The ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with three types of Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates. Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethamphetamine in human urine at the cutoff concentrations of:

50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 1,000 ng/mL for Amphetamine, 2,000 or 300 ng/mL for Opiates (OPI2000 or MOP300), 25 ng/mL for Phencyclidine, 300 ng/mL for Benzodiazepine, 300 ng/mL for Methadone, 300 ng/mL for Barbiturate. 1,000 ng/mL for Tricyclic Antidepressants, and 500 ng/mL for Methylenedioxymethamphetamine

These assay systems can only provide a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, especially when preliminary positive results are indicated.

They are only intended for healthcare professionals including professionals at point of care sites.

Device Description

The ACON Spectrum Multi-Drug Multi-Line Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Screen Test Card with Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Antidepressants Benzodiazepine. Methadone, Barbiturate, Tricyclic and Methylenedioxymethamphetamine in human urine at the cutoff concentrations of:

50 ng/mL for Marijuana. 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 1,000 ng/mL for Amphetamine, 2,000 or 300 ng/mL for Opiates (OPI2000 or MOP300), 25 ng/mL for Phencyclidine, 300 ng/mL for Benzodiazepine, 300 ng/mL for Methadone, 300 ng/mL for Barbiturate, 1,000 ng/mL for Tricyclic Antidepressants, and 500 ng/mL for Methylenedioxymethamphetamine.

These tests can be performed without the use of an instrument.

A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic -Antidepressants and Methylenedioxymethamphetamine at the concentrations below the designated cut-off levels will generate a colored-line in the designated test region for the drug. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

AI/ML Overview

The acceptance criteria and device performance information for the ACON Spectrum Multi-Drug Multi-Line Screen Test Card is derived from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance in terms of the ability of the device to detect specific drugs at or above certain cutoff concentrations. The "acceptance criteria" for a qualitative immunoassay like this are inherently tied to its ability to correctly identify positive and negative samples relative to these cutoffs.

Drug	Cutoff Concentration (Acceptance Criteria)	Device Performance (How tested/described)
Marijuana	50 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)
Cocaine	300 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)
Methamphetamine	1,000 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)
Amphetamine	1,000 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)
Opiates (OPI2000)	2,000 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)
Opiates (MOP300)	300 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)
Phencyclidine	25 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)
Benzodiazepine	300 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)
Methadone	300 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)
Barbiturate	300 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)
Tricyclic Antidepressants	1,000 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)
Methylenedioxymethamphetamine (MDMA)	500 ng/mL	Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff)

2. Sample Size Used for the Test Set and Data Provenance:

The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It describes the device and its intended use but does not detail the specific performance study results, including the number of samples tested to demonstrate its accuracy against the stated cutoffs.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

The text does not mention the number or qualifications of experts used to establish ground truth for any test set. For this type of device, ground truth would typically be established by a reference chemical method (e.g., GC/MS), not by expert human interpretation of the device results.

4. Adjudication Method for the Test Set:

Since there's no mention of a test set being interpreted by human experts or clinical adjudication, there is no adjudication method described in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This device is a rapid chromatographic immunoassay, not an AI-powered diagnostic imaging or interpretation tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not done and is not applicable to this device.

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

The device itself is a standalone test; it's a "rapid chromatographic immunoassay" that can be "performed without the use of an instrument." The performance described ("A positive urine specimen will not generate a colored-line...") is the standalone performance of the device in detecting the drug. The results are visually interpreted by a healthcare professional, but the core detection mechanism is the autonomous chemical reaction within the test card.

7. The Type of Ground Truth Used:

The type of ground truth used for such a device is implied to be chemical confirmation, specifically GC/MS (Gas Chromatography/Mass Spectrometry). The document states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method." This indicates that GC/MS serves as the gold standard for confirming the presence or absence of the drugs and their concentrations, against which the immunoassay's performance would be compared.

8. The Sample Size for the Training Set:

The provided text does not mention a training set sample size. This type of immunoassay device is developed through chemical and biological formulation and optimization, not typically through machine learning from a "training set" in the computational sense.

9. How the Ground Truth for the Training Set was Established:

As there is no mention of a training set in the context of machine learning, there is no information on how ground truth for a training set was established. The development and "training" of this type of device would involve laboratory testing with known concentrations of analytes and interferents to optimize the chemical reagents and physical design for accurate detection at the specified cutoffs.

Summary

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AUG - 4 2003

SUMMARY OF 510(k)

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

The Assigned 510(k) number is K031759.

Submitter:

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

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

Date:

July 28, 2003

Contact Person:

Edward Tung, Ph.D.

Product Names:

ACON Spectrum Multi-Drug Multi-Line Screen Test Card

ACON Spectrum Multi-Drug Multi-Line Screen Test Card with Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup)

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Common Name:

Immunochromatographic test for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethamphetamine in human urine.

Device Classification:

Marijuana. Cocaine. Methamphetamine. Amphetamine. Opiates. Phencyclidine, Benzodiazepine. Methadone, Barbiturate. Tricyclic Antidepressants and Methylenedioxymethamphetamine test systems have been classified as Class II devices with moderate complexity.

The ACON One Step Multi-Line Screen Test Card and Test Device are similar to other FDA-cleared devices for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethamphetamine in human urine.

Intended Use:

The ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with three types of Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup, and ACON 009 Cup or E-Z Split Key Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates. Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethamphetamine in human urine.

These assay systems can only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, especially when preliminary positive results are indicated.

They are only intended for healthcare professionals including professionals at point of care sites.

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Description:

These tests can be performed without the use of an instrument.

Unmodified ACON Devices

The ACON® Spectrum Multi-drug Multi-line Drug Screen Test Card (12-in-4) is a "combined" product format of the two previously cleared 6-in-2 ACON One Step Multi-drug Multi-line Drug Test Card. The test Cards in these 6-in-2 formats have up to six DOA tests on one or two Test Strips. These two legally marketed but unmodified devices and their 510(k) numbers under which they were previously cleared are listed in Table 1.

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ACON DOA Test		KNumber	ProductCode
1. ACON One Step Multi-drug Multi-line Test Card & Test Devicewith drug calibrator and cutoff concentration used for each analyte listed
COCAINE ((Benzoylecgonine)	300 ng/mL	K020313	DIO
AMPHETAMINE (Amphetamine)	1,000 ng/mL		DKZ
OPIATES (Morphine)	2,000 ng/mL		DIG
METHAMPHETAMINE (Methamphetamine)	1,000 ng/mL		LAF
MARIJUANA (Δ-11-nor-9-THC-9-COOH)	50 ng/mL		LDJ
Phencyclidine (PCP)	25 ng/mL		LCM
2. ACON One Step Multi-drug Multi-line Test Card & Test Device (II)with drug calibrator and cutoff concentration used for each analyte listed		K023946
TRICYCLIC ANTIDEPRESSANTS (Nortriptyline)	1,000 ng/mL		DJC
MDMA (Methylenedioxymethamphetamine)	500 ng/mL		LFG
BENZODIAZEPINE (Oxazepam)	300 ng/mL		JXM
METHADONE (Methadone)	300 ng/mL		DJR
BARBITURATES (Secobarbital)	300 ng/mL		DIS
MORPHINE (Morphine)	300 ng/mL		DJG

Table 1. Unmodified ACON Devices with K Numbers and Product Codes.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

AUG - 4 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K031759

Trade/Device Name: ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ; DIO; DJC; DKZ; DJG; LCM; JXM; DJR; DIS; LFG Dated: July 7, 2003 Received: July 11, 2003

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).

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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

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INDICATION FOR USE:

510(k) Number: K031759

Device Name: ACON Spectrum Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup)

Indications for Use: The ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with three types of Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous derection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates. Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethampheramine in human urine at the cutoff concentrations of:

They are only intended for healthcare professionals including professionals at point of care sites.

(Please do not write below this point)
Concurrence of CDRH, Office of In Vitro Device Evaluation and Safety

Prescription Use	✓	Or	over-the-counter Use ______
(Per 21 CFR 801.109)

Division Sign-Off For, Jean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
K 031759

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).