(95 days)
No
The device description and performance studies describe a standard ELISA-based immunoassay kit for drug screening, which does not involve AI or ML technology. There are no mentions of AI, ML, or related concepts like DNNs or training/test sets for algorithmic models.
No.
The device is an in vitro diagnostic test for screening cocaine and its metabolites, not a device used for therapy.
Yes
The device provides qualitative screening results for cocaine and metabolites in human oral fluid, which is a preliminary analytical test result used for clinical consideration and professional judgment. While it states that a more confirmed result is needed, its primary function is to screen for the presence of certain substances for diagnostic purposes.
No
The device description clearly states it is a "laboratory based test" and lists physical reagents included in the kit, such as a microtitre plate, enzyme conjugate reagent, wash buffer, substrate solution, stop solution, and calibrators. This indicates it is a hardware-based diagnostic kit, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use in clinical and analytical laboratories" and provides "qualitative screening results for cocaine and metabolites in human oral fluid." This clearly indicates it's used to test samples taken from the human body to provide information about a person's health status (in this case, the presence of cocaine).
- Device Description: The description details a "laboratory based test for the detection of cocaine and metabolites in human oral fluid" using a "competitive ELISA." This describes a test performed in vitro (outside the body) on a biological sample (oral fluid).
- Anatomical Site: The test is performed on "Human oral fluid," which is a biological sample taken from the human body.
- Intended User / Care Setting: It's intended for "Clinical and forensic laboratories" and "professional use only," which are typical settings for IVD testing.
- Performance Studies: The document describes performance studies conducted on human samples to evaluate the device's accuracy and reliability in detecting the target substance.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Cozart EIA Cocaine Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for cocaine and metabolites in human oral fluid at a cutoff concentration of 10ng/ml. This is equal to 30ng/ml. in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample.
This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.
Product codes
DIO
Device Description
The Cozart EIA Cocaine Oral Fluid Kit is a laboratory based test for the detection of cocaine and metabolites in human oral fluid using a cutoff equivalent to 30ng/mL. It is a competitive ELISA for the detection of cocaine and its metabolites in human oral fluid. The kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 5, 10 and 50ng/ml benzoylecgonine in oral fluid matrix). Results are read spectrophotometrically at 450nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human oral fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical and forensic laboratories. For professional use only.
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
Method Comparison: The Cozart EIA Cocaine Oral Fluid Kit was compared to Gas Chromatography/Mass Spectrometry (GC/MS). All the samples were tested with the Cozart EIA Cocaine Oral Fluid Kit according to the pack insert enclosed. 177 samples were tested through the Cozart EIA Cocaine Oral Fluid Kit, 100 screened positive and 100 were confirmed positive by GC/MS. 77 samples screened negative and 71 were confirmed negative by GC/MS. Of the 177 samples tested 15 were between -50% cutoff and +50% cutoff. Overall agreement as compared with GC/MS was 96%.
Precision: CVs less than 9% were obtained for the Cozart EIA Cocaine Oral Fluid Kit. The total precision for the kit produced CVs less than 11%. CVs of less than 10% are acceptable for this assay type.
Sensitivity: The sensitivity of the Cozart EIA Cocaine Oral Fluid Kit is 1.8ng/ml.
Specificity: Twenty-nine potentially interfering unrelated substances were tested for cross reactivity in the Cozart Cocaine Oral Fluid Kit and none were found to cross react. Four related compounds were tested and three showed a level of cross reactivity.
Cutoff Concentration: Testing samples at the cutoff concentration, 50% above and 50% below were carried out to validate the cutoff concentration. The absorbances obtained for the 5ng/ml sample were all higher than the 10ng/ml cutoff calibrator. Similarly the absorbances obtained for the 15ng/ml sample were all lower than the 10ng/ml cutoff calibrator.
Interference Studies: A range of parameters including alcohol, sample adequacy indicator dye, haemoglobin, smoking, coffee, tea, water, food, orange juice, hard candy, chewing gum and mouthwash were tested for interference in the Cozart Cocaine Oral Fluid Kit. No interference was observed with any of the parameters.
Stopped Assay Stability: The stability of the stopped assay was investigated by reading the absorbance at 450nm at times 0, 5, 10, 15, 30, 45 and 60 minutes. The Cozart EIA Cocaine Oral Fluid Kit must be read within 15 minutes at 450mm.
Assay Drift: Sample addition at time 0, 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 22.5 and 25 minutes was investigated. Little change was observed across the plate and therefore sample addition to a Cozart EIA Cocaine Oral Fluid Kit must take place within 25 minutes.
Key Metrics
Sensitivity: 1.8ng/mL
Overall Agreement with GC/MS: 96%
Precision (CV): 1.9 – 10.7%
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
PREMARKET NOTIFICATION [510(k)] SUMMARY
APR 2 8 2003
| Submitter | Cozart Bioscience Ltd
45 Milton Park
Abingdon
Oxfordshire OX14 4RU
UK
Tel No: 01235 861483
Fax No: 01235 835607 |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Dr Roberto Liddi
Quality Assurance & Regulatory Affairs Manager |
| Date | 20th January 2003 |
| Device Name | Cozart EIA Cocaine Oral Fluid Kit |
Trade Name Cozart EIA Cocaine Oral Fluid Kit
Classification Name Cocaine Test System
Classification
Class II
Code of Federal Regulations Title 21 Food and Drugs Part 862 Clinical Chemistry and Clinical Toxicology Devices Subpart D Clinical Toxicology Test Systems 862.3250 Cocaine and cocaine metabolite test system
Establishment Registration No
3002336046
Performance Standards
BS EN ISO 9001:1994; EN 46001:1996
Substantial Equivalence
STC Opiates Micro-Plate EIA (Orasure® Application), 510(k) no. K981341
1
| Parameter | Cozart EIA Cocaine Oral Fluid Kit | Cocaine Metabolite Micro-Plate EIA
(Orasure® Application), 510(k) no.
K982061 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Qualitative test for Cocaine in human oral
fluid with a 30ng/ml cutoff. Recommend
confirmation of positive results by GC/MS. | Qualitative test for Cocaine in human oral
fluid with a 10ng/ml cutoff. Recommend
confirmation of positive results by GC/MS. |
| Target Population | Clinical and forensic samples. | Clinical samples. |
| Design | Competitive ELISA | Competitive ELISA |
| Enzyme | Horse Radish Peroxidase | Horse Radish Peroxidase |
| Results | Read spectrophotometrically at 450nm. | Read spectrophotometrically at 450nm. |
| Calibrators | 0, 5, 10, 50ng/mL | 0, 5, 10, 50ng/mL |
| Matrix | Human Oral Fluid | Human Oral Fluid |
| Controls | None supplied but Cozart recommends
using external controls. | Unknown |
| Method Comparison | 177 samples were tested, 100 screened
positive for cocaine and metabolites, of
which 100 were confirmed positive by
GC/MS. 77 samples screened negative for
cocaine and metabolites and 71 were
confirmed negative by GC/MS. | 92% Agreement as compared to GC/MS |
| Precision | CV (%) of 1.9 – 10.7% | CV (%) of 5 – 11.2% |
| Sensitivity | 1.8ng/mL |