(188 days)
Not Found
No
The description details a competitive ELISA assay, which is a standard biochemical method and does not involve AI or ML. The performance studies focus on traditional analytical metrics like sensitivity, specificity, and agreement with a reference method (GC/MS). There is no mention of AI/ML in the device description, intended use, or performance evaluation.
No
The device is an in-vitro diagnostic (IVD) test for detecting amphetamines in oral fluid, intended for screening and preliminary analytical results in clinical and forensic laboratories, not for treating any condition.
Yes
The device provides qualitative screening results for amphetamines in human oral fluid, which is a preliminary analytical test result used for clinical consideration and professional judgment.
No
The device description explicitly states it is a "Microplate Kit" and lists physical reagents included (microtitre plate, enzyme conjugate, wash buffer, etc.), indicating it is a hardware-based assay 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 forensic laboratories" and provides "qualitative screening results for amphetamines 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 or condition.
- Device Description: It describes a "laboratory based test for the detection of amphetamines in human oral fluid."
- Principle of the Test: It uses a "competitive ELISA for the detection of amphetamines in human oral fluid," which is a common in vitro diagnostic technique.
- Reagents: It supplies reagents specifically designed to react with components in the human oral fluid sample.
- Performance Studies: The performance studies evaluate the device's ability to accurately detect amphetamines in human oral fluid samples (sensitivity, specificity, agreement with a reference method).
- Intended User/Care Setting: It's intended for "Clinical and forensic laboratories" and "professional use only," which are typical settings for IVDs.
- Predicate Device: The mention of a predicate device (K992918; Amphetamine-Specific Intercept™ MICRO-PLATE EIA) further confirms its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory purposes for IVDs.
All these factors 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 state, state of health, or disease.
N/A
Intended Use / Indications for Use
The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is intended for use in clinical and forensic laboratories when used in conjunction with the Cozart® RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for amphetamines in human oral fluid at a cutoff concentration of 15ng/ml. This is equal to 45ng/ml in neat 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 (GCMS) is the preferred confirmatory method.
Product codes
DKZ
Device Description
The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is a laboratory based test for the detection of amphetamines in human oral fluid using a cutoff equivalent to 45ng/mL. The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is a competitive ELISA for the detection of amphetamines 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, 2, 15 and 50ng/ml amphetamine 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
professional use only in clinical and forensic laboratories.
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)
Method Comparison: 163 samples were tested, 67 screened positive for amphetamines, of which 62 were confirmed positive by GC/MS. 96 samples screened negative for amphetamines and 94 were confirmed negative by GC/MS. 96% overall agreement as compared to GC/MS.
Precision: The precision obtained for the Cozart® EIA Amphetamines Oral Fluid Microplate Kit produced CVs less than 11%. The total precision for the kit produced CVs less than 13%.
Sensitivity: The sensitivity is 1.2ng/ml.
Specificity: Twenty potentially interfering unrelated substances were tested for cross reactivity and none were found to cross react. Eleven related compounds were tested and 7 showed a level of cross reactivity.
Cutoff Concentration Validation: Testing samples at the cutoff concentration, 50% above and 50% below were carried out to validate the cutoff concentration. The absorbances obtained for the 7.5ng/ml sample were all higher than the 15ng/ml cutoff calibrator. Similarly the absorbances obtained for the 22.5ng/ml sample were all lower than the 15ng/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. No interference was observed.
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 kit must be read within 15 minutes at 450nm.
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 Amphetamines Oral Fluid Microplate Kit must take place within 25 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 1.2ng/mL (limit of detection)
Overall Agreement with GC/MS: 96%
Predicate Device(s)
Amphetamine-Specific Intercept™ MICRO-PLATE EIA, 510(k) no. K992918
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5420 Pressure infusor for an I.V. bag.
(a)
Identification. A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
PREMARKET NOTIFICATION [510(k)] SUMMARY
JUN - 3 2004
| 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
Regulatory Affairs Manager |
| Date | 19th November 2003 |
| Device Name | Cozart® EIA Amphetamines Oral Fluid Microplate Kit |
| Trade Name | Cozart® EIA Amphetamines Oral Fluid Microplate Kit |
| Classification Name | Amphetamine 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
862.3100 Amphetamine test system |
| Establishment Registration No | |
3002336046
Performance Standards
BS EN ISO 9001:2000; EN 46001:1996
Substantial Equivalence
Amphetamine-Specific Intercept™ MICRO-PLATE EIA, 510(k) no. K992918
1
| Parameter | Cozart® EIA Amphetamines Oral Fluid Microplate Kit | Amphetamine-Specific MICRO-PLATE EIA, 510(k) no. K992918 | InterceptTM |
|---|---|---|---|
| Intended Use | Qualitative test for amphetamines in human oral fluid with a 45ng/ml cutoff. | ||
| Recommend confirmation of positive results by GC/MS. | Qualitative test for amphetamines in human oral fluid with a 100ng/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, 2, 15, 50ng/mL | 0, 50, 100, 200ng/mL | |
| Matrix | Human Oral Fluid | Human Oral Fluid | |
| Controls | None supplied but Cozart recommends using external controls. | Unknown | |
| Method Comparison | 163 samples were tested, 67 screened positive for amphetamines, of which 62 were confirmed positive by GC/MS. 96 samples screened negative for amphetamines and 94 were confirmed negative by GC/MS. 96% Agreement as compared to GC/MS. | 89% Agreement as compared to GC/MS | |
| Precision | CV (%) of 2.7-12.4% | CV (%) of 3.5 - 7.9% | |
| Sensitivity | 1.2ng/mL | Unknown | |
| Specificity | 20 potential interferents tested - none cross-reacted. | 47 potential interferents tested - none cross-reacted. |
Introduction
The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is a laboratory based test for the detection of amphetamines in human oral fluid using a cutoff equivalent to 45ng/mL. The device detailed above was compared to Gas Chromatography/Mass Spectrometry (GC/MS).
Cozart® Bioscience Ltd is the manufacturer of the Amphetamine Oral Fluid Kit. We Cozares Bloodience this device from another manufacturer and the device is not marketed under another product name.
Intended Use
The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is intended for use in clinical and forensic laboratories when used in conjunction with the Cozart® RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for amphetamines in human oral fluid at a cutoff concentration of 15ng/ml. This is equal to 45ng/mL in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample.
The remainder of this document will refer to the 15ng/mL cutoff.
2
This assay is for professional use only and provides only a preliminary Clinical consideration and professional judgement must be analytical test result. 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.
Target Population
The target population for the Cozart® EIA Amphetamines Oral Fluid Microplate Kit is clinical and forensic samples.
Where Used
The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is designed for use in clinical and forensic laboratories. For professional use only.
Design
As can be seen from the Principle of the Test section in the pack insert, the Cozart® EIA Amphetamines Oral Fluid Microplate Kit is a competitive ELISA for the detection of amphetamines in human oral fluid.
Materials
The Cozart® EIA Amphetamines Oral Fluid Microplate kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 2, 15 and 50ng/ml amphetamine in oral fluid matrix).
Performance
Method Comparison
The Cozart EIA Amphetamines Oral Fluid Microplate Kit was compared to Gas Chromatography/Mass Spectrometry (GC/MS). All the samples were tested with the Cozart® EIA Amphetamines Oral Fluid Microplate Kit according to the pack insert enclosed.
163 samples were tested through the Cozart® EIA Amphetamines Oral Fluid Microplate Kit, 67 screened positive and 62 were confirmed positive by GC/MS. 96 samples screened negative and 94 were confirmed negative by GC/MS. Of the 163 samples tested 17 were between -50% cutoff and +50% cutoff.
| New Device | GC/MS Negs | GC/MS Negs between
50% Cutoff
and Cutoff | GC/MS
between
+50%
Cutoff and
Cutoff | Total
GC/MS Pos | Percent
Agreement
with GC/MS | |
|------------|------------|------------------------------------------------|--------------------------------------------------|--------------------|------------------------------------|----|
| Pos | 67 | 5 | 0 | 8 | 62 | 93 |
| Neg | 96 | 94 | 9 | 0 | 2 | 98 |
96% overall agreement as compared with GC/MS
3
Precision
The precision obtained for the Cozart® EIA Amphetamines Oral Fluid Microplate Kit produced CVs less than 11%. The total precision for the kit produced CVs less than 13%. The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is a qualitative manual ELISA assay and CVs of less than 10% are acceptable for this assay type.
Sensitivity
The sensitivity of the Cozart® EIA Amphetamines Oral Fluid Microplate Kit is 1.2ng/ml.
Specificity
Twenty potentially interfering unrelated substances were tested for cross reactivity in the Cozart® EIA Amphetamines Oral Fluid Microplate Kit and none were found to cross react. Eleven related compounds were tested and 7 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 7.5ng/ml sample were all higher than the 15ng/ml cutoff calibrator. Similarly the absorbances obtained for the 22.5ng/ml sample were all lower than the 15ng/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® EIA Amphetamines Oral Fluid Microplate 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 Amphetamines Oral Fluid Microplate Kit must be read within 15 minutes at 450nm.
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 Amphetamines Oral Fluid Microplate Kit must take place within 25 minutes.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 3 2004
Dr. Roberto Liddi Regulatory Affairs Manager Cozart Bioscience Ltd. 45 Milton Park Abington, Oxfordshire United Kingdom OX14 4RU
Re: K033743
Trade/Device Name: Cozart® EIA Amphetamines Oral Fluid Microplate Kit Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ. Dated: May 3, 2004 Reccived: May 3, 2004
Dear Dr. Liddi:
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 indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 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 r ou may) ateres provisions of the Act include requirements for annual registration, listing 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 Register.
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 or uny I edelar sthates and 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).
Image /page/4/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized image of an eagle.
5
Page 2
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, rr you stions 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 I ou may 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,
Jean M. Cooper, MS, DVM.
Jean 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 Radiological Health
Enclosure
6
Indications for Use
| 510(k) Number: | K033743 |
|---|---|
| Device Name: | Cozart® EIA Amphetamines Oral Fluid Microplate Kit |
| Indications For Use: | The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is |
| intended for use in clinical and forensic laboratories when | |
| used in conjunction with the Cozart® RapiScan Oral Fluid | |
| collection system. Using this collection system it provides | |
| qualitative screening results for amphetamines in human | |
| oral fluid at a cutoff concentration of 15ng/ml. This is equal | |
| to 45ng/ml in neat 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 (GCMS) is the preferred confirmatory method. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence at CDRH Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Sc
510(k) KOS
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