(74 days)
Not Found
No
The device description and performance studies describe a standard lateral flow immunoassay, which is a chemical test and does not involve AI or ML. There are no mentions of AI, ML, or image processing in the provided text.
No
The device is an in vitro diagnostic test used for screening drugs of abuse in urine; it does not provide any therapy or treatment.
Yes
Explanation: The device is a screening test for drug analytes in urine, indicating an intention to detect specific substances to aid in diagnosis or assessment of drug use. The "Intended Use/Indications for Use" section explicitly states its purpose for "simultaneous detection of multiple drug analytes in urine" for "qualitative detection of drugs of abuse," which aligns with the definition of a diagnostic device used to identify conditions or substances in a body.
No
The device description explicitly states it is a "lateral flow immunoassay," which is a hardware-based 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." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a person's health status (presence of drugs of abuse).
- Device Description: It's described as a "lateral flow immunoassay for the detection of drugs of abuse." Immunoassays are a common type of IVD test.
- Performance Studies: The document describes performance studies comparing the device to other legally marketed devices and using confirmed positive and negative samples. This is typical for the validation of an IVD.
- Professional Use Only: While not a definitive marker on its own, the "For professional use only" statement often indicates a device intended for use in a clinical or laboratory setting, which is where IVDs are typically used.
The core function of analyzing a human sample (urine) outside the body to detect specific substances (drugs of abuse) for diagnostic or screening purposes clearly aligns with the definition of an In Vitro Diagnostic device.
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 | Abbreviation | Level |
|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 ng/ml |
| Opiates (morphine-3-P-D glucuronide) | OPIATES | 2000 ng/ml |
| Phencyclidine (phencyclidine HCl) | PCP | 25 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.
Product codes
DKZ, DJG, LCM, DIO, 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
STARTOX™ drugs of abuse screening test detects 5 drugs in human urine at the levels indicated.
Product performance was compared Medtox Profile II manufactured by Medtox Diagnostics. Ninety (90) samples were tested against each drug, 50 negative which were confirmed to be drug free and 40 positive specimens for each drug were screened as positive by Emit, confirmed and quantified by GC/MS.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
STARTOX™ is substantial equivalent to Rapid Drug Screen 9 panel manufactured by American BioMedica Corporation 510k number K002447.
The STARTOX™ Drugs of Abuse Screening Test was compared to a FDA substantially equivalent approved device, Medtox Profile II. STARTOX™ demonstrated greater than 99% accuracy with when compared to a 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 STARTOXTM Drugs of Abuse Screening Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Accuracy stated as > 99%)
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
JUN 1 0 2002
Starplex Scientific Inc. 510k Submission K021006 Additional Information 6/6/02
510 (K) SUMMARY
Page 3 of 19
Date of Summary
June 4, 2002
Product Name:
STARTOX™
Sponsor and Manufacturer:
Starplex Scientific, Inc. 50 Steinway Blvd. Etobicoke, Ontario, Canada M9W 6Y3
Correspondent:
Fran White MDC Associates 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Device:
Product: Rapid Drug Screen - 9 panel Manufactured by: American BioMedica Corp 510k Number: K002447
Product Description:
A lateral flow immunoassay for the detection of drugs of abuse.
1
Starplex Scientific Inc. 510k Submission K021006 Additional Information 6/6/02
Page 4 of 19
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 |
|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 ng/ml |
| Opiates (morphine-3-P-D glucuronide) | OPIATES | 2000 ng/ml |
| Phencyclidine (phencyclidine HCl) | PCP | 25 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.
PERFORMANCE CHARACTERISTICS:
STARTOX™ drugs of abuse screening test detects 5 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 was compared Medtox Profile II manufactured by Medtox Diagnostics. Ninety (90) samples were tested against each drug, 50 negative which were confirmed to be drug free and 40 positive specimens for each drug were screened as positive by Emit, confirmed and quantified by GC/MS.
The STARTOX™ Drugs of Abuse Screening Test was compared to a FDA substantially equivalent approved device, Medtox Profile II. STARTOX™ demonstrated greater than 99% accuracy with when compared to a legally marketed device.
2
Starplex Scientific Inc. 510k Submission K021006 Additional Information 6/6/02
Page 5 of 19
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 STARTOXTM Drugs of Abuse Screening Test.
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 features a stylized eagle with three horizontal lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 0 2002
Starplex Scientific, Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915
Re: K021006
Trade/Device Name: Startox™ Drug of Abuse Screening Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ; DJG; LCM; DIO; LDJ Dated: March 27, 2002 Received: March 28, 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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
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 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
5
Starplex Scientific Inc. 510k Submission K021006 Additional Information 6/6/02
Page 6 of 19
510(k) Number: Device Name: STARTOXTM 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 |
|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 ng/ml |
| Opiates (morphine-3-P-D glucuronide) | OPIATES | 2000 ng/ml |
| Phencyclidine (phencyclidine HCl) | PCP | 25 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 -Off)
Division o Clinical Laboratory Devices
510(k) Numes: K221006
(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)