The ACON multi-CLIN™ Drug Screen Test Device is a rapid chromatographic immunoassays for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine at cut-off concentrations:

1,000 ng/mL Amphetamine
300 ng/mL Barbiturates
300 ng/mL Benzodiazepines
300 ng/mL Cocaine
50 ng/mL Marijuana
500 ng/mL Methylenedioxymethamphetamine
300 ng/mL Opiates
100 ng/mL Oxycodone
25 ng/mL Phencyclidine
300 ng/mL Propoxyphene
1,000 ng/mL Tricyclic Antidepressants

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

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 used.

Device Description

The ACON multi-CLIN™ Drug Screen Test Device is a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine.

The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibodies to selectively detect elevated levels of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine. These tests can be performed without the use of an instrument.

A drug-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 the drug concentration below the cut-off level will generate a colored-line in the designated test region for the drug. To serve as a procedural control, there must be no line next to the Positive Control Region (POS) and a clear line will always appear in the Negative Control region (NEG), indicating that sufficient volume of specimen applied and proper membrane wicking occurred. If NO line appears in the Negative Control region (NEG) and/or a line withing other Positive Control Region (POS) during testing, the test becomes INVALID. A true positive control is incorporated in each test strip employed.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ACON multi-CLIN™ Drug Screen Test Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the desired level of agreement for each drug tested, as demonstrated by the study results when compared to GC/MS analysis. While explicit percentage targets aren't listed as "acceptance criteria," the reported performance in the table below represents what was accepted as substantially equivalent.

Analyte (Drug)	Performance Measure	Acceptance Criteria (Implied by Study)	Reported Device Performance
Amphetamine (AMP)	Positive Agreement	High (>90%)	99% (134/136)
	Negative Agreement	High (>90%)	98% (308/314)
	Overall Agreement	High (>90%)	98% (442/450)
Barbiturates (BAR)	Positive Agreement	High (>90%)	98% (99/101)
	Negative Agreement	High (>90%)	99% (305/309)
	Overall Agreement	High (>90%)	99% (404/410)
Benzodiazepines (BZO)	Positive Agreement	High (>90%)	>99% (139/140)
	Negative Agreement	High (>90%)	>99% (308/310)
	Overall Agreement	High (>90%)	>99% (447/450)
Cocaine (COC)	Positive Agreement	High (>90%)	>99% (119/119)
	Negative Agreement	High (>90%)	95% (308/325)
	Overall Agreement	High (>90%)	96% (427/444)
Marijuana (THC)	Positive Agreement	High (>90%)	96% (116/121)
	Negative Agreement	High (>90%)	95% (311/327)
	Overall Agreement	High (>90%)	95% (427/448)
MDMA	Positive Agreement	High (>90%)	>99% (88/88)
	Negative Agreement	High (>90%)	99% (301/305)
	Overall Agreement	High (>90%)	99% (389/393)
Opiates (OPI)	Positive Agreement	High (>90%)	>99% (140/140)
	Negative Agreement	High (>90%)	97% (300/309)
	Overall Agreement	High (>90%)	98% (440/449)
Oxycodone (OXY)	Positive Agreement	High (>90%)	99% (140/141)
	Negative Agreement	High (>90%)	99% (306/309)
	Overall Agreement	High (>90%)	99% (446/450)
Phencyclidine (PCP)	Positive Agreement	High (>90%)	99% (85/86)
	Negative Agreement	High (>90%)	99% (300/304)
	Overall Agreement	High (>90%)	99% (385/390)
Propoxyphene (PPX)	Positive Agreement	High (>90%)	>99% (145/146)
	Negative Agreement	High (>90%)	>99% (304/304)
	Overall Agreement	High (>90%)	>99% (449/450)
Tricyclic Antidepressants (TCA)	Positive Agreement	High (>80%)	>99% (32/32)
	Negative Agreement	High (>80%)	93% (316/338)
	Overall Agreement	High (>80%)	94% (348/370)

Note: The specific percentage acceptance criteria are not explicitly stated in the provided text, but the strong agreement percentages demonstrate that the device met the requirements for substantial equivalence.

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

Sample Size for Test Set: 1,704 clinical urine specimens.
Data Provenance: The data was from "clinical urine specimens," implying human samples, and a portion (approximately 10%) included samples with drug concentrations in the -25% to +25% cut-off range to challenge the device at critical concentrations. The country of origin is not specified but given the FDA submission, it's likely US-based or intended for the US market. The study was retrospective in nature as it compared the device against existing predicate devices and customary GC/MS analysis.

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

Number of Experts: Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is an analytical instrument-based method, not human expert interpretation in this context.
Qualifications of Experts: Not applicable, as GC/MS is a laboratory analytical method.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth was established by GC/MS, which provides quantitative, objective results. Discrepancies would be resolved through re-testing or review of the GC/MS data, rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone analytical accuracy of the device against a gold standard (GC/MS).
Effect Size of AI Improvement: Not applicable, as this was not an AI-assisted human reader study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Yes, a standalone study was performed. The "ACON Multi-CLIN™ Drug Screen Test Device vs. GC/MS Analysis" section directly reports the performance of the device (product) working independently, compared to the GC/MS gold standard. There is no mention of human interpretation being part of the device's output or a human-in-the-loop process for these results. The device itself produces the qualitative result (positive/negative).

7. Type of Ground Truth Used

Type of Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS) analysis. GC/MS is considered the gold standard for confirmatory drug testing due to its sensitivity and specificity in identifying and quantifying substances.

8. Sample Size for the Training Set

Sample Size for Training Set: The document does not specify a separate training set. The clinical evaluation used 1,704 clinical specimens for testing the device's performance. For immunoassay devices like this, the "training" (development and calibration) would typically involve internal laboratory studies using spiked samples and known-concentration controls during the manufacturing and R&D phases, but a distinct "training set" for an algorithm in the sense of machine learning is not mentioned as this is a chemical immunoassay device.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not explicitly stated in the document, as a training set for an algorithm is not described. For the general development of such immunoassay devices, ground truth for calibration and initial validation (analogous to training) would typically be established using:
- Known concentrations of drugs or their metabolites prepared in a laboratory.
- Certified reference materials.
- Laboratory analysis using established methods like GC/MS to confirm the actual concentrations in prepared samples.

Summary

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AUG 3 0 2004

SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS 8.

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 K041685

Submitter:

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

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

Date:

June 18, 2004

Contact Person:

Edward Tung, Ph.D.

Product Names:

ACON® multi-CLIN™ Drug Screen Test Device

Common Name:

Immunochromatographic test for the simultaneously qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine.

Device Classification:

The ACON multi-CLIN™ Drug Screen Test Device is similar to other FDA-cleared devices for the qualitative and simultaneous detection of drugs in urine specimens. These drug tests are used only to provide a preliminary analytical result. The test systems have been classified as Class II devices with moderate complexity. Product codes DKZ, DIS, JXM, DIO, LDJ, LAF, DJG, LCM, JXN and LFG have been assigned for the test system.

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Classification Name:

Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants test systems

Intended Use:

1,000 ng/mL Amphetamine 300 ng/mL Barbiturates 300 ng/mL Benzodiazepines 300 ng/mL Cocaine 50 ng/mL Marijuana 500 ng/mL Methylenedioxymethamphetamine 300 ng/mL Opiates 100 ng/mL Oxycodone 25 ng/mL Phencyclidine 300 ng/mL Propoxyphene 1,000 ng/mL Tricyclic Antidepressants

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

Description:

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Positive Control Region (POS) and a clear line will always appear in the Negative Control region (NEG), indicating that sufficient volume of specimen applied and proper membrane wicking occurred. If NO line appears in the Negative Control region (NEG) and/or a line withing other Positive Control Region (POS) during testing, the test becomes INVALID. A true positive control is incorporated in each test strip employed.

Predicate Devices

Barbiturates, Benzodiazepines, Cocaine, Marijuana, Amphetamine, ACON Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants Single Drug Test Strips were used as the predicate devices for the ACON multi-CLIN™ Drug Screen Test Device to compare their performance with clinical urine specimens.

510(k) Numbers for these predicate devices are:

ACON AMP One Step Amphetamine Test Strip:	K011673
ACON BAR One Step Barbiturates Test Strip:	K012824
ACON BZO One Step Benzodiazepine Test Strip:	K012300
ACON COC One Step Cocaine Test Strip:	K010841
ACON THC One Step Marijuana Test Strip:	K003557
ACON MDMA One Step Ecstasy Test Strip:	K022589
ACON MOP One Step Opiates Test Strip:	K013380
ACON OXY One Step Oxycodone Test Strip:	K033047
ACON PCP One Step Phencyclidine Test Strip:	K011730
ACON PPX One Step Propoxyphene Test Strip:	K040445
ACON TCA One Step Tricyclic Antidepressants Test Strip:	K021526

Comparison to a Predicate Device:

A comparison of the features of the ACON® multi-CLIN™ Drug Screen Test Device versus the ACON One Step Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants Single Tests is shown below:

Both tests are immunoassays intended for the qualitative detection of Amphetamine, . Benzodiazepines, Cocaine, Cocaine, Marijuana, Methylenedioxy-Barbiturates, methamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in urine samples.
Both tests are intended as a screening method that provides a preliminary analytical . test result.
Both tests are immunochromatographic, lateral flow assays for the rapid detection . of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine,

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Propoxyphene, and Tricyclic Antidepressants and their derivatives with a visual, qualitative end result, while the ACON® multi-CLIN™ Drug Screen Test detects 2 to 11 of the above drugs simultaneously.

Both tests utilize the same basic immunoassay principles that rely on antigen/ . antibody interactions to indicate a positive or a negative result.
Both tests have the same cut-off concentration for a specific drug tested. .

Safety and Effectiveness Data:

Accuracy

A clinical evaluation was conducted using clinical urine specimens. This evaluation compared the test results between the ACON multi-CLIN™ Drug Screen Test Device versus previously FDA-cleared Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants Single tests; as well as against data obtained from the customary GC/MS analysis. 1,704 clinical specimens were employed including approximately 10% of the samples with drug concentrations in the -25% to +25% cut-off range. The comparisons of data obtained from this study yielded the following results:

Clinical study results of the ACON multi-CLIN™ Drug Screen Test Device are compared to GC/MS analysis data.

The GC/MS cut-off levels for each of the eleven drugs tested are as follows:

Amphetamine	1,000 ng/mL
Barbiturates	300 ng/mL
Benzodiazepines	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methylenedioxymethamphetamine	500 ng/mL
Opiates	300 ng/mL
Oxycodone	100 ng/mL
Phencyclidine	25 ng/mL
Propoxyphene	300 ng/mL
Tricyclic Antidepressants	1,000 ng/mL

Samples with drug concentration above the cut-off level were considered presumptive positive and concentrations below the cut-off are considered negative.

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ACON Multi-CLIN™ Drug Screen Test Device

vs.

GC/MS Analysis

	ACON Test Device Positive Agreement	Negative Agreement	Overall Agreement
AMP	134/136 = 99%(95% - 99%)*	308/314 = 98%(96% - 99%)*	442/450 = 98%(97% - 99%)*
BAR	99/101 = 98%(93% - 99%)	305/309 = 99%(97% - 99%)*	404/410 = 99%(97% - 99%)*
BZO	139/140 > 99%(96% - 99%)*	308/310 > 99%(98% - 99%)*	447/450 > 99%(98% - 99%)*
COC	119/119 > 99%(97% - 99%)**	308/325 = 95%(92% - 97%)*	427/444 = 96%(94% - 98%)*
THC	116/121 = 96%(91% - 99%)*	311/327 = 95%(92% - 97%)*	427/448 = 95%(93% - 97%)*
MDMA	88/88 > 99%(96% - 99%)**	301/305 = 99%(97% - 99%)*	389/393 = 99%(97% - 99%)*
OPI	140/140 > 99%(97% - 99%)**	300/309 = 97%(95% - 99%)*	440/449 = 98%(96% - 99%)*
OXY	140/141 = 99%(96% - 99%)*	306/309 = 99%(97% - 99%)*	446/450 = 99%(98% - 99%)*
PCP	85/86 = 99%(94% - 99%)*	300/304 = 99%(97% - 99%)*	385/390 = 99%(97% - 99%)*
PPX	145/146 > 99%(96% - 99%)*	304/304 > 99%(99% - 99%)**	449/450 > 99%(99% - 99%)*
TCA	32/32 > 99%(89% - 99%)**	316/338 = 93%(90% - 96%)*	348/370 = 94%(91% - 96%)*

Denotes 95% confidence interval.

** Since the proportion can not go above 100%, this is really a 97.5% confidence interval.

Conclusion:

Clinical study results demonstrate the substantial equivalency between the ACON multi-CLIN™ Drug Screen Test Device and the ACON Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants single tests, which have already being cleared by FDA and marketed in the United States. It is also demonstrated that these tests are safe and effective in detecting Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants at the following cut-off concentrations: Amphetamine 1,000 ng/mL, Barbiturates 300 ng/mL, Benzodiazepines 300 ng/mL, Cocaine 300 ng/mL, Marijuana 50 ng/mL, Methylenedioxymethamphetamine 500 ng/mL, Opiates 300 ng/mL, Oxycodone 100 ng/mL, Phencyclidine 25 ng/mL, Propoxyphene 300 ng/mL and Tricyclic Antidepressants 1,000 ng/mL. The physician's office laboratory POL study demonstrated that these tests are also suitable for use by professionals at point-of-care site.

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Image /page/5/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 tail feathers and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is facing to the right and appears to be in flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 3 0 2004

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

K041685 Re: K041063
Trade/Device Name: ACON multi-CLINTM Drug Screen Test Device Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Regulatory Class: Slass II
Product Code: DKZ, DIS, JXM, DIO, LDJ, LAF, DJG, LCM, JXN, LFG Dated: June 18, 2004 Received: June 22, 2004

Dear Dr. Tung:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced adove und nave acterimes ally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard) the enactment date of the Medical Device Amendments, or to Commerce prior to Harf 20, 1978, the same with the provisions of the Federal Food, Drug, devices mat have been roomstiled in quire approval of a premarket approval application (PMA). allu Cosmetic rece (11ct) that ac novice, subject to the general controls provisions of the Act. The r ou may, merelore, manov of the Act include requirements for annual registration, listing of general controls provisions of are tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is etassified (die as controls. Existing major regulations affecting your device it may be subject to bach adon and Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can oc found in Title announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be advisou that i Drivination that your device complies with other requirements of the Act that I DA has Intact to and regulations administered by other Federal agencies. You must of any I catal statutes and regarments, including, but not limited to: registration and listing (21 Comply with an the Ave brequirements, and good manufacturing practice CFR Part 807), labornial 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) This letter will and w you've begin and equivalence of your device of your device to a legally premarket notification: "The 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, If you destions on the promotion and advertising of your device, please contact the Office of or questions on the promotion 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 I bu may oouain outer gefacturers, 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 US, DVM.
MS, DVM

Tean 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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Indications for Use

510(k) Number (if known): K041685

Device Name: ACON multi-CLIN™ Drug Screen Test Device

Indications For Use:

The ACON multi-CLIN™ Drug Screen Test Device is a rapid chromatographic The ACON muni-SEN - Brag Soan simultaneous detection of Amphetamine, Inimunoassay Tor the qualitativo a.ra a.rijuana, Methylenedioxymethamphetamine, Barbiturates, Denzodiazopinos, Socano, Propoxyphene and Tricyclic Antidepressants in Oplates, Oxycodone, I nenoyalams, Froponyprofor these drugs are as follows: unne. The designatoa bat on biturates 300 ng/mL, Benzodiazepines 300 ng/mL, Amplietamine 1,000 ng/mL, Barbical col Methylenedioxymethamphetamine 500 Cocaine 300 ng/mL, Mahjuane Scooone 100 ng/mL, Phencyclidine 25 ng/mL, ng/mL, Oplatos Overg/mL and Tricyclic Antidepressants 1,000 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

This assay provides only a preliminary analytical test result. A more specific alternate This assay provides only a promininer to obtain a confirmed analytical result. Gas chemical must be acou in br & 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 used.

Prescription Use X ___________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

ffice of In Vitro Diagnostic Devices (OIVD) Concurrence of CDR

Division

Page 1 of 1

Office of In Vitro Diagnostic
Device Evaluation and Safety

5 K04163>

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).