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.

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 device detailed above was compared to Gas Chromatography/Mass Spectrometry (GC/MS).

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.

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).

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study data, as requested:

Acceptance Criteria and Device Performance Study for Cozart® EIA Amphetamines Oral Fluid Microplate Kit

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct thresholds in the provided document. Instead, the document presents comparison data against a "gold standard" (GC/MS) and a predicate device. Based on the performance reported, an implicit acceptance criterion can be inferred as achieving a high agreement with GC/MS. The precision (CV%) is explicitly stated as acceptable if below 10%.

Parameter	Acceptance Criteria (Inferred/Explicit)	Reported Device Performance (Cozart® EIA Amphetamines Oral Fluid Microplate Kit)
Overall Agreement with GC/MS	High agreement with GC/MS (e.g., comparable to or better than predicate)	96%
Precision (CV%)	< 10% (for qualitative manual ELISA assay)	2.7-12.4% (total precision <13%) for the kit; <11% for precision study
Sensitivity	Sufficiently low to detect amphetamines at specified cutoff (45ng/ml or 15ng/ml diluted)	1.2 ng/mL
Specificity (Cross-reactivity)	No cross-reactivity with common interferents; well-defined cross-reactivity with related compounds	20 potential interferents tested - none cross-reacted. 7 of 11 related compounds showed cross-reactivity.
Cutoff Concentration Validation	Samples at -50% and +50% of cutoff are correctly classified.	7.5ng/ml absorbances higher than 15ng/ml calibrator; 22.5ng/ml absorbances lower than 15ng/ml calibrator.
Interference	No interference from common oral fluid components/ingestions.	No interference observed from various parameters (alcohol, smoking, coffee, food, etc.).
Stopped Assay Stability	Absorbance readable within a specific timeframe.	Must be read within 15 minutes at 450nm.
Assay Drift	Limited change in results across sample addition times.	Sample addition must take place within 25 minutes.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 163 samples.
Data Provenance: Not explicitly stated regarding country of origin or whether the data was retrospective or prospective. However, the context suggests these were human oral fluid samples collected for "clinical and forensic samples" for the purpose of this study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method, not human expert consensus for this type of test.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth was established by GC/MS, an objective chemical analysis method, not by human experts requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an immunoassay (ELISA) for detecting amphetamines. It is a laboratory-based automated or semi-automated test, not a medical imaging or diagnostic device requiring human reader interpretation, nor does it involve AI assistance in the context of human reader improvement.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance study describes the standalone performance of the Cozart® EIA Amphetamines Oral Fluid Microplate Kit. The device (kit) was tested independently, and its results were compared directly against GC/MS. There is no human-in-the-loop component mentioned that would alter the device's output.

7. The Type of Ground Truth Used

The ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method." and "The Cozart® EIA Amphetamines Oral Fluid Microplate Kit was compared to Gas Chromatography/Mass Spectrometry (GC/MS)."

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" or its size. The 163 samples described were used for the performance comparison study, which assesses the device's accuracy against the ground truth. As this is an immunoassay kit, not a machine learning algorithm that typically requires a large training set, the concept of a training set in this context is less relevant in the same way it would be for AI/ML device submissions. The kit would have been developed and optimized through internal R&D, but specific training set data is not typically disclosed in 510(k) summaries for such devices.

9. How the Ground Truth for the Training Set Was Established

As no "training set" is explicitly mentioned for the reported comparison study (see #8), this question is not directly applicable. If a training set were implied for the kit's development, its ground truth would also presumably be established by highly accurate confirmatory methods like GC/MS.

Summary

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PREMARKET NOTIFICATION [510(k)] SUMMARY

JUN - 3 2004

Submitter	Cozart® Bioscience Ltd45 Milton ParkAbingdonOxfordshire OX14 4RUUKTel No: 01235 861483Fax No: 01235 835607
Contact Person	Dr Roberto LiddiRegulatory 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 IICode of Federal Regulations Title 21 Food and DrugsPart 862 Clinical Chemistry and Clinical Toxicology DevicesSubpart D Clinical Toxicology Test Systems862.3100 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

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Parameter	Cozart® EIA Amphetamines Oral Fluid Microplate Kit	Amphetamine-Specific MICRO-PLATE EIA, 510(k) no. K992918
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

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.

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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

Materials

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 between50% Cutoffand Cutoff	GC/MSbetween+50%Cutoff andCutoff	TotalGC/MS Pos	PercentAgreementwith GC/MS
Pos	67	5	0	8	62	93
Neg	96	94	9	0	2	98

96% overall agreement as compared with GC/MS

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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.

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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.

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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

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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 isintended for use in clinical and forensic laboratories whenused in conjunction with the Cozart® RapiScan Oral Fluidcollection system. Using this collection system it providesqualitative screening results for amphetamines in humanoral fluid at a cutoff concentration of 15ng/ml. This is equalto 45ng/ml in neat oral fluid as the collection system involvesa 1:3 dilution of the sample.
	This assay is for professional use only and provides only apreliminary analytical test result. Clinical consideration andprofessional judgement must be applied to any drug of abuse testresult, particularly in evaluating a preliminary positive result. Inorder to obtain a more confirmed analytical result a more specificalternative chemical method is needed. Gas Chromatography/MassSpectrometry (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

Page 1 of 1___________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.