(169 days)
Not Found
No
The summary describes a standard in vitro diagnostic test using prepackaged reagents and a clinical chemistry system. There is no mention of AI, ML, or any computational analysis beyond basic signal processing for quantitative/semiquantitative determination. The performance studies are standard method comparisons, not indicative of AI/ML training or validation.
No
The device is an in vitro diagnostic test for the qualitative and semiquantitative determination of MDMA in human urine, which provides preliminary analytical test results for diagnosis and treatment of ecstasy use or overdose, but not direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose." Additionally, the "Device Description" section identifies the device as an "in vitro diagnostic device."
No
The device description explicitly states it 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," indicating it is a hardware-based system with reagents, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the device is for an "in vitro diagnostic test" and is "intended for the qualitative and semiquantitative determination of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine." It also mentions that the measurements are "used in the diagnosis and treatment of ecstasy use or overdose." These phrases clearly indicate a diagnostic purpose performed outside of the body.
- Device Description: The description refers to the device as an "in vitro diagnostic device."
- Anatomical Site: The sample being tested is "human urine," which is a biological sample taken from the body for in vitro analysis.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
DKZ
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.
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
Not Found
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
Method comparison studies were conducted with the EXTC Flex® reagent cartridge on the Dimension® clinical chemistry system vs. a reference method (GC/MS).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison studies were conducted with the EXTC Flex® reagent cartridge on the Dimension® clinical chemistry system vs. a reference method (GC/MS).
Comparison to GC/MS at the 300 ng/mL cutoff:
Positive: EXTC Flex® reagent cartridge on the Dimension® clinical chemistry system Positive (73), Negative (0)
Negative: EXTC Flex® reagent cartridge on the Dimension® clinical chemistry system Positive (11), Negative (54)
% agreement = 92%
Comparison to GC/MS at the 500 ng/mL cutoff:
Positive: EXTC Flex® reagent cartridge on the Dimension® clinical chemistry system Positive (58), Negative (0)
Negative: EXTC Flex® reagent cartridge on the Dimension® clinical chemistry system Positive (11), Negative (56)
% agreement = 91.2%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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:
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
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.
a conc
1
Dade Behring Inc. Date Deming int.
5. Device Intended 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 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.
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 cartridge | |||
| on the Dimension® clinical | |||
| chemistry system | Positive | 73 | 0 |
| Negative | 11 | 54 |
% agreement = 92%
2
Comparison to GC/MS at the 500 ng/mL cutoff
| Reference Method GC/MS | |||
|---|---|---|---|
| Positive | Negative | ||
| EXTC Flex® reagent cartridge | |||
| on the Dimension® clinical | |||
| chemistry system | Positive | 58 | 0 |
| Negative | 11 | 56 |
and the same of the second
% agreement = 91.2%
.
.
: -
: : :
:
3
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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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
5
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.
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.
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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