AMEDITECH IMMU TEST DRUG SCREEN PANEL by AMEDITECH, INC.

The Ameditech ImmuTest Drug Screen Panel is a one-step panel immunoassay for the qualitative detection of amphetamine, cocaine metabolite (benzovlecgonine), methamphetamine, opiates, phencyclidine, and THC in human urine. The cutoff concentrations for this panel test are amphetamine at 1000 ng/ml, cocaine metabolite at 300 ng/ml, methamphetamine at 500 ng/ml, opiates at 2000 ng/ml, phencyclidine at 25 ng/ml, and THC at 50 ng/ml. This test kit is used to obtain a visual, qualitative results and is intended for professional use.

Device Description

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AI/ML Overview

The provided FDA 510(k) summary (K040092) for the Ameditech ImmuTest Drug Screen Panel does not contain detailed information about the acceptance criteria and the study that proves the device meets them. This document is primarily the FDA's letter of substantial equivalence and the Indications For Use statement.

Therefore, many of the requested details cannot be extracted directly from the given text. However, based on the nature of a 510(k) submission for an in vitro diagnostic device, we can infer some general aspects and fill in what is available within the provided pages.

General Understanding of 510(k) Studies for IVDs:
For in vitro diagnostic devices like drug screens, performance studies typically involve testing known positive and negative samples, as well as samples with drug concentrations around the specified cutoff to determine sensitivity, specificity, and accuracy. The "acceptance criteria" would generally be predefined thresholds for these performance metrics. "Ground truth" for IVDs is usually established by a highly accurate reference method (e.g., GC/MS for drug screening).

Information Available from the Provided Text:

Device Name: Ameditech ImmuTest Drug Screen Panel
Intended Use: Qualitative detection of amphetamine, cocaine metabolite (benzoylecgonine), methamphetamine, opiates, phencyclidine, and THC in human urine.
Cutoff Concentrations:
- Amphetamine: 1000 ng/ml
- Cocaine metabolite: 300 ng/ml
- Methamphetamine: 500 ng/ml
- Opiates: 2000 ng/ml
- Phencyclidine: 25 ng/ml
- THC: 50 ng/ml

Based on the provided text, here is an attempt to answer the questions, with significant limitations due to lack of the actual study report:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided documents. For a qualitative drug screen, typical acceptance criteria would involve a certain percentage of agreement (e.g., >95% or >98%) with a reference method for both positive and negative samples, and high accuracy around the cutoff concentrations.
Reported Device Performance: Not explicitly stated in the provided documents. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices, implying its performance met the requirements set by the FDA for such devices.

Analyte	Cutoff Concentration	Acceptance Criteria (Inferred)	Reported Device Performance (Not in document)
Amphetamine	1000 ng/ml	e.g., >95% agreement with GC/MS	(performance data not provided)
Cocaine Metabolite	300 ng/ml	e.g., >95% agreement with GC/MS	(performance data not provided)
Methamphetamine	500 ng/ml	e.g., >95% agreement with GC/MS	(performance data not provided)
Opiates	2000 ng/ml	e.g., >95% agreement with GC/MS	(performance data not provided)
Phencyclidine	25 ng/ml	e.g., >95% agreement with GC/MS	(performance data not provided)
THC	50 ng/ml	e.g., >95% agreement with GC/MS	(performance data not provided)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not stated in the provided documents.
Data Provenance: Not stated in the provided documents. Typically, for IVDs, this would involve clinical samples collected from hospitals, clinics, or drug testing facilities. Most likely, a prospective collection or a defined retrospective bank of samples would be used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable in the typical sense for IVD drug screens.
Qualifications of Experts: The ground truth for drug screen tests is typically established by an independent, highly accurate reference method, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS), performed by qualified laboratory personnel (e.g., clinical chemists, toxicologists). It does not usually involve expert "readers" in the way imaging studies do.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable for IVD drug screens in the context of expert review. The "adjudication" is essentially the comparison of the device's qualitative result (positive/negative) to the quantitative result of the reference method around the cutoff, confirmed by expert interpretation of the reference method data.

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

MRMC Study: Not applicable. This device is a rapid, qualitative immunoassay for drug detection, and the evaluation does not involve human readers interpreting images or complex data, nor does it typically involve AI assistance in the interpretation of the physical test device. The device provides a visual result (e.g., lines appearing).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: For this type of device, the "standalone performance" is the performance of the immunoassay itself, without human interpretation error. Since it's a visual read, human-in-the-loop is inherent for interpreting the lines, but the primary performance evaluation focuses on the chemical accuracy of the assay. The data provided does not specify how read-out variability was assessed, if at all.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Likely an objective, highly accurate reference method such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS). These methods provide quantitative results, allowing for precise determination if a sample is above or below the specified cutoff concentration.

8. The sample size for the training set

Sample Size (Training Set): Not stated in the provided documents. For simple immunoassays, a "training set" in the machine learning sense is not typically used for algorithm development; rather, assay parameters are optimized during R&D using a set of characterized samples.

9. How the ground truth for the training set was established

Ground Truth (Training Set): Not detailed in the provided documents. If a "training set" was used for assay optimization, its ground truth would have been established by similar reference methods (e.g., GC/MS, LC/MS) as the test set, ensuring that the samples used for development accurately reflected known drug concentrations.

Summary of Limitations:
The provided document is a regulatory approval letter and an "Indications for Use" statement, not the detailed study report. Therefore, specific performance data, acceptance criteria, sample sizes, and detailed methodology of the validation study are not included in these pages. Such information would typically be found in the full 510(k) submission, which is not publicly available in this level of detail.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 8 2004

John Wu. Ph.D. Director of Quality Assurance Ameditech, Inc. 10340 Camino Santa Fe - Suite F San Diego, CA 92121

Re: K040092

Trade/Device Name: Ameditech ImmuTest Drug Screen Panel Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ; DIO; DJC; DJG; LCM; DKE Dated: January 5, 2004 Received: January 16, 2004

Dear Dr. Wu:

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 Fedcral 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).

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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,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Attachment C

Indications for Use Statement

Page of

K040092 510(k) Number (if known):

Ameditech ImmuTest Drug Screen Panel Device Name:

Indications For Use:

This test kit is used to obtain a visual, qualitative results and is intended for professional use.

Carol Benson
Division Sign-Off

Office of In Vitro Diagnos Device Evaluation and Sa

510(k) K040092

(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)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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).