(107 days)
Not Found
No
The device description and performance studies indicate a standard lateral flow immunoassay, with no mention of AI or ML components or methodologies.
No
This device is for qualitative detection of MDMA in urine and provides preliminary analytical results for diagnostic purposes, not for treating or preventing disease.
Yes
Explanation: The device is intended to provide "qualitative rapid detection of methylenedioxymethamphetamine (MDMA)" in human urine. Detection of substances in the body for diagnostic purposes falls under the definition of a diagnostic device.
No
The device description clearly states it is a "one-step lateral flow chromatographic immunoassay" with physical components like a test strip, conjugate pad, and nitrocellulose membrane, indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative rapid detection of methylenedioxymethamphetamine (MDMA, or Ecstasy, XTC) in human urine". This involves testing a sample taken from the human body (urine) to provide information about a physiological state (presence of MDMA).
- Device Description: The description details a "lateral flow chromatographic immunoassay". Immunoassays are a common type of test used in IVD devices to detect specific substances in biological samples.
- Sample Type: The test is performed on "human urine".
- Purpose: The purpose is to detect the presence of a substance (MDMA) in a biological sample, which is a core function of IVD devices.
The fact that it's for "health care professional use only" and provides a "preliminary analytical test result" that requires confirmation by another method (like GC/MS) does not negate its classification as an IVD. Many IVD tests are designed for professional use and serve as screening tools requiring further confirmation.
N/A
Intended Use / Indications for Use
This device is a one-step immunoassay intended to provide qualitative detection of methylenedioxymethamphetamine (MDMA, also Ecstasy, or XTC) in human urine at a cutoff concentration of 500ng/ml. It is for health care professional use only.
This device is a one-step intended to provide qualitative rapid detection of methylenedioxymethamphetamine (MDMA, or Ecstasy, XTC) in human urine at a cut-off concentration of 500ng/ml. It is for health care professional use only.
This test 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. 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)
DJC
Device Description
A one-step lateral flow chromatographic immunoassay. The test strip in the device includes 1) a conjugate pad containing colloidal gold coupled with mouse anti-MDMA antibody; 2) nitrocellulose membrane containing a test line (T line) coated with MEMA-BSA and a control line (C line) coated with Goat anti mouse antibody.
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
health care professional use only.
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)
Accuracy studies: Eighty clinical urine specimens with MDMA GC/MS data was evaluated with the Instant-View™ MDMA (Ecstasy, XTC) Urine Test. The results from the Instant-View™ MDMA (Ecstasy, XTC) Urine Test agreed 100% with the MDMA GC/MS data of the clinical specimens at the level below 75% of the cutoff and above the cutoff. Two (2) discrepancies were observed on the specimens with the MDMA GC/MS data between the cutoff level and the level of 75% cutoff. The overall agreement is 97.5%.
Reproducibility studies: The reproducibility of this device was studied outside of Alfa at three Physician's Office Laboratories (POL) and one reference laboratory. Evaluations were performed by personnel with diverse educational backgrounds and working experiences. The results from the four evaluation sites agreed 97.5%, indicating a high reproducibility of this device.
Specificity studies: Two of the structurally related compounds showed cross reactivity with this device: methylenedioxyampphetamine (MDA) at 2000 ng/ml and methylenedioxyethylamphetamine (MDEA) at 1000 ng/ml. Other structurally related compounds tested did not show cross reactivity or interference with this device at the concentration of 100 µg/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall agreement is 97.5% (accuracy study).
Reproducibility agreement 97.5%.
Cross reactivity: methylenedioxyampphetamine (MDA) at 2000 ng/ml and methylenedioxyethylamphetamine (MDEA) at 1000 ng/ml.
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
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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
NOV 1 3 2002
510(k) Summary of Safety and Effectiveness as Required by 21 CFR 807.92
| Submitter and
manufacture | Name: Alfa Scientific Designs, Inc.
Address: 12330 Stowe Drive
Poway, CA 92064
Contact Person: Naishu Wang, MD, Ph.D.
Telephone: (858) 513-3888 x 308
Fax: (858) 513-8388
E-mail: wnss@alfascientific.com |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Trade Name: Instant-View™ MDMA (Ecstasy, XTC) Urine Test
Common Name: Immunoassay, MDMA Urine Test
Classification: Amphetamine Test System (21 CFR 862.3100)
Class II |
| Date of Summary
Preparation | October 28, 2002 |
| Predicate Device | Microgenics A-Sure™ Ecstasy Drug Screen Test made by
Applied Biotech, Inc. K011133 |
| Device Description | A one-step lateral flow chromatographic immunoassay. The
test strip in the device includes 1) a conjugate pad containing
colloidal gold coupled with mouse anti-MDMA antibody; 2)
nitrocellulose membrane containing a test line (T line) coated
with MEMA-BSA and a control line (C line) coated with Goat
anti mouse antibody. |
| Similarity to the
Predicate Device | • Both are one-step later-flow chromatographic immunoassay.
• Both are used for qualitative detection of MDMA (Ecstasy, XTC) at a cutoff of 500 ng/ml.
• Both are based on the similar mechanism
• Both use a C line as built-in control to indicate that an
appropriate volume of sample is applied and the device
performs properly.
• Both provide a preliminary result and a positive result needs
to be confirmed with a more solid reference method. |
| Intended Use | This device is a one-step immunoassay intended to provide
qualitative detection of methylenedioxymeth-
amphetamine (MDMA, also Ecstasy, or XTC) in human urine
at a cutoff concentration of 500ng/ml. It is for health care
professional use only. |
| Accuracy studies | Eighty clinical urine specimens with MDMA GC/MS data was
evaluated with the Instant-View™ MDMA (Ecstasy, XTC) Urine
Test. The results from the Instant-View™ MDMA (Ecstasy, XTC)
Urine Test agreed 100% with the MDMA GC/MS data of the
clinical specimens at the level below 75% of the cutoff and
above the cutoff. Two (2) discrepancies were observed on the
specimens with the MDMA GC/MS data between the cutoff
level and the level of 75% cutoff.
The overall agreement is 97.5%. |
| Reproducibility
studies | The reproducibility of this device was studied outside of Alfa at
three Physician's Office Laboratories (POL) and one reference
laboratory. Evaluations were performed by personnel with
diverse educational backgrounds and working experiences. The
results from the four evaluation sites agreed 97.5%, indicating
a high reproducibility of this device. |
| Specificity studies | Two of the structurally related compounds showed cross
reactivity with this device: methylenedioxyampphetamine
(MDA) at 2000 ng/ml and methylenedioxyethylamphetamine
(MDEA) at 1000 ng/ml. Other structurally related compounds
tested did not show cross reactivity or interference with this
device at the concentration of 100 µg/ml. |
| Conclusion | The results of accuracy, reproducibility, and specificity studies
demonstrate that the Instant-View™ MDMA (Ecstasy, XTC)
Urine Test is substantially equivalent to the legally marketed
test. |
・
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus with three intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo in a circular fashion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 3 2002
Naishu Wang, M.D., Ph.D. . President Alfa Scientific Designs, Inc. 12330 Stowe Drive Poway, CA 92064
Re: K022501
Trade/Device Name: Instant-View™ MDMA (Ecstasy, XTC) Urine Test Regulation Number: 21 CFR 862.3610 Regulation Name: Methanphetamine test system Regulatory Class: Class II Product Code: DJC Dated: October 28, 2002 Received: October 31, 2002
Dear Dr. Wang:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and i additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510 (K) NUMBER (IF KNOWN) :
DEVICE NAME : Instant-View" MDMA (Ecstasy, XTC) Urine Test
INDICATIONS FOR USE:
This device is a one-step intended to provide qualitative rapid detection of methylenedioxymethamphetamine (MDMA, or Ecstasy, XTC) in human urine at a cut-off concentration of 500ng/ml. It is for health care professional use only.
This test 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. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
(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)
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022501