(335 days)
Not Found
No
The device is a competitive ELISA kit, which is a standard laboratory assay technology and does not involve AI/ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
A therapeutic device is used for treating diseases or conditions. This device is an in-vitro diagnostic test kit used for detecting cotinine in urine, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the kit "acts as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine," which implies a step in diagnosing exposure to nicotine. It also provides "qualitative screening results" for Cotinine, which contribute to a diagnostic assessment.
No
The device is a laboratory-based test kit containing chemical reagents and a microtitre plate, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "laboratory based testing in clinical and analytical laboratories and for insurance assessment." It provides "qualitative screening results for Cotinine in human urine." This clearly indicates it's used to test samples taken from the human body (in vitro) to provide information about a person's health status or exposure (diagnostic aid).
- Device Description: It describes a "competitive ELISA for the detection of Cotinine in human urine." ELISA (Enzyme-Linked Immunosorbent Assay) is a common in vitro diagnostic technique.
- Performance Studies: The document details performance studies like method comparison with GC/MS, precision, sensitivity, specificity, and interference studies, which are standard for evaluating the performance of IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K972481; Auto-Lyte Cotinine EIA) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cozart Bioscience EIA Cotinine Urine Kit is intended for laboratory based testing in clinical and analytical laboratories and for insurance assessment. It provides qualitative screening results for Cotinine in human urine at a cut-off concentration of 500ng/ml. The Cozart EIA Cotinine Urine Kit acts as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine.
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
MKU
Device Description
The Cozart EIA Cotinine Urine Kit is a laboratory based test for the detection of Cotinine in human urine using a cutoff of 500ng/mL. As can be seen from the Principle of the Test section in the pack insert, the Cozart EIA Cotinine Urine Kit test is a competitive ELISA for the detection of Cotinine in human urine. 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, 50, 500 and 5000ng/ml Cotinine in human urine).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory based testing in clinical and analytical laboratories and for insurance assessment. To be used by trained laboratory personnel 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
Description of the test set: 95 urine specimens.
Sample size: 95 samples.
Data source: Samples were collected from drug dependency units in Coventry and Warwick, UK.
Annotation protocol: The Cozart EIA Cotinine Urine Kit was compared to Gas Chromatography/Mass Spectrometry (GC/MS). All the samples were tested with the Cozart EIA Cotinine Urine Kit according to the pack insert enclosed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
Study Type: Method Comparison Study
Sample Size: 95 urine specimens.
Key Results: 57 samples screened positive with Cozart EIA Cotinine Urine Kit and 56 were confirmed positive by GC/MS. 38 samples screened negative with Cozart EIA Cotinine Urine Kit and all 38 were confirmed negative by GC/MS. The percent agreement with GC/MS for positive results was 98% and for negative results was 100%.
Precision:
Study Type: Precision Study
Key Results: The precision obtained for the Cozart EIA Cotinine Urine Kit produced CVs less than 10%. The total precision produced CVs less than 11%. CVs of less than 10% are acceptable for this assay type (qualitative manual ELISA).
Sensitivity:
Study Type: Sensitivity Testing
Key Results: The sensitivity of the Cozart EIA Cotinine Urine Kit is 1.2ng/ml.
Specificity:
Study Type: Specificity Testing (Cross-reactivity)
Key Results: Twenty-eight potentially interfering substances were tested. Only nicotine was found to cross-react at 10,000ng/mL.
Cutoff Concentration Validation:
Study Type: Cutoff Concentration Validation
Key Results: The absorbances for the 375ng/mL sample were all higher than the 500ng/mL cutoff calibrator. The absorbances obtained for the 625ng/ml sample were all lower than the 500ng/ml cutoff calibrator.
Interference Studies:
Study Type: Interference Studies
Key Results: A range of parameters including pH, specific gravity, ascorbic acid and protein were tested. No interference was observed with any of the parameters.
Sample Stability:
Study Type: Sample Stability Testing
Key Results: Urine samples are stable for 21 days stored at 2-8°C, 25°C and 37°C when tested in the Cozart EIA Cotinine Urine Kit. For longer storage, urine samples must be stored frozen (-20°C).
Stopped Assay Stability:
Study Type: Stopped Assay Stability
Key Results: The Cozart EIA Cotinine Urine Kit must be read within 15 minutes at 450nm.
Assay Drift:
Study Type: Assay Drift
Key Results: Sample addition to a Cozart EIA Cotinine Urine Kit must take place within 25 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 1.2ng/ml
Precision: CV (%) of 2-11%
Specificity: Twenty-Eight potential interferents tested - none cross-reacted (excluding nicotine at very high concentrations).
Percent Agreement with GC/MS for positive results: 98%
Percent Agreement with GC/MS for negative results: 100%
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.
Not Found
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).
Not Found
§ 862.3220 Carbon monoxide test system.
(a)
Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.(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 the limitations in § 862.9.
0
MAY 1 4 2003
PREMARKET NOTIFICATION [510(k)] SUMMARY
- 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 6th December 2002
Device Name
Trade Name: Classification Name: Cozart EIA Cotinine Urine Kit Cotinine Test System
Classification
Class I Code of Federal Regulations Title 21 Food and Drugs Part 862 Clinical Chemistry and Clinical Toxicology Devices Subpart D Clinical Toxicology Test Systems Section 862.3220 Cotinine Test System
Establishment Registration No
3002336046
Performance Standards
BS EN ISO 9001:1994; EN 46001:1996
Substantial Equivalence
The Cozart EIA Cotinine Urine Kit is substantially equivalent to the Auto-Lyte Cotinine EIA (K972481) manufactured by Orasure Technologies, Inc.
See below for table of comparison for substantial equivalence.
1
| Parameter | Cozart Cotinine Urine EIA | Auto-Lyte Cotinine EIA |
|---|---|---|
| Intended Use | Qualitative test for Cotinine in | |
| human urine with a 500ng/ml | ||
| cutoff. Recommend | ||
| confirmation of positive results | ||
| by GC/MS. | Qualitative and Semi- | |
| quantitative test for Cotinine in | ||
| human urine with a 500ng/ml | ||
| cutoff. Recommend | ||
| confirmation of positive results | ||
| by GC/MS. | ||
| Target Population | Clinical and forensic samples | |
| and insurance assessment. | Insurance risk assessment. | |
| Design | Competitive ELISA | Competitive EIA for use on |
| clinical chemistry analysers. | ||
| Enzyme | Horse Radish Peroxidase | Glucose-6-phosphate |
| dehydrogenase. | ||
| Substrate | Tetramethylbenzidine (TMB) | Glucose-6-phosphate |
| Results | Read spectrophotometrically at | |
| 450nm. | Measure production of NADH | |
| spectrophotometrically at 340nm. | ||
| Calibrators | 0, 100, 300 and 1000ng/ml. | 0, 500 and 5000ng/ml. |
| Controls | None supplied but Cozart | |
| recommends using external | ||
| controls. | None supplied. | |
| Method | ||
| Comparison | 95 Urine Specimens were tested, | |
| 57 screened positive of which 56 | ||
| were confirmed by GC/MS. 38 | ||
| samples screened negative and | ||
| all 38 were confirmed negative | ||
| by GC/MS. | 218 Urine specimens were tested, | |
| 160 from self reported smokers, | ||
| and 58 from non-smokers. All | ||
| samples were confirmed by | ||
| GC/MS | ||
| Precision | CV (%) of 2-11% | Precision of less than 2%. |
| Sensitivity | 1.2ng/ml | Unknown |
| Specificity | Twenty-Eight potential | |
| interferents tested - none cross- | ||
| reacted. | 48 potential interferents tested - | |
| none cross-reacted. |
Introduction
The Cozart EIA Cotinine Urine Kit is a laboratory based test for the detection of Cotinine in human urine using a cutoff of 500ng/mL. The device detailed above was compared to Gas Chromatography/Mass Spectrometry (GC/MS).
Cozart Bioscience Ltd is the manufacturer of the Cotinine Urine Kit. We have not purchased this device from another manufacturer and the device is not marketed under another product name.
2
Intended Use
The Cozart Bioscience EIA Cotinine Urine Kit is intended for laboratory based testing in clinical and forensic laboratories and for insurance assessment. It provides qualitative screening results for Cotinine in human urine at a cutoff concentration of 500ng/mL. The Cozart EIA Cotinine Urine Kit acts as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine.
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 Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred is needed. confirmatory method.
Target Population
The target population for the Cozart EIA Cotinine Urine Kit is clinical and forensic samples.
Where Used
The Cozart EIA Cotinine Urine Kit is designed for use in clinical and forensic laboratories and for insurance risk assessment. To be used by trained laboratory personnel only.
Design
As can be seen from the Principle of the Test section in the pack insert, the Cozart EIA Cotinine Urine Kit test is a competitive ELISA for the detection of Cotinine in human urine.
Materials
The Cozart EIA Cotinine Urine kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 50, 500 and 5000ng/ml Cotinine in human urine).
Performance
Method Comparison
The Cozart EIA Cotinine Urine Kit was compared to Gas Chromatography/Mass Spectrometry. All the samples were tested through the Cozart EIA Cotinine Urine Kit according to the pack insert enclosed. Forty-four samples were positive by Cozart Cotinine Microplate EIA and forty-four were confirmed
3
positive by GC/NPD. Of these forty-four samples, three were in the range 625 -500ng/mL (between +25% cutoff and the cutoff).
All the samples were tested with the Cozart EIA Cotinine Urine Kit according to the pack insert enclosed. Ninety-five samples were tested through the Cozart EIA Cotinine Urine Kit, of which 57 screened positive and 56 were confirmed positive by GC/MS subject to cut offs of 500ng/mL. Thirty-eight samples screened negative for cotinine and all 38 were confirmed by GC/MS.
Of the 95 samples tested 9 were in the range 375 - 625g/mL (between -25% cutoff and +25% cutoff).
| New Device | GC/MS Negs | Near Cutoff GC/MS Negs * | Near Cutoff GC/MS Pos ** | GC/MS Pos*** | Percent Agreement with GC/MS | |
|---|---|---|---|---|---|---|
| Pos | 57 | 1 | 0 | 3 | 56 | 98 |
| Neg | 38 | 38 | 6 | 0 | 0 | 100 |
- Between -25% Cutoff and the Cutoff.
** Between +25% Cutoff and the Cutoff.
*** Total number of positives (includes near cutoff samples).
Precision
The precision obtained for the Cozart EIA Cotinine Urine Kit produced CVs less than 10%. The total precision for the Kit produced CVs less than 11%. The Cozart EIA Cotinine Urine 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 Cotinine Urine Kit is 1.2ng/ml.
Specificity
Twenty-eight potentially interfering substances were tested for cross reactivity in the Cozart EIA Cotinine Urine Kit and only nicotine was found to cross react at 10,000ng/mL.
Cutoff Concentration
Testing samples at the cutoff concentration, 25% above and 25% below was carried out to validate the cutoff concentration. The absorbances for the 375ng/mL sample were all higher than the 500ng/mL cutoff calibrator. Similarly the absorbances obtained for the 625ng/ml sample were all lower than the 500ng/ml cutoff calibrator.
4
Interference Studies
A range of parameters including pH, specific gravity, ascorbic acid and protein were tested for potential interference in the Cozart EIA Cotinine Urine Kit. No interference was observed with any of the parameters.
Sample Stability
Sample stability was carried out at 2-8°C, room temperature and 37°C. Each sample was tested on day 0, 4, 7, 14 and 21. Urine samples are stable for 21 days stored at 2-8°C, 25°C and 37°C when tested in the Cozart EIA Cotinine Urine Kit. For longer storage urine samples must be stored frozen (-20℃).
Stopped Assay Stability
The stability of the stopped assay was investigated by reading the absorbance at 450nm at time 0, 5, 10, 15, 30, 45 and 60 minutes. The Cozart EIA Cotinine Urine 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 Cotinine Urine Kit must take place within 25 minutes.
5
Method Comparison
The method comparison study was performed at Cozart Bioscience Ltd by Cozart Bioscience staff. The GC/MS was performed by the Analytical Services Laboratory at Cozart Bioscience Ltd.
The samples were collected from drug dependency units in Coventry and Warwick, UK. They were selected for testing due to the assumption that a large proportion of these people would be smokers.
The Cozart EIA Cotinine Urine Kit was compared to Gas Chromatography/Mass Spectrometry (GC/MS). All the samples were tested with the Cozart EIA Cotinine Urine Kit according to the pack insert enclosed. Ninety-five samples were tested through the Cozart EIA Cotinine Urine Kit, of which 57 screened positive and 56 were confirmed positive by GC/MS subject to cut offs of 500ng/mL. Thirty-eight samples screened negative for cotinine and all 38 were confirmed by GC/MS.
Of the 95 samples tested 9 were in the range 375 - 625g/mL (between -25% cutoff and +25% cutoff).
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human profile.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Roberto Liddi Quality Assurance/Regulatory Affairs Manager Cozart Bioscience Limited 45 Milton Park Abingdon Oxfordshire, OX14 4RU United Kingdom
MAY 1 4 2003
Re: K021944
Trade/Device Name: Cozart EIA Cotinine Urine Test Regulation Number: 21 CFR § 862.3220 Regulation Name: Carbon Monoxide Test System Regulatory Class: I Product Code: MKU Dated: April 14, 2003 Received: April 18, 2003
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 general controls 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 comply with all the Act's requirements, 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). 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.
7
Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions 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 Division 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.
steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Page I of
K021944 510(k) Number (if known):
Cozart EIA Cotinine Urine Kit Device Name:_
Indications For Use:
The Cozart Bioscience EIA Cotinine Urine Kit is intended for laboratory based testing in clinical and analytical laboratories and for insurance assessment. It provides qualitative screening results for Cotinine in human urine at a cut-off concentration of 500ng/ml. The Cozart EIA Cotinine Urine Kit acts as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine.
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.
Jan
Copper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021944
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
(Optional Format 3-10-98)
| 510(k) |
|---|
| prescription |
OTC