The ImmuTest Multi-Drug Screen is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:

Test	Calibrator	Cut-off (ng/ml)
AMP	d-Amphetamine	1000
BAR	Secobarbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC 150	Benzoylecgonine	150
COC	Benzoylecgonine	300
MDMA	3,4-methylenedioxymethamphetamine	500
MET 500	d-Methamphetamine	500
MET	d-Methamphetamine	1000
MTD	dl-Methadone	300
OPI 300	Morphine	300
OPI	Morphine	2000
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-A9-THC-9-COOH	50

The ImmuTest Multi-Drug Screen consists of three test formats: card, cassette and cup. The configurations of the ImmuTest Multi-Drug Screen consist of any combination of the drugs listed above. The ImmuTest Multi-Drug Screen is used to obtain a visual, qualitative result and is intended for professional use only.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.

Device Description

The Ameditech ImmuTest Multi-Drug Screen is a lateral flow immunoassay intended for professional (prescription) use only. The device is used for the qualitative determination of parent compound and/or major metabolites of drugs in human urine specimens, and results are read visually. The device will be made available in three formats that use identical test strips: Dipcard, Cassette, and Cup. The modified device contains up to seventeen (17) assays that can include up to thirteen (13) different drugs at various cutoff concentrations. The assays detect different illicit drugs and medications that are commonly abused. Once the urine sample is administered, negative results can be read as soon as 1 minute and positive results should be read between 5 to 10 minutes. The presence of the line on the test region indicates a negative result for the drug and the absence of a line on the test region indicates a positive result for the drug. A visible line is also present at the control region of the test strip. This line should always appear, regardless of the presence of drugs or metabolites in the urine sample. This means that a negative urine sample will produce both a test line and control line, and a positive urine sample will generate only a control line. The presence of control line serves as a built-in control, which demonstrates that the test is performed properly.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study information for the Ameditech ImmuTest Multi-Drug Screen, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a Special 510(k) submission, meaning the device is substantially equivalent to a previously cleared predicate device. Therefore, the "acceptance criteria" are implicitly met by demonstrating equivalent performance to the predicate. The "reported device performance" is essentially the established performance of the predicate devices.

Table 1: Acceptance Criteria (Referencing Predicate Performance) and Reported Device Performance

Performance Characteristic	Acceptance Criteria (from Predicate Device)	Reported Device Performance (Modified Device)
Precision (Reproducibility)	Established and validated in predicate submissions	Equivalent to predicate (confirmed by analytical performance verification testing)
Analytical Specificity	Established and validated in predicate submissions	Equivalent to predicate (confirmed by analytical performance verification testing)
Interfering Substances	Established and validated in predicate submissions	Equivalent to predicate (confirmed by analytical performance verification testing)
Qualitative Detection (Cut-off Concentrations)	Specific cut-off concentrations for various drugs as defined for predicate	Identical cut-off concentrations for various drugs as per predicate
Visual Result Readability	Established in predicate submissions	Assumed equivalent due to identical test strips
Built-in Control Functionality	Established in predicate submissions	Assumed equivalent due to identical test strips

Study Details

Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states that no clinical studies were conducted for this special 510(k) submission because the modified and predicate devices use identical test strips. Therefore, there is no new test set with specific sample sizes for this submission. The performance characteristics validated in the predicate submissions are considered applicable. The original provenance of data for predicate devices is not specified in this document.
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 clinical or performance studies were conducted for this submission. The ground truth (drug presence/absence and concentration) for the predicate device studies would have been established through methods like GC/MS or LC/MS, but the specific number and qualifications of experts involved in those prior studies are not detailed here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no new clinical or performance studies were conducted for this submission.
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 manual, visually-read immunoassay for drug detection and does not involve AI or human-in-the-loop performance in the context of diagnostic imaging or similar applications where MRMC studies are common.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a visually-read immunoassay and does not have a "standalone algorithm" in the typical sense of AI/image analysis. Its performance is inherent to the chemical reaction on the test strip and the visual interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the predicate devices (and hence assumed for this modified device), the ground truth for drug presence and concentration in urine samples would have been established through more specific alternate chemical methods, primarily Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS). These are stated as the preferred confirmation methods for preliminary positive results.
The sample size for the training set
- Not applicable. This device is a chemical immunoassay, not a machine learning model that requires a training set.
How the ground truth for the training set was established
- Not applicable for the reason stated above.

Summary

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NOV 10 2011

NIRS
Total Multi-Purpose Sensor

ImmuTest Multi-Drug Sc

510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92 and follows the Device Advice Guidance concerning "How To Prepare A Special 510(k)"

Submitter: A.

Submitter:	Ameditech, Inc.10340 Camino Santa Fe.San Diego, CA 92121
Contact Person:	Greg CerraSenior Manager, Regulatory AffairPhone: 858.805.3036Fax: 858.805.7100Email: gregory.cerra@alere.com
Date prepared:	October 12, 2011

Device Names: B.

Ameditech ImmuTest Multi-Drug Screen Dipcard Ameditech ImmuTest Multi-Drug Screen Cassette Ameditech ImmuTest Multi-Drug Screen Cup

Predicates:

Ameditech ImmuTest Multi-Drug Screen Panel III (K050186)

C. Device Description:

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D. Intended Use:

The ImmuTest Multi-Drug Screen is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:

Test	Calibrator	Cut-off (ng/ml)
AMP	d-Amphetamine	1000
BAR	Secobarbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC 150	Benzoylecgonine	150
COC	Benzoylecgonine	300
MDMA	3,4-methylenedioxymethamphetamine	500
MET 500	d-Methamphetamine	500
MET	d-Methamphetamine	1000
MTD	dl-Methadone	300
OPI 300	Morphine	300
OPI	Morphine	2000
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-A9-THC-9-COOH	50

Comparison with the Predicate ن

The modified device is identical to the cleared predicates referenced above (K050186). The drug strips cleared by FDA in submissions K040092, K042975, and K063015 will be consolidated into a single device. The purpose of this submission is to cover all the drug strips and their respective cutoffs with a single 510(k) clearance. See Section 12.2 of this submission for a detailed comparison of the modified device with the predicates.

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F. Nonclinical Data:

As the test strips in both the modified and predicate devices are identical in terms of intended use, test principle, manufacturing process, and raw materials; simplified performance studies were conducted to demonstrate that the sensitivity, precision, and specificity of the modified device was unchanged from the predicate devices. The analytical performance verification testing confirms that the Ameditech ImmuTest Multi-Drug Screen has equivalent performance compared with the predicate devices in terms of precision (reproducibility), analytical specificity, analytical specificity, and interfering substances.

G. Clinical Data:

Both the modified and predicate devices use identical test strips, therefore we did not conduct any clinical studies for this special 510(k) submission, because the performance characteristics that were validated in the predicate submissions are applicable to the modified device.

H. Conclusions Drawn from Testing Results:

Performance verification and validation studies have demonstrated that the device is as safe, as effective, and performs as well or better than the predicate device.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing or protecting another figure, which is a common symbol associated with the department.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Ameditech, Inc. c/o Mr. Greg Cerra Senior Manager, Regulatory Affairs 10340 Camino Santa FE, Suite F San Diego, California 92121

NOV 1 0 2011

Re: K113046 Trade Name: Ameditech Immutest Milti-Drug Screen . Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system. Regulatory Class II Product Codes: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM, JXN, LAF Dated: October 13, 2011 Received: October 13, 2011

Dear Mr. Cerra:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR Part 80% 97%. For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding of any of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/de('ault.htm.

Sincerely yours.

Courtney H. Lias, Ph.D. 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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Ameditech, Inc.

Indications for Use Statement

510(k) Number (if known):

Device Name: ImmuTest Multi-Drug Screen

Indications for Use:

The ImmuTest Multi-Drug Screen is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:

Test	Calibrator	Cut-off (ng/ml)
AMP	d-Amphetamine	1000
BAR	Secobarbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC 150	Benzoylecgonine	150
COC	Benzoylecgonine	300
MDMA	3,4-methylenedioxymethamphetamine	500
MET 500	d-Methamphetamine	500
MET	d-Methamphetamine	1000
MTD	dl-Methadone	300
OPI 300	Morphine	300
OPI	Morphine	2000
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-A9-THC-9-COOH	50

The ImmuTest Multi-Drug Screen consists of three test formats: card, cassette and cup. The configurations of the ImmuTest Multi-Drug Screen consist of any combination of the drugs isted above. The ImmuTest Multi-Drug Screen is used to obtain a visual, qualitative result and is intended for professional use only.

Prescription Use______________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801, Subpart D) AND/OR

Over-the-Counter Use (Part 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)

Ruth Chalon

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k):

Page 1 of 1

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).