) and GC/MS on a total of 618 urine samples with a range from nondetectable to over 1000 ng/mL. Randomly selected drug-free and drug-containing urine samples were obtained from the Uddevalla Hospital in Uddevalla Sjukhus, Switzerland and tested on site. The results of the comparisons are presented in the tables below.
Image /page/1/Figure/7 description: This image shows a table comparing the results of the IMMULITE Opiates Screen and Roche. The table shows the number of positive and negative results for each test, with 240 positive and 363 negative results. The relative sensitivity is 96.0% and the relative specificity is 98.6%.
Agreement: 97.6%
95% Confidence Limits for Relative Sensitivity and Specificity, respectively: 92.8% - 98.1% and 96.9% - 99.6%.
2
| IMMULITE Opiates Screen | Relative | Relative | |||
|---|---|---|---|---|---|
| Pos. | Neg. | Sensitivity | Specificity | ||
| Syva Emit | Pos. | 241 | 6 | 97.6% | 98.9% |
| Neg. | 4 | 367 |
Agreement: 98.4%
95% Confidence Limits for Relative Sensitivity and Specificity, respectively: 94.8% - 99.1% and 97.3% - 99.7%.
| IMMULITE Opiates Screen | |||||
|---|---|---|---|---|---|
| Pos. | Neg. | Sensitivity | Specificity | ||
| GC/MS | Pos. | 230 | 5 | 97.9% | 96.1% |
| Neg. | 15 | 368 |
Agreement: 96.8%
95% Confidence Limits for Sensitivity and Specificity, respectively: 95.1% - 99.3% and 93.6% - 97.8%.
In the comparison between IMMULITE and Roche Abuscreen OnLine, 8 of the 10 "false negative" cases were negative by GC/MS and 2 of the 5 "false positive" cases were positive by GC/MS. In the comparison between IMMULITE and Syva Emit, 2 of the 6 "false negative" cases were negative by GC/MS and none of the 4 "false positive" cases were positive by GC/MS
IMMULITE Opiates Screen Control Module
DPC's Opiates Screen Control Module is an assayed, bi-level control intended strictly for in vitro use in monitoring the performance and accuracy of the IMMULITE Opiates Screen assay. The two controls are supplied in liquid form, in 2 mL aliquots, and are sold separately from the IMMULITE Opiates Screen Kit.
The control values are lot-specific, i.e., the control values are established for each control lot. The values for the Opiate controls are targeted at approximately 195 and 453 ng/mL.
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 Kaine
Edward M. Levine, Ph.D.
Director of Clinical Affairs
1/28/97
Date