The On-Call™ Multi-Drug Home Test Cup is a screening test for the rapid detection of drugs in urine at a designated cut-off concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Amphetamine, 1,000 ng/mL for Methamphetamine, 500 ng/mL for Ecstasy, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. The test is intended for over-the-counter (OTC) consumer use.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Device Description

The On-Call™ Multi-Drug Home Test Cup is a rapid lateral flow immunoassay for the qualitative detection of drugs in urine at a cutoff concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Amphetamine, 1,000 ng/mL for Methamphetamine, 500 ng/mL for Ecstasy, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. This test is used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis. They are intended for the over-the-counter lay person use.

The On-Call™ Multi-Drug Home Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative screening of Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, and Phencyclidine in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of drugs, and their metabolites in urine at a cutoff concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 500 ng/ml for Ecstasy, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. This test can be performed without the use of an instrument.

A drug-positive urine specimen will not generate colored-lines in the designated test region, while A urine specimen or a urine specimen containing Marijuana, Cocaine, Amphetamine, a megative anne specimen or a anno epididine at the concentration below the cutoff level will generate colored-lines in the test region. To serve as a procedural control, a colored-line whit generate control miss in antol region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

AI/ML Overview

The provided text does not contain acceptance criteria for the device, nor does it detail a study performed to prove the device meets specific acceptance criteria in the way described in the request.

Instead, the document is a 510(k) summary for a drug test cup. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (ACON Spectrum Multi-Drug Multi-Line Drug Screen Test, K031759) and establishing the device's technical characteristics and intended use.

Here's an breakdown of why the requested information cannot be extracted from the provided text:

No explicit acceptance criteria table: The document does not list specific sensitivity, specificity, accuracy, or other performance metrics as acceptance criteria.
No detailed study report: The document states that the new device (On-Call™ Multi-Drug Home Test Cup) is "identical to the ACON Key Cup (K031759) that is legally marketed for professional use." It then argues that "there is no issue regarding the safety or effectiveness of the product to perform its intended function" because of this similarity and the device's simple operation. This is a declaration of equivalence rather than a report of a new study proving performance against defined criteria.
Focus on Substantial Equivalence: The FDA's letter confirms substantial equivalence to a predicate device, which is a regulatory pathway, not a detailed performance study.

Therefore, many parts of the requested table and information points cannot be filled based on the provided document.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance
As stated, the document does not contain explicit acceptance criteria or a dedicated performance study for the On-Call™ Multi-Drug Home Test Cup. The performance is implied to be equivalent to the predicate device due to identicality.

Performance Metric	Acceptance Criteria	Reported Device Performance
Marijuana (THC)	Not specified	Qualitatively detects THC at a cutoff of 50 ng/mL. Implied to be equivalent to predicate K031759.
Cocaine (COC)	Not specified	Qualitatively detects COC at a cutoff of 300 ng/mL. Implied to be equivalent to predicate K031759.
Amphetamine (AMP)	Not specified	Qualitatively detects AMP at a cutoff of 1,000 ng/mL. Implied to be equivalent to predicate K031759.
Methamphetamine (mAMP)	Not specified	Qualitatively detects mAMP at a cutoff of 1,000 ng/mL. Implied to be equivalent to predicate K031759.
Ecstasy (MDMA)	Not specified	Qualitatively detects MDMA at a cutoff of 500 ng/mL. Implied to be equivalent to predicate K031759.
Opiates (OPI)	Not specified	Qualitatively detects OPI at a cutoff of 2,000 ng/mL. Implied to be equivalent to predicate K031759.
Phencyclidine (PCP)	Not specified	Qualitatively detects PCP at a cutoff of 25 ng/mL. Implied to be equivalent to predicate K031759.

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: Not specified. The document relies on the equivalence to a previously cleared device rather than presenting new test set data.
Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no new test set and associated ground truth establishment process is described.

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

Not applicable as no new test set is described.

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 rapid immunoassay for qualitative detection of drugs, not an AI-assisted diagnostic tool requiring human reader studies.

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

The device is a standalone test in that it provides a result without an instrument or human interpretation for its primary detection, though confirmation by GC/MS is required for positive results. However, no "standalone performance study" in the context of an algorithm is presented.

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

For the predicate device (K031759) and by implication for this equivalent device, the principle of ground truth for drug testing is typically established by definitive confirmatory methods like Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis."

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable. This is not an AI/machine learning device.

Summary

{0}------------------------------------------------

10. 510(k) SUMMARY

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The Assigned 510(k) number is 1050878

Submitter:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel.: 858-535-2030 Fax: 858-535-2038

Date:

April 4, 2005

Contact Person:

Edward Tung, Ph.D.

Product Names:

On-Call™ Multi-Drug Home Test Cup for Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, and Phencyclidine

Common Name:

Immunochromatographic test for the qualitative detection of Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, and Phencyclidine in urine.

Regulation Name:

Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, and Phencyclidine test system.

{1}------------------------------------------------

Product Code:

LDJ, DIO, DKZ, LAF, DJG, LCM

Classification Number:

21 CFR 862.3870, 21 CFR 862.3250, 21 CFR 862.3100, 21 CFR 862.3610, 21 CFR 862.3650

Device Classification:

The Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, and Phencyclidine test systems have been classified as Class II devices with moderate complexity. The On-Call™ Multi-Drug Home Test Cup is similar to another FDA-cleared device (ACON Spectrum Multi-Drug Multi-Line Drug Screen Test, K031759) for the qualitative detection of Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, and Phencyclidine in urine specimens. This test is used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis.

Statement of Intended Use Compared to Other Products:

Discussion of Technological Characteristics:

{2}------------------------------------------------

Safety and Effectiveness Data:

Because the On-Call™ Multi-Drug Home Test Cup is identical to the ACON Key Cup (K031759) that is legally marketed for professional use; and because no special skills, training, education, or that is legarry marketed for percession a urine sample into the test card well, there is no issue regarding the safety or effectiveness of the product to perform its intended function, i.e., to screen urine for the presence or absence of THC, COC, AMP, mAMP, MDMA, OPI, PCP, and Screen unne for the probeiles of acce. Call™ Multi-Drug Home Test Cup is similar to a variety then measonner - 11-5 x wently in commercial distribution in the U.S., including the Phamatech or rapid soroming test. There have been no reports of consumer inability to follow instructions or interpret results over the many months these products have been marketed, it should be concluded that the product can be used effectively by a lay user.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

JUN 8 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121

Re: K050878

Trade/Device Name: On-Call™ Multi-Drug Home Test Cup for Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates and Phencyclidine Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ, DIO, DKZ, LAF, DJG, LCM Dated: April 4, 2005 Received: April 6, 2005

Dear Dr. Tung:

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}------------------------------------------------

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, rr you stions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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/industry/support/index.html.

Sincerely vours.

Carol C. Benam

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

13. INDICATIONS FOR USE

510(k) Number (if known): K050878

Device Name: On-Call™ Multi-Drug Home Test Cup for Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, and Phencyclidine

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Rutt a chaste

Division Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD50878

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).