(74 days)
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.
A lateral flow immunoassay for the detection of drugs of abuse.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Compound (Abbreviation) | Acceptance Criteria (Level) | Reported Device Performance |
|---|---|---|
| Amphetamine (AMP) | 1000 ng/ml | Greater than 99% accuracy |
| Opiates (OPIATES) | 2000 ng/ml | Greater than 99% accuracy |
| Phencyclidine (PCP) | 25 ng/ml | Greater than 99% accuracy |
| Cocaine (COCAINE) | 300 ng/ml | Greater than 99% accuracy |
| Cannabinoids (THC) | 50 ng/ml | Greater than 99% accuracy |
Notes on the table:
- The acceptance criteria are the "Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels" at which the device is intended to detect the drugs.
- The reported device performance is a single aggregated metric ("greater than 99% accuracy") stated against a legally marketed device (Medtox Profile II). The document does not provide separate accuracy figures for each compound, nor does it specify the accuracy relative to the SAMHSA cut-off levels in this particular section (though the study involved testing above and below cut-offs for reproducibility). The "greater than 99% accuracy" is essentially the device meeting its substantial equivalence claim against a predicate, implying it performs at least as well.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 90 samples were tested for each drug. This means:
- 90 samples for Amphetamine.
- 90 samples for Opiates.
- 90 samples for Phencyclidine.
- 90 samples for Cocaine.
- 90 samples for Cannabinoids.
Each set of 90 samples consisted of 50 negative specimens and 40 positive specimens.
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using previously collected samples that were confirmed as drug-free or screened positive and confirmed by GC/MS.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. The ground truth (confirmation of drug presence/absence and quantification) was established by analytical methods (GC/MS and Emit screening), not by human experts.
4. Adjudication Method for the Test Set
- Not applicable as the ground truth was established by analytical methods (Emit screening and GC/MS), not human interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a lateral flow immunoassay (a point-of-care type test), not an AI-assisted diagnostic device requiring human interpretation in an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is effectively a standalone study. The device is a diagnostic assay that provides a direct result (positive/negative) without human interpretation as part of the core test mechanism. Its performance was evaluated against analytical gold standards.
7. The Type of Ground Truth Used
- The ground truth was established using analytical methods:
- Negative samples were "confirmed to be drug free" (method not specified for this confirmation, but implied to be robust).
- Positive specimens were "screened as positive by Emit, confirmed and quantified by GC/MS." GC/MS (Gas Chromatography/Mass Spectrometry) is explicitly stated as the preferred confirmatory method and the method used for quantification.
8. The Sample Size for the Training Set
- This information is not explicitly provided. As a lateral flow immunoassay, it is a hardware-based diagnostic device, not a machine learning algorithm that typically undergoes a "training phase" with a labeled dataset in the same way. Its development would involve calibrating the assay components and reagents, which isn't typically referred to as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons mentioned in point 8. The "training" or development of such an assay involves chemical and biological engineering to ensure the reagents perform as expected, rather than "ground truth" derived from a specific dataset for algorithmic learning.
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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.
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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.
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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.
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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.
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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 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
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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)
§ 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).