The EXTC Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semiquantitative determination of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose.

The EXTC 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 Dimension® Urine Ecstasy Screen Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dade Behring Dimension® clinical chemistry system.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Dimension® Urine Ecstasy Screen Flex® Reagent Cartridge

This report summarizes the acceptance criteria and the study proving the Dimension® Urine Ecstasy Screen Flex® reagent cartridge meets these criteria, as detailed in the provided 510(k) Premarket Notification (K053337).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device (Emit® II Plus Ecstasy Assay, K043028) through method comparison studies against a reference method. The primary measure of performance is the percentage agreement with Gas Chromatography/Mass Spectrometry (GC/MS). While explicit numerical acceptance criteria for percent agreement are not stated, the reported values are presented as evidence of acceptable performance for substantial equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance (vs. GC/MS)
Demonstrate substantial equivalence to predicate device
Acceptable performance when compared to reference method GC/MS at 300 ng/mL cutoff	92% agreement (Concordance Table)
Acceptable performance when compared to reference method GC/MS at 500 ng/mL cutoff	91.2% agreement (Concordance Table)

The device performance is reported as the percent agreement between the EXTC Flex® reagent cartridge and the reference method (GC/MS) at both cutoffs.

2. Sample Size and Data Provenance

The sample sizes for the test set can be derived from the concordance tables:

300 ng/mL Cutoff Test Set:
- Positive (GC/MS) samples: 73
- Negative (GC/MS) samples: 54
- Total samples: 73 (positive concordant) + 11 (negative discordant) + 54 (negative concordant) + 0 (positive discordant) = 138 urine samples
500 ng/mL Cutoff Test Set:
- Positive (GC/MS) samples: 58
- Negative (GC/MS) samples: 56
- Total samples: 58 (positive concordant) + 11 (negative discordant) + 56 (negative concordant) + 0 (positive discordant) = 125 urine samples

The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set. Instead, it states that Gas Chromatography/Mass Spectrometry (GC/MS) was used as the reference method to establish the ground truth. GC/MS is a highly sensitive and specific analytical technique considered a definitive method for drug confirmation, acting as the "gold standard" in this context rather than relying on human expert interpretation.

4. Adjudication Method

The document does not describe an adjudication method for the test set. Since the ground truth was established by GC/MS, a highly objective analytical method, a formal adjudication process involving human experts would typically not be required for the primary result.

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

No MRMC comparative effectiveness study was performed or described in the provided document. The device is a diagnostic reagent cartridge for an automated clinical chemistry system, not a device requiring human interpretation of output. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Method comparison studies were conducted with the EXTC Flex® reagent cartridge on the Dimension® clinical chemistry system vs. a reference method (GC/MS)." This directly assessed the algorithm's performance (as embodied by the reagent cartridge and system) without human intervention in the result determination.

7. Type of Ground Truth Used

The type of ground truth used was analytical reference method (Gas Chromatography/Mass Spectrometry - GC/MS). The document explicitly states: "Method comparison studies were conducted with the EXTC Flex® reagent cartridge on the Dimension® clinical chemistry system vs. a reference method (GC/MS)." and "GC/MS is the preferred confirmatory method."

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. The provided information focuses solely on the performance evaluation against a reference method, which serves as the validation or test set.

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

Since the document does not mention a training set or its sample size, it does not describe how the ground truth for any training set was established. This type of 510(k) submission for an in vitro diagnostic (IVD) often focuses on validation rather than AI/machine learning model training.

Summary

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Dade Behring Inc. 510(k) Premarket Notification - Dimension® Urine Ecstasy Screen Flex® reagent cartridge

510(k) Summary EXTC Flex® reagent cartridge

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

The assigned 510(k) number is:

K053337

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation

Manufacturer:

Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

Contact Information:

Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714
Attn: Yuk-Ting Lewis
Tel: 302-631-7626

Date of Preparation:

Nov. 29, 2005

2. Device Name / Classification

Dimension® Urine Ecstasy Screen Flex® reagent cartridge / Amphetamine Test System Classification: Class II (862.3100)

3. Identification of the Predicate Device

Emit® II Plus Ecstasy Assay, K043028

4. Device Description

a conc

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Dade Behring Inc. Date Deming int.

5. Device Intended Use

Medical device to which equivalence is claimed and comparison information Q.

The EXTC Flex® reagent cartridge is substantially equivalent in intended use and methodology to the Emit® II Plus Ecstasy Assay (K043028). Both devices are enzyme immunoassays intended for use in the qualitative and semiquantitative determination of ecstasy drugs in human urine. Both assays have two cutoffs: 300 ng/mL and 500 ng/mL.

Method comparison studies were conducted with the EXTC Flex® reagent cartridge on the Dimension® clinical chemistry system vs. a reference method (GC/MS). Results are summarized in the 2 x 2 concordance tables below.

Comparison to GC/MS at the 300 ng/mL cutoff

	Reference Method GC/MS
	Positive	Negative
EXTC Flex® reagent cartridgeon the Dimension® clinicalchemistry system	Positive	73	0
	Negative	11	54

% agreement = 92%

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Comparison to GC/MS at the 500 ng/mL cutoff

		Reference Method GC/MS
		Positive	Negative
EXTC Flex® reagent cartridgeon the Dimension® clinicalchemistry system	Positive	58	0
	Negative	11	56

and the same of the second

% agreement = 91.2%

: -

: : :

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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 its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Yuk-Ting Lewis Regulatory Affairs & Compliance Manager Dade Behring Inc. PO Box 6101, M/S 514 Newark DE, 19714

MAY 1 9 2006

Re: K053337

Trade/Device Name: Dimension® Urine Ecstasy Screen Flex® reagent cartridge Regulation Number: 21 CFR§862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: May 8. 2006 Received: May 9, 2006

Dear Ms. Lewis:

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. Iisting 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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, Ph.D. 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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Dade Behring Inc. 510(k) Premarket Notification - Dimension® Urine Ecstasy Screen Flex® reagent cartridee

Indications for Use

510(k) Number (if known):

): K053337

Device Name:

Dimension® Urine Ecstasy Screen Flex® reagent cartridge

Indications For Use:

The EXTC 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 methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K053337
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Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).