"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.

For professional use only.

Device Description

A lateral flow immunoassay for the detection of drugs of abuse.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance

The document states that the STARTOX™ Drugs of Abuse Screening Test is substantially equivalent to a legally marketed predicate device. The performance is assessed by comparison to other approved devices (Medtox Profile II and RDS 9) and subsequently confirmed to be substantially equivalent.

Table of Acceptance Criteria and Reported Device Performance:

Compound	Abbreviation	Level (Acceptance Criterion)	Reported Device Performance
Methamphetamine ((+/-)methamphetamine HCl)	METH	1000 ng/ml	Performed substantially equivalent to the legally marketed device against the stated level.
Opiates (morphine)	OPI	300 ng/ml	Performed substantially equivalent to the legally marketed device against the stated level.
Cocaine (benzoylecgonine)	COC	300 ng/ml	Performed substantially equivalent to the legally marketed device against the stated level.
Cannabinoids (11-nor-Δ9-THC-9-carboxylic-acid)	THC	50 ng/ml	Performed substantially equivalent to the legally marketed device against the stated level.

Note: The acceptance criteria for the STARTOX™ device are implicitly its ability to detect the specified compounds at the listed SAMHSA recommended levels with comparable performance to the predicate devices. The study concludes that the device performed substantially equivalent to the legally marketed predicate devices, thereby meeting the acceptance criteria of being comparable in performance.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: 90 samples were tested against each drug (4 drugs), consisting of 50 negative and 40 positive specimens. This means a total of 90 samples per drug, so 90 x 4 = 360 individual tests were performed across the four drugs.
- Data Provenance: Not explicitly stated, but typically for in vitro diagnostic device studies, samples would be collected from a relevant population (e.g., clinical samples, drug screening samples). It is retrospective as the "drug status of these samples was tested by EMIT and quantified by GC/MS," indicating these were pre-existing samples with established ground truth. The country of origin is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable, as expert consensus was not the primary method for establishing ground truth.
- Qualifications of Experts: Not applicable.
Adjudication method for the test set:
- Adjudication Method: Not applicable. The ground truth was established by quantitative analytical methods rather than expert adjudication.
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:
- MRMC Study: No, this was not a MRMC study. This device is a lateral flow immunoassay for in vitro diagnostic use, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the study evaluates the performance of the STARTOX™ device directly, comparing its results to established analytical methods and predicate devices. This represents its standalone performance. The device provides a "preliminary qualitative test result" which is then confirmed by other methods, implying its standalone role as a screening tool.
The type of ground truth used:
- Ground Truth Type:
  - EMIT (Enzyme Multiplied Immunoassay Technique): A commonly used immunoassay for drug screening, often considered a good initial positive/negative indicator.
  - GC/MS (Gas Chromatography/Mass Spectrometry): Stated as the "preferred confirmatory method" and used for quantification. GC/MS is widely considered the gold standard for drug confirmation due to its high specificity and sensitivity.
  - Therefore, the ground truth was established using a combination of a commonly accepted screening method (EMIT) and the gold standard analytical method (GC/MS) for quantification and definitive drug status.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This document describes a performance validation study for an immunoassay, not a machine learning model that requires a distinct training set.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there was no training set in the context of a machine learning model.

Summary

{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:

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

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:

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

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)

Regulation Number and Section

§ 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).