(59 days)
No
The device description details a rapid chromatographic immunoassay that provides qualitative results based on the presence or absence of colored lines. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The device operates based on chemical reactions and visual interpretation.
No.
The device is a rapid diagnostic test for the qualitative detection of various drugs in human urine; it is not intended for treatment or therapy.
Yes
Explanation: The device is a rapid chromatographic immunoassay intended for the qualitative and simultaneous detection of various substances in human urine, which directly falls under the definition of a diagnostic device. It provides "preliminary analytical test results" to aid in determining the presence of certain drugs.
No
The device description clearly states it is a "rapid chromatographic immunoassay" and a "competitive binding, lateral flow immunochromatographic assay," which are hardware-based test methods. It also mentions "Test Card" and "Integrated Cups," indicating physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "qualitative and simultaneous detection of [various drugs] in human urine". This is a classic description of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a person's health status (presence of drugs).
- Device Description: The description details a "rapid chromatographic immunoassay," which is a common type of IVD technology used for detecting specific substances in biological fluids.
- Anatomical Site: The device analyzes "human urine," which is a biological specimen.
- Intended User / Care Setting: While it's intended for healthcare professionals, this doesn't preclude it from being an IVD. Many IVDs are used by trained professionals in healthcare settings.
- Predicate Devices: The predicate devices listed (K020313 and K023946) are also described as "Multi-drug Multi-line Test Card & Test Device," which are consistent with IVD products.
The fact that it provides a "preliminary analytical test result" and requires confirmation by a more specific method like GC/MS is also typical for many screening IVDs.
N/A
Intended Use / Indications for Use
The ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with three types of Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates. Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethamphetamine in human urine at the cutoff concentrations of:
50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 1,000 ng/mL for Amphetamine, 2,000 or 300 ng/mL for Opiates (OPI2000 or MOP300), 25 ng/mL for Phencyclidine, 300 ng/mL for Benzodiazepine, 300 ng/mL for Methadone, 300 ng/mL for Barbiturate. 1,000 ng/mL for Tricyclic Antidepressants, and 500 ng/mL for Methylenedioxymethamphetamine
These assay systems can only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, especially when preliminary positive results are indicated.
They are only intended for healthcare professionals including professionals at point of care sites.
Product codes
LDJ, DIO, DJC, DKZ, DJG, LCM, JXM, DJR, DIS, LFG
Device Description
The ACON Spectrum Multi-Drug Multi-Line Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Screen Test Card with Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Antidepressants Benzodiazepine. Methadone, Barbiturate, Tricyclic and Methylenedioxymethamphetamine in human urine at the cutoff concentrations of:
50 ng/mL for Marijuana. 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 1,000 ng/mL for Amphetamine, 2,000 or 300 ng/mL for Opiates (OPI2000 or MOP300), 25 ng/mL for Phencyclidine, 300 ng/mL for Benzodiazepine, 300 ng/mL for Methadone, 300 ng/mL for Barbiturate, 1,000 ng/mL for Tricyclic Antidepressants, and 500 ng/mL for Methylenedioxymethamphetamine.
These tests can be performed without the use of an instrument.
A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic -Antidepressants and Methylenedioxymethamphetamine at the concentrations below the designated cut-off levels will generate a colored-line in the designated test region for the drug. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
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
healthcare professionals including professionals at point of care sites.
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
Not Found
Key Metrics
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).
0
AUG - 4 2003
SUMMARY OF 510(k)
This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) number is K031759.
Submitter:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-535-2030 Fax: 858-535-2038
Date:
July 28, 2003
Contact Person:
Edward Tung, Ph.D.
Product Names:
ACON Spectrum Multi-Drug Multi-Line Screen Test Card
ACON Spectrum Multi-Drug Multi-Line Screen Test Card with Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup)
1
Common Name:
Immunochromatographic test for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethamphetamine in human urine.
Device Classification:
Marijuana. Cocaine. Methamphetamine. Amphetamine. Opiates. Phencyclidine, Benzodiazepine. Methadone, Barbiturate. Tricyclic Antidepressants and Methylenedioxymethamphetamine test systems have been classified as Class II devices with moderate complexity.
The ACON One Step Multi-Line Screen Test Card and Test Device are similar to other FDA-cleared devices for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethamphetamine in human urine.
Intended Use:
The ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with three types of Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup, and ACON 009 Cup or E-Z Split Key Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates. Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethamphetamine in human urine.
These assay systems can only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, especially when preliminary positive results are indicated.
They are only intended for healthcare professionals including professionals at point of care sites.
2
Description:
The ACON Spectrum Multi-Drug Multi-Line Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Screen Test Card with Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Antidepressants Benzodiazepine. Methadone, Barbiturate, Tricyclic and Methylenedioxymethamphetamine in human urine at the cutoff concentrations of:
50 ng/mL for Marijuana. 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 1,000 ng/mL for Amphetamine, 2,000 or 300 ng/mL for Opiates (OPI2000 or MOP300), 25 ng/mL for Phencyclidine, 300 ng/mL for Benzodiazepine, 300 ng/mL for Methadone, 300 ng/mL for Barbiturate, 1,000 ng/mL for Tricyclic Antidepressants, and 500 ng/mL for Methylenedioxymethamphetamine.
These tests can be performed without the use of an instrument.
A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic -Antidepressants and Methylenedioxymethamphetamine at the concentrations below the designated cut-off levels will generate a colored-line in the designated test region for the drug. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Unmodified ACON Devices
The ACON® Spectrum Multi-drug Multi-line Drug Screen Test Card (12-in-4) is a "combined" product format of the two previously cleared 6-in-2 ACON One Step Multi-drug Multi-line Drug Test Card. The test Cards in these 6-in-2 formats have up to six DOA tests on one or two Test Strips. These two legally marketed but unmodified devices and their 510(k) numbers under which they were previously cleared are listed in Table 1.
3
| ACON DOA Test | | | K
Number | Product
Code |
|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|-------------|-----------------|
| 1. ACON One Step Multi-drug Multi-line Test Card & Test Device
with drug calibrator and cutoff concentration used for each analyte listed | | | | |
| COCAINE ((Benzoylecgonine) | 300 ng/mL | | K020313 | DIO |
| AMPHETAMINE (Amphetamine) | 1,000 ng/mL | | | DKZ |
| OPIATES (Morphine) | 2,000 ng/mL | | | DIG |
| METHAMPHETAMINE (Methamphetamine) | 1,000 ng/mL | | | LAF |
| MARIJUANA (Δ-11-nor-9-THC-9-COOH) | 50 ng/mL | | | LDJ |
| Phencyclidine (PCP) | 25 ng/mL | | | LCM |
| 2. ACON One Step Multi-drug Multi-line Test Card & Test Device (II)
with drug calibrator and cutoff concentration used for each analyte listed | | | K023946 | |
| TRICYCLIC ANTIDEPRESSANTS (Nortriptyline) | 1,000 ng/mL | | | DJC |
| MDMA (Methylenedioxymethamphetamine) | 500 ng/mL | | | LFG |
| BENZODIAZEPINE (Oxazepam) | 300 ng/mL | | | JXM |
| METHADONE (Methadone) | 300 ng/mL | | | DJR |
| BARBITURATES (Secobarbital) | 300 ng/mL | | | DIS |
| MORPHINE (Morphine) | 300 ng/mL | | | DJG |
Table 1. Unmodified ACON Devices with K Numbers and Product Codes.
:
.
:
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
AUG - 4 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward Tung, Ph.D. Director of Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, CA 92121
Re: K031759
Trade/Device Name: ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ; DIO; DJC; DKZ; DJG; LCM; JXM; DJR; DIS; LFG Dated: July 7, 2003 Received: July 11, 2003
Dear Dr. Tung:
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).
5
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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
INDICATION FOR USE:
510(k) Number: K031759
Device Name: ACON Spectrum Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup)
Indications for Use: The ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with three types of Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous derection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates. Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethampheramine in human urine at the cutoff concentrations of:
50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 1,000 ng/mL for Amphetamine, 2,000 or 300 ng/mL for Opiates (OPI2000 or MOP300), 25 ng/mL for Phencyclidine, 300 ng/mL for Benzodiazepine, 300 ng/mL for Methadone, 300 ng/mL for Barbiturate. 1,000 ng/mL for Tricyclic Antidepressants, and 500 ng/mL for Methylenedioxymethamphetamine
These assay systems can only provide a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, especially when preliminary positive results are indicated.
They are only intended for healthcare professionals including professionals at point of care sites.
(Please do not write below this point)
Concurrence of CDRH, Office of In Vitro Device Evaluation and Safety
| Prescription Use | ✓ | Or | over-the-counter Use ______ |
|---|---|---|---|
| (Per 21 CFR 801.109) |
Division Sign-Off For, Jean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
K 031759