(78 days)
Not Found
No
The summary describes a standard in vitro diagnostic test using prepackaged reagents and a clinical chemistry system, with no mention of AI or ML.
No
This device is an in vitro diagnostic device used to determine amphetamines in human urine, which aids in diagnosis. It does not provide any therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states: "Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose."
No
The device description explicitly states it consists of "prepackaged reagents in a plastic cartridge (Flex®)" for use on a clinical chemistry system. This indicates a physical, hardware component (the reagent cartridge) is integral to the device's function.
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 used for the "qualitative and semi-quantitative determination of amphetamines in human urine." It also mentions the results are used in the "diagnosis and treatment of amphetamines use or overdose." These are all hallmarks of an IVD.
- Device Description: The description clearly labels the device as an "in vitro diagnostic device."
- Anatomical Site: The test is performed on "human urine," which is a biological specimen tested outside the body, consistent with an in vitro test.
N/A
Intended Use / Indications for Use
The AMPH 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 amphetamines in human urine using a cutoff of either 300, 500 or 1000ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.
The AMPH 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 (comma separated list FDA assigned to the subject device)
DKZ
Device Description
The Dade Behring Dimension® AMPH 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison (cutoff=300 ng/mL): 129 native urine specimens were tested with the AMPH Flex® cartridge on the Dimension system (cutoff=300 ng/mL ) and with the Syva® Emit® II Plus Amphetamines Assay (9C309UL) on the Syva 30R Biochemical System (cutoff=300 ng/mL ). All 129 specimens were also analyzed by GC/MS. Positives by GC/MS were determined by using the criteria of amphetamine plus methamphetamine > 300 ng/mL since there are no SAMSHA confirmation guidelines for the 300 cutoff. 24 of these had total amphetamines by GC/MS within 25% of the 300 ng/mL cutoff.
Method Comparison (cutoff=500 ng/mL): 129 native urine specimens were tested with the AMPH Flex® cartridge on the Dimension® system (cutoff=500 ng/mL ) and with the Syva® Emit® II Plus Amphetamines Assay (9C309UL) on the Syva 30R® Biochemical System (cutoff=500 ng/mL ). All 129 specimens were also analyzed by GC/MS. Positives by GC/MS were determined using the newly proposed SAMHSA guidelines by following the criteria of ≥ 250 ng/mL methamphetamine and ≥ 100 ng/mL amphetamine or > 250 ng/mL amphetamine regardless of the methamphetamine concentration. 28 of these had total amphetamines by GC/MS within 25% of the 500 ng/mL cutoff.
Method Comparison (cutoff=1000 ng/mL): 169 native urine specimens were tested with the AMPH Flex® cartridge on the Dimension system (cutoff=1000 ng/mL ) and with the Syva® Emit® II Plus Amphetamines Assay (9C309UL) on the Syva 30R® Biochemical System (cutoff=500 ng/mL ). Total amphetamine and methamphetamine values by GC/MS were reported for these 169 specimens. Positives by Confirmation GC/MS were determined according to the SAMHSA requirements by following the criteria of > 500 ng/mL methamphetamine and ≥ 200 ng/mL amphetamine or ≥ 500 ng/mL amphetamine regardless of the methamphetamine concentration. Separate amphetamine and methamphetamine values were available for only 129 of these 169 specimens. Since separate amphetamine and methamphetamine values are required for confirmation testing according to the SAMSHA guidelines, only those 129 samples were represented in the box plot shown in Table 10. Of these 129, there were 9 which had total amphetamines by GC/MS within 25% of the 1000 ng/mL cutoff.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.3100 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).
0
510(k) Summary for the Dimension® Urine Amphetamines/Methamethamine Screen Flex® (DF91B)
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: K040133
Analyte: Amphetamines/Methamethamine
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 January 20, 2004
B. Proprietary and Established Names: Dimension® Urine Amphetamines/Methamethamine Screen Flex® reagent cartridge
C. Regulatory Information:
1.Regulation section: 21CFR §862.3100 Amphetamine test system
-
- Classification: Class II
-
- Product Code: DKZ
-
- Panel: Toxicology (91)
1
D. Intended Use:
-
Indications for Use: The AMPH 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 amphetamines in human urine using a cutoff of either 300, 500 or 1000ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.
-
Special conditions for use statements: The AMPH 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:
The Dade Behring Dimension® AMPH 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.
F. Substantial Equivalence Inforamtion:
-
- Predicate Device: Syva® Emit® II Plus Amphetamine Assay
-
- Predicate K Number(s): K031004
-
- Comparision with Predicate: This product is substantially equivalent to other Amphetamine enzyme immunoassys, such as the Syva® Emit® II Plus Amphetamine Assay (K031004).
2
I. Device Performance Characteristics: Method Comparison (cutoff=300 ng/mL)
129 native urine specimens were tested with the AMPH Flex® cartridge on the Dimension system (cutoff=300 ng/mL ) and with the Syva® Emit® II Plus Amphetamines Assay (9C309UL) on the Syva 30R Biochemical System (cutoff=300 ng/mL ). All 129 specimens were also analyzed by GC/MS. Positives by GC/MS were determined by using the criteria of amphetamine plus methamphetamine > 300 ng/mL since there are no SAMSHA confirmation guidelines for the 300 cutoff. 24 of these had total amphetamines by GC/MS within 25% of the 300 ng/mL cutoff.
Comparison to Predicate Method
Syva 30R® Biochemical System (cutoff 300 ng/mL)
AMPH Flex® Reagent Cartridge on the Dimension® clinical chemistry system (cutoff 300 ng/mL )
| + | - | |
|---|---|---|
| + | 70 | 2 |
| - | 2 | 55 |
Discrepants (ng/mL):
| GC/MS | GC/MS | GC/MS | Dim | Syva |
|---|---|---|---|---|
| Meth | Amph | Total | AMPH | 30R |
| 242 | 61.1 | 303 | 315 | 273 |
| 433 | 250 ng/mL amphetamine regardless of the methamphetamine concentration. 28 of these had total amphetamines by GC/MS within 25% of the 500 ng/mL cutoff. |
Comparison to Predicate Method
Syva 30R® Biochemical System (cutoff 500 ng/mL)
- AMPH Flex® + Reagent Cartridge 43 0 on the Dimension® clinical chemistry system (cutoff 500 1 85 ng/mL )
Discrepants (ng/mL):
| GC/MS | GC/MS | Dim | Syva |
|---|---|---|---|
| Meth | Amph | AMPH | 30R |
| 556 | 62.7 | 405 | 598 |
5
Comparison to Reference Method
GCMS
(cutoff ≥ 250 ng/mL amphetamine
or
≥ 250 ng/mL metamphetamine and
≥ 100 ng/mL amphetamine)
| 0 | ||||
|---|---|---|---|---|
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| 8 ! | ||||
| . |
AMPH Flex® Reagent Cartridge on Dimension® clinical chemistry system (cutoff 500 ng/mL )
Discrepants (ng/mL):
| GC/MS | GC/MS | Dim |
|---|---|---|
| Meth | Amph | AMPH |
| 410 | 36.7 | 550 |
| 506 | 43.6 | 572 |
| 513 | 44.8 | 564 |
| 528 | 47.9 | 572 |
| 561 | 48.6 | 507 |
| 577 | 50.5 | 574 |
| 514 | 56.1 | 534 |
| 495 | 58.4 | 548 |
| 598 | 64.5 | 561 |
| 286 | 169 | 366 |
| 281 | 173 | 388 |
| 254 | 174 | 344 |
| 300 | 179 | 398 |
| 315 | 186 | 393 |
6
Method Comparison (cutoff=1000 ng/mL )
169 native urine specimens were tested with the AMPH Flex® cartridge on the Dimension system (cutoff=1000 ng/mL ) and with the Syva® Emit® II Plus Amphetamines Assay (9C309UL) on the Syva 30R® Biochemical System (cutoff=500 ng/mL ). Total amphetamine and methamphetamine values by GC/MS were reported for these 169 specimens. Positives by Confirmation GC/MS were determined according to the SAMHSA requirements by following the criteria of > 500 ng/mL methamphetamine and ≥ 200 ng/mL amphetamine or ≥ 500 ng/mL amphetamine regardless of the methamphetamine concentration.
Separate amphetamine and methamphetamine values were available for only 129 of thes 169 specimens. Since separate amphetamine and methamphetamine values are required for confirmation testing according to the SAMSHA guidelines, only those 129 samples were represented in the box plot shown in Table 10. Of these 129, there were 9 which had total amphetamines by GC/MS within 25% of the 1000 ng/mL cutoff.
Comparison to Predicate Method
Syva 30R® Biochemical System (cutoff 1000 ng/mL)
| + | ||
|---|---|---|
| AMPH Flex® | ||
| Reagent Cartridge | ||
| on the Dimension® | 62 | 0 |
| clinical chemistry | ||
| system (cutoff 1000 | ||
| ng/mL ) | 102 |
Discrepants (ng/mL):
| GC/MS | GC/MS | Dim | Syva |
|---|---|---|---|
| Meth | Amph | AMPH | 30R |
| 713 | 534 | 929 | 1134 |
| 494 | 844 | 922 | aar |
aar: above assay range, > 2000 ng/mL
7
Comparison to Reference Method
GC/MS
(cutoff ≥ 500 ng/mL amphetamine
or
≥ 500 ng/mL metamphetamine and ≥ 200 ng/mL amphetamine)
AMPH Flex® Reagent Cartridge on Dimension® clinical chemistry system (cutoff 1000 ng/mL )
| - | ||
|---|---|---|
| article of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the | ||
| of Catal | ||
| on the 1 an | ||
| 16 | ||
| + | ||
| of a wound the figure the most the country of the first a | ||
| 8 | ||
| SALE - LENGION LAND | 00 |
Discrepants (ng/mL):
| GC/MS | GC/MS | Dim |
|---|---|---|
| Meth | Amph | AMPH |
| 1223 | 118 | 1264 |
| 1209 | 127 | 1347 |
| 1112 | 172 | 1395 |
| 1183 | 174 | 1314 |
| 1213 | 177 | 1414 |
| 1194 | 180 | 1367 |
| 631 | 202 | 627 |
| 652 | 214 | 375 |
| 713 | 534 | 929 |
| 496 | 615 | 682 |
| 390 | 624 | 681 |
| 333 | 635 | 648 |
| 494 | 844 | 922 |
| 161 | 1032 | 770 |
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, with three stylized lines representing its wings or body.
Public Health Service
APR - 8 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Andrea M. Tasker Senior Regulatory Affairs and Compliance Manger Dade Behring, Inc Chemistry/ Immunochemistry Glasgow Business Community; BLDG. 500 PO Box 6101 Newark, DE 19714
Re: K040133
Trade/Device Name: Dimension® Urine Amphetamine/ Methamphetamine Screen Flex® reagent cartridge (DF91B) Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: DKZ Dated: January 20, 2004 Received: January 21, 2004
Dear Ms. Tasker :
We have reviewed vour 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 enclosurc) 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 complics 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 (OS) regulation (21 CFR Part 820).
9
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
10
Indications For Use Statement
Device Name:
Dimension@ Urine Amphetamine/Methamphetamine Screen Flex® reagent cartridge (DF91B)
Indications for Use:
The AMPH Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in virro diagnostic test intended for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300, 500 or 1000ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.
The AMPH 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.
Jm. T
Andrea M. Tasker Regulatory Affairs and Compliance Manager
January 20, 2004
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-counter Use (Optional format 1-2-96)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
stnka K040133
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