The COC Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose.

The COC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Description

The Dade Behring Dimension® COC method is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge (Flex®) for use on the Dade Behring Dimension® clinical chemistry system.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension® Urine Cocaine Metabolite Screen (COC) Flex® reagent cartridge:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (COC Flex® vs. Predicate)	Reported Device Performance (COC Flex® vs. GC/MS)
Correct identification of positive samples (relative to predicate)	69 true positives	66 true positives
Correct identification of negative samples (relative to predicate)	52 true negatives	51 true negatives
Minimize false positives (relative to predicate)	2 false positives	5 false positives
Minimize false negatives (relative to predicate)	2 false negatives	3 false negatives
"Near-cutoff samples" performance	All discrepant results were within +/- 25% of the cutoff when compared to GC/MS.	All discrepant results were within +/- 25% of the cutoff when compared to GC/MS.

Note: The document does not explicitly state quantitative acceptance criteria (e.g., "sensitivity must be >95%"). Instead, it presents the results of method comparison studies against a predicate device and a reference method (GC/MS). The implied acceptance criteria are that the device performs comparably to the predicate and is reasonably accurate when compared to GC/MS, especially around the cutoff.

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

Test Set Size (vs. Predicate):
- Positive: 69 + 2 = 71
- Negative: 2 + 52 = 54
- Total: 125 samples
Test Set Size (vs. GC/MS):
- Positive: 66 + 3 = 69
- Negative: 5 + 51 = 56
- Total: 125 samples
Data Provenance: Not explicitly stated. The document indicates it's a 510(k) submission, typically implying data is gathered from laboratory studies. It does not specify country of origin or whether it's retrospective or prospective.

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

Not applicable. This device is an in vitro diagnostic (IVD) based on chemical analysis, not interpretation by human experts. The ground truth is established by chemical reference methods.

4. Adjudication Method for the Test Set

Not applicable. Human adjudication is not relevant for this type of IVD device. The comparison is made against a reference method (GC/MS) or a predicate device. Discrepancies are usually investigated by re-testing or confirmation with the higher-order reference method. The document notes that discrepant specimens were further analyzed by GC/MS.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is an in vitro diagnostic device for chemical analysis of urine samples. MRMC studies are typically used for medical imaging devices where human readers interpret results.

6. Standalone Performance

Yes. The data presented directly reflects the "standalone" performance of the Dimension® Urine Cocaine Metabolite Screen (COC) Flex® reagent cartridge. The method comparison table shows the agreement/disagreement of the device with the predicate (Syva® Emit® II Plus) and with the gold standard (GC/MS). Its performance is evaluated purely on its analytical results without human interpretation in the comparison.

7. Type of Ground Truth Used

Chemical Reference Method (GC/MS): For the critical evaluation of performance, Gas Chromatography/Mass Spectrometry (GC/MS) was used as the confirmatory method for benzoylecgonine levels. This is explicitly stated in the Indications for Use and in the "Discrepant specimens" section. The predicate device (Syva® Emit® II Plus) also served as a comparative reference.

8. Sample Size for the Training Set

Not reported/applicable. This document describes a 510(k) submission for an in vitro diagnostic assay, which is a chemical reagent-based test. These types of assays typically do not involve "training sets" in the machine learning sense. Their performance characteristics are established through analytical validation studies (e.g., linearity, precision, interference, method comparison) using samples with known analyte concentrations or clinical samples characterized by reference methods. The provided document details the method comparison study results, which are performance data, not training data.

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

Not reported/applicable. As mentioned above, a training set as understood in AI/machine learning is not relevant for this device. The development of such chemical assays relies on established analytical chemistry principles and calibrators to define thresholds and ensure accurate measurement.

Summary

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510(k) Summary for the Expansion of the Indications for Use to include a 150 ng/mL cutoff for the Dimension®Urine Cocaine Metabolite Screen (COC) Flex® reagent cartridge

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: _ KO33 713

Analyte: cocaine metabolite

Type of Test: qualitative or quantitative homogeneous enzyme immunoassay

A. Applicant: Dade Behring Inc.

Submitter's Name Andrea M. Tasker Building 500, Mailbox 514 P.O.Box 6101 Newark, DE 19714-6101
Submission Preparation Date November 25, 2003

B. Proprietary and Established Names: Dimension® Urine Cocaine Metabolite Screen Flex® reagent

C. Regulatory Information:

1.Regulation section: 21CFR862.3250, Cocaine and Cocainc Metabolite test system

1. Classification: Class II
1. Product Code: 91 DIO
Toxicology (91) 4. Panel:

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D. Intended Use:

Indications for Use: The COC Flex® reagent cartridge used on the Dimension clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose.
Special conditions for use statements: The COC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

E. Device Description:

F. Substantial Equivalence Inforamtion:

1. Predicate Device: Syva® Emit® II Plus polyclonal Cocaine Metabolite Assay
1. Predicate K Number(s): K031512

Comparision with Predicate: Indications for use, sample type, cutoff concentration, technology and composition of reagents are similar to the predicate device. The change to the device to expand the indications for use to include a 150ng/mL cutoff includes performance claims for the correct identification of near-cutoff samples.

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H. Device Performance Characteristics:

1. Method Comparison (Semi-Quantitative Results)

	Emit® II Plus polyclonal CocaineMetabolite Assay on the SYVA®-30R(Cutoff 150ng/mL)
COC Flex® reagent cartridgeon theDimension® clinical chemistry system(Cutoff 150ng/mL)	+	-
+	69	2
-	2	52

Dimension	Syva 50K	GC/MS (benzoylecgonine)
142	150	151
147	164	164
159	135	123
150	144	156

COC Flex®reagent cartridgeon theDimension®clinical chemistrysystem(Cutoff 150ng/mL)	GC/MS(cutoff 150 ng/mL)
	+	-
+	66	5
-	3	51

Discrepant specimens (ng/mL): All discrepants were within +/- 25% of the cutoff. Dimension® System GC/MS (benzoylecgonine)_______________________________________________________________________________________________________________________________________________________

ension System	GC/MS
160	123
183	123
168	134
151	140
169	140
143	151
143	157
147	164

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 9 2004

Ms. Andrea M. Tasker Senior Specialist Regulatory Affairs and Compliance Dade Behring Inc. P.O. Box 6101 Newark, DE 19714-6101

Re: K033713

Trade/Device Name: Dimension® Urine Cocaine Metabolite Screen (COC) Flex reagent cartridge Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: November 25, 2003 Received: November 26, 2003

Dear Ms. Tasker:

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).

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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, 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.

Jean M. Cooper, MS, DVM.

Yean 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 Statement

Device Name:

Dimension® Urine Cocaine Metabolite Screen (COC) Flex® reagent cartridge

Indications for Use:

See hard copy for signature page.

Andrea M. Tasker Senior Regulatory Affairs and Compliance Specialist November 25, 2003

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR 801.109)

Division Sign-Off

ાર

Over-the-counter Use (Optional format 1-2-96)

Office of In Vitro Diagnostic Device Evaluation and Safety

Evaluation

KD33713

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Regulation Number and Section

§ 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).