(219 days)
No
The device description and performance studies describe a standard lateral flow immunoassay, which is a chemical-based test and does not involve AI or ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
This device is a diagnostic test for the detection of drugs of abuse, not a device used to provide therapy or treatment.
Yes
This device is a lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine, providing preliminary qualitative test results for drugs of abuse. This aligns with the definition of a diagnostic device, which is used to identify or detect a disease, condition, or substance.
No
The device description clearly states it is a "lateral flow immunoassay," which is a physical test strip, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "simultaneous detection of multiple drug analytes in urine." Urine is a biological specimen, and the test is performed in vitro (outside the body).
- Device Description: It's described as a "lateral flow immunoassay for the detection of drugs of abuse." Immunoassays are common methods used in IVD tests to detect specific substances in biological samples.
- Performance Studies: The document describes performance studies using "control urines" and "specimens," further indicating the use of biological samples.
- Predicate Devices: The listed predicate devices (K012159 and K002447) are also described as "Rapid Drug Screen" devices, which are typically IVDs used for drug testing.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to help detect infections, diagnose a medical condition, prevent disease, or monitor drug therapies. This device clearly fits that description.
N/A
Intended Use / Indications for Use
"STARTOX" Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. "STARTOX" is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:
Compound: Methamphetamine ((+/-)methamphetamine HCl), Abbreviation: METH, Level: 1000 ng/ml
Compound: Opiates (morphine), Abbreviation: OPI, Level: 300 ng/ml
Compound: Cocaine (benzoylecgonine), Abbreviation: COC, Level: 300 ng/ml
Compound: Cannabinoids (11-nor-Δ9-THC-9-carboxylic-acid), Abbreviation: THC, Level: 50 ng/ml
STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.
Product codes (comma separated list FDA assigned to the subject device)
DJC, DJG, DJG, LDJ
Device Description
A lateral flow immunoassay for the detection of drugs of abuse.
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
For 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)
STARTOX™ drugs of abuse screening test detects 4 drugs in human urine at the levels indicated.
Product performance for Opiates, Cocaine and Cannabinoids was compared Medtox Profile II manufactured by Medtox Diagnostics.
Performance of Methamphetamine was compared to RDS 9 manufactured by American BioMedica, Inc.
Ninety (90) samples were tested against each drug, 50 negative and 40 positive specimens.
Drug status of these samples was tested by EMIT and quantified by GC/MS.
The STARTOX™ Drugs of Abuse Screening Test was compared to a FDA substantially equivalent approved device.
STARTOX™ performed substantially equivalent to the legally marketed device.
Reproducibility was evaluated using control urines containing drug concentrations above and below the stated cut-off. Negative controls were also tested. The results confirmed the reproducibility of the STARTOX™ Drugs of Abuse Screening Test.
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.
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
FEB 2 7 2003
510 (K) SUMMARY
Date of Summary: 2-17-03
Product Name:
STARTOX (4)
Sponsor:
Starplex Scientific, Inc. 50 Steinway Blvd. Etobicoke, Ontario, Canada M9W 6Y3
Correspondent:
Fran White MDC Associates 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Devices:
Product: Rapid Drug Screen - 9 panel Manufactured by: American BioMedica Corp K Number: K012159
PRODUCT DESCRIPTION:
A lateral flow immunoassay for the detection of drugs of abuse.
1
INTENDED USE:
"STARTOX" Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. "STARTOX" is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:
| Compound | Abbreviation | Level |
|---|---|---|
| Methamphetamine ((+/-)methamphetamine HCl) | METH | 1000 ng/ml |
| Opiates (morphine) | OPI | 300 ng/ml |
| Cocaine (benzoylecgonine) | COC | 300 ng/ml |
| Cannabinoids | ||
| (11-nor-Δ9-THC-9-carboxylic-acid) | THC | 50 ng/ml |
STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.
PERFORMANCE CHARACTERISTICS:
STARTOX™ drugs of abuse screening test detects 4 drugs in human urine at the levels indicated.
STARTOX™ is substantial equivalent to Rapid Drug Screen 9 panel manufactured by American BioMedica Corporation 510k number K002447.
Product performance for Opiates, Cocaine and Cannabinoids was compared Medtox Profile II manufactured by Medtox Diagnostics. Performance of Methamphetamine was compared to RDS 9 manufactured by American BioMedica, Inc. Ninety (90) samples were tested against each drug, 50 negative and 40 positive specimens. Drug status of these samples was tested by EMIT and quantified by GC/MS.
The STARTOX™ Drugs of Abuse Screening Test was compared to a FDA substantially equivalent approved device. STARTOX™ performed substantially equivalent to the legally marketed device.
Reproducibility was evaluated using control urines containing drug concentrations above and below the stated cut-off. Negative controls were also tested. The results confirmed the reproducibility of the STARTOX™ Drugs of Abuse Screening Test.
2
CONCLUSION:
STARTOX™ Drug of Abuse Screening Test is substantially equivalent to ABMC Rapid Drug Screen multi-drug products (K012159, K002447) previously cleared for market as demonstrated by the results obtained in the studies.
3
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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 7 2003
Starplex Scientific, Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915
Re: K022388
Trade/Device Name: Startox Drug of Abuse Screening Test Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: DJC; DJG; DJG; LDJ Dated: December 4, 2002 Received: December 6, 2002
Dear Ms. White:
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).
4
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
5
510(K) NUMBER: K022388
Device Name: STARTOX Drug of Abuse Screening Test
Indication for Use:
"STARTOX" Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. "STARTOX" is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:
| Compound | Abbreviation | Level |
|---|---|---|
| Methamphetamine ((+/-)methamphetamine HCl) | METH | 1000 ng/ml |
| Opiates (morphine) | OPIATES | 300 ng/ml |
| Cocaine (benzoylecgonine) | COCAINE | 300 ng/ml |
| Cannabinoids | ||
| (11-nor-Δ9-THC-9-carboxylic-acid) | THC | 50 ng/ml |
STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.
For professional use only.
Cooger
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022388
(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) |
OROver The Counter Use (Optional Format 1-2-96)