(190 days)
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No
The description details a standard immunoassay and automated analyzer for chemical measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) immunoassay for measuring cocaine metabolites in urine, not a device used for treating disease or maintaining health.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "It is intended strictly for in vitro diagnostic use."
No
The device is described as a "solid-phase, chemiluminescent enzyme immunoassay" designed for use with an "Automated Analyzer." This clearly indicates a physical, hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" and "Device Description" sections both explicitly state that the device is "intended strictly for in vitro diagnostic use".
- Measurement in Biological Sample: The device measures substances (benzoylecgonine and cocaine) in a biological sample (urine). This is a key characteristic of IVDs.
- Diagnostic Context: The intended use is "in the context of a program involving an established confirmatory test for cocaine and its principal metabolites," indicating its role in a diagnostic process.
- Comparison to Predicate IVD: The performance study compares the device to a "Predicate Device" which is also an IVD (DPC's Coat-A-Count (CAC) Cocaine Metabolite, K870740).
All of these points strongly indicate that the IMMULITE® Cocaine Metabolite is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IMMULITE® Cocaine Metabolite is a solid-phase, chemiluminescent enzyme immunoassay designed for use with the IMMULITE® Automated Analyzer for the semi-quantitative measurement of benzoylecgonine and its parent compound, cocaine, in urine. It is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for cocaine and its principal metabolites.
Product codes (comma separated list FDA assigned to the subject device)
91-DIO
Device Description
IMMULITE® Cocaine Metabolite is a solid-phase, chemiluminescent enzyme immunoassay designed for use with the IMMULITE® Automated Analyzer for the semi-quantitative measurement of benzoylecgonine and its parent compound, cocaine, in urine. The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with a monoclonal antibody specific for benzoylecgonine. The patient sample and alkaline phosphatase-conjugated benzoylecgonine are simultaneously introduced into the Test Unit, and incubated for 30 minutes at 37℃ with intermittent agitation. During this time, benzoylecgonine in the sample competes with the enzyme-labeled benzoylecgonine 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, PPD (a phosphate ester of adamantyl dioxetane), undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in a sustained emission of light. The bound complex - and thus also the photon output as measured by the luminometer - is inversely proportional to the concentration of benzoylecgonine in the sample.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
IMMULITE® Cocaine Metabolite procedure was compared to Coat-A-Count Cocaine Metabolite on a total of 351 urine samples obtained from a drug testing laboratory.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
A total of 351 urine samples were tested by both IMMULITE® Cocaine Metabolite and Coat-A-Count Cocaine Metabolite. Out of the 351 specimens, 229 were positive and 106 were negative by both methods. There were 11 instances where IMMULITE was negative and CAC was positive, and 5 instances where IMMULITE was positive and CAC was negative.
Confirmation Rate:
223 of the 234 specimens tested positive by the IMMULITE Cocaine Metabolite procedure were tested by the GC/MS procedure. 221 of the 223 IMMULITE positive specimens were found positive by the GC/MS procedure (cutoff 150 ng/mL), achieving a confirmation rate of 99% (221/223).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Confirmation rate of 99% (221/223) against GC/MS procedure for IMMULITE positive specimens.
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.
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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).
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§ 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
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597 Tel: (213) 776-0180 Fax: (213) 776-0204
8 1997
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: | September 27. 1996 | ||
| Trade: | IMMULITE® Cocaine Metabolite | ||
| Catalog Number: | LKCN1 (100 tests), LKCN5 (500 tests) | ||
| Common: | Reagent system designed for the semi-quantitative | ||
| analysis of benzoylecgonine, and its parent | |||
| compound, cocaine, in urine. | |||
| CFR: | 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. | |||
| Classification: | Class II device (862.3250), 91-DIO | ||
| Manufacturer: | Diagnostic Products Corporation (DPC) | ||
| 5700 West 96th Street | |||
| Los Angeles, CA 90045-5597 | |||
| Establishment Registration #: | 2017183 | ||
| Substantially Equivalent | |||
| Predicate Device: | DPC's Coat-A-Count (CAC) Cocaine Metabolite | ||
| (K870740) |
Description and Intended Use of Device:
IMMULITE® Cocaine Metabolite is a solid-phase, chemiluminescent enzyme immunoassay designed for use with the IMMULITE® Automated Analyzer for the semi-quantitative measurement of benzoylecgonine and its parent compound, cocaine, in urine. It is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for cocaine and its principal metabolites
Substantial Equivalence Claim:
Diagnostic Froducts Corporation (DPC) asserts that DPC's IMMULITE® Cocaine Metabolite is substantially equivalent to DPC's Coat-A-Count (CAC) Cocaine Metabolite.
Image /page/0/Picture/10 description: The image shows a logo with a globe in the background. In front of the globe, the number 25 is prominently displayed, signifying an anniversary. Below the number, the word "YEARS" is written. The phrase "EXCELLENCE IN DIAGNOSTICS" is written around the globe.
1
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597 Tel: Fax: (213) 776-0204
Intended Use Equivalence:
Image /page/1/Picture/2 description: The image shows the logo for DPC. The letters are in a bold, sans-serif font and are all capitalized. The letters are black and the background is white. There is a registered trademark symbol in the upper right corner of the logo.
Each product is designed for the semi-quantitative measurement of cocaine metabolites in Each product is intended strictly for in vitro diagnostic use, and each product urine. provides a preliminary analytical test result.
Performance Equivalence - Technological Comparison:
IMMULITE® Cocaine Metabolite is a chemiluminescent immunoassay. The technology in IMMULITE® Cocaine Metabolite is identical to technology used in previously cleared and commercially marketed IMMULITE® products. DPC's Coat-A-Count Cocaine Metabolite is a solid-phase 125 I radioimmunoassay
IMMULITE® Cocaine Metabolite is a solid-phase, chemiluminescent immunometric assay. The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with a monoclonal antibody specific for benzoylecgonine. The patient sample and alkaline phosphatase-conjugated benzoylecgonine are simultaneously introduced into the Test Unit, and incubated for 30 minutes at 37℃ with intermittent agitation. During this time, benzoylecgonine in the sample competes with the enzyme-labeled benzoylecgonine 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.
Image /page/1/Picture/7 description: The image shows a logo with the text "EXCELLENCE in DIAGNOSTICS" arranged in an arc at the top right. A globe is in the background, and the number "25" is prominently displayed in the foreground. The word "YEARS" is at the bottom of the logo.
The chemiluminescent substrate, PPD (a phosphate ester of adamantyl dioxetane), undergoes hydrolysis in the presence of alkaline phosphatase to yield 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 benzoylecgonine in the sample.
DPC's Coat-A-Count® Cocaine Metabolite is a solid-phase radioimmunoassay wherein 1271-labeled benzoylecgonine competes for a fixed time with benzoylecgonine in the patient sample for sites on benzoylecgonine-specific antibody. The antibody being immobilized to the wall of a polypropylene tube, decanting the supernatant suffices to terminate the competition and to isolate the antibody-bound fraction of the radiolabeled benzoylecgonine. Counting the tube in a gamma counter than yields a number, which converts by way of a calibration curve to a measure of the benzoylecgonine present in the patient sample.
Performance Equivalence - Method Comparison
IMMULITE® Cocaine Metabolite procedure was compared to Coat-A-Count Cocaine Metabolite on a total of 351 urine samples obtained from a drug testing laboratory, with the following results:
2
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597 Tel: (213) 776-0180 Fax: (213) 776-0204
Performance Equivalence - Method Comparison (continued):
| CAC | Positive | Negative | ||
|---|---|---|---|---|
| Positive | 229 | 11 | ||
| Negative | 5 | 106 |
223 of the 234 specimens tested positive by the IMMULITE Cocaine Metabolite procedure were tested by the GC/MS procedure. 221 of the 223 IMMULITE positive specimens were found positive by the GC/MS procedure (cutoff 150 ng/mL), achieving a confirmation rate of 99% (221/223).
Interpretation of Results
Using a cutoff of 300 ng/mL (0.3 ug/mL), as recommended in the SAMHSA guidelines, a numerical result greater than or equal to 300 ng/mL is interpreted as positive for cocaine metabolite, whereas a result less than 300 ng/mL is interpreted as negative.
Image /page/2/Picture/6 description: The image shows a logo with the text "EXCELLENCE in DIAGNOSTICS" arranged in a circular fashion around a globe. The number "29" is prominently displayed on the left side of the globe, with the word "YEARS" written below it. The logo appears to be for a company or organization that has been in the diagnostics field for 29 years.
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 Hevia
9/16/56
Edward M. Levine, Ph.D. Director of Clinical Affairs
Date