The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic one-step in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 300/2000 ng/ml; oxycodone, 100 ng/ml and phencyclidine, 25 ng/ml. Only one cutoff concentration will be included per analyte per device.

The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMSHA). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Device Description

The Rapid Diagnostics MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup are competitive binding, lateral flow immunochromatographic iv-vitro assays for the qualitative and simultaneous detection of amphetamines, barbiturates, benzodiazenines, buprenorphine, cocaine, methadone, methamphetamine, opiates, oxycodone and phencyclidine, in human urine samples. MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup detects each of the analytes on separate strips. A positive urine sample will not generate a colored line for the specific drug tested in the designated region. A negative urine sample containine, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine, methamphetamine, opiates, oxycodone or phencyclidine below the designated cutoff 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.

AI/ML Overview

The provided document describes the MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup, which are in-vitro immunochromatographic assays for drug detection in human urine. Here's a breakdown of the acceptance criteria and the study details:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for performance were based on a comparison study to verify that there is no performance difference between the DOA Test Strips and DOA Test Cups when exposed to a human urine specimen for 20 seconds vs. 5 minutes. The specific acceptance criteria are implied by the reported results:

Device Format	Number of Tests	Number Passed	Acceptance Rate
DOA Test Strips	432	432	100%
MP DOA-10 Panel Test Cups	360	360	100%
MP DOA-11 Panel Test Cups	396	396	100%

Note: The document states "per the pre-defined study acceptance criteria" but does not explicitly list the criteria themselves. However, the 100% pass rate implies that the devices met the full performance expectations in this comparison study.

An additional study on interfering drug analytes also demonstrated no interference at 5 and 10 minutes following the addition of specimens at different concentrations.

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

Since this document describes a pre-market notification (510k), it refers to validation studies rather than external test sets in the typical AI/ML context.

Comparison Study:
- For each device format (DOA Test Strips, MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup), three lots of product were tested.
- Each lot was tested over three drug cut-off concentration levels (-50%, +50%, +300%), including a negative specimen.
- Total tests: 432 for DOA Test Strips, 360 for MP DOA-10 Panel Test Cups, and 396 for MP DOA-11 Panel Test Cups.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective, but given it's a device for use with "human urine," it's prospective data collected from prepared samples for internal validation.
Interfering Drug Analyte Study:
- 198 MP DOA-11 Panel Test Cups (divided into 2 groups) were used.
- 180 MP DOA-10 Panel Test Cups (divided into 2 groups) were used.
- Tested over 3 lots of DOA Test Cups.
- Cut-off concentrations (-50%, +50%, +300%) for each drug analyte were assessed.
- Data Provenance: Similar to the comparison study, this would likely be prospective data collected from controlled laboratory settings.

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

This type of device (immunochromatographic in-vitro test) does not typically involve human experts in the way an AI diagnostic imaging device would. The "ground truth" for the test set (urine samples with specific drug concentrations) is established through precise laboratory preparation of known concentrations of drug substances and negative specimens.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. The results are based on a chemical reaction producing a visible line, not subjective interpretations requiring adjudication.

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 is not an AI-based device that assists human readers. It's a standalone in-vitro diagnostic test.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance evaluations of the device itself. The device (test cup) functions without continuous human intervention to interpret the chemical reaction. While a human reads the result (presence or absence of a line), the detection mechanism is entirely within the device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is based on known, controlled concentrations of drug analytes in urine samples prepared in a laboratory setting. For example, samples were prepared at -50%, at cut-off, +50%, and +300% of the specified cut-off levels for each drug. Negative control samples were also used.

8. The Sample Size for the Training Set

This document describes a medical device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The device's operational characteristics are determined by its chemical and physical design, which is developed and refined, but not "trained" with data like a machine learning model.

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

Not applicable. There is no training set as this is not an AI/ML device. The performance is based on the inherent chemical and immunological properties of the test strips and cups.

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2017

MP Biomedicals, LLC Sean R. Gemmill, MS. RAC Director of Regulatory Affairs 1429 Rollins Road Burlingame, California 94010

Re: K162395

Trade/Device Name: MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO, DIS, DJG, DJR, DKZ, JXM, LAF, LCM, LDJ Dated: May 9, 2017 Received: May 10, 2017

Dear Mr. Gemmill:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162395

Device Name MP DOA-10 Panel Test Cup MP DOA-11 Panel Test Cup

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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510(k) Summary

This summary of 510(k) safety and effectiveness is submitted in accordance with 21 CFR 807.92.

The assigned 510(k) number is: K162395

1. Date:	May 24, 2017
2. Submitter:	Rapid DiagnosticsDivision of MP Biomedicals, LLC1429 Rollins RoadBurlingame, CA 94010 USATel: (650) 558-0395FAX: (650) 558-0397
3. Contact Person:	Sean Gemmill, MS, RAC,Director of Regulatory AffairsMP Biomedicals, LLC3 Hutton Centre Dr. #100Santa Ana, CA 92707Tel: (949) 833-2500FAX: (949) 859-5010
4. Establishment Registration #:	2954282
5. Device Name:Common Name:Trade or Proprietary Name:	Multi Drugs of Abuse Test CupMP DOA-10 Panel Test CupMP DOA-11 Panel Test Cup

1. Classification:
  Class II medical as defined by FDA product codes and the Code of Federal Regulations (CFRs):

ProductCode	Regulatory Description	DeviceClass	RegulationSection	Review Panel
DKZ	Amphetamine test system	II	862.3100	Toxicology (91)
DIS	Barbiturate test system	II	862.3150	Toxicology (91)
JXM	Benzodiazepine test system	II	862.3170	Toxicology (91)
LDJ	Cannabinoid test system	II	862.3870	Toxicology (91)
DIO	Cocaine and cocaine metabolite testsystem	II	862.3250	Toxicology (91)
DJR	Methadone test system	II	862.3620	Toxicology (91)
LAF	Methamphetamine test system	II	862.3610	Toxicology (91)
LCM	Amphetamine test system,Phencyclidine	II	862.3100	Toxicology (91)
DJG	Opiate test system	II	862.3650	Toxicology (91)

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7. Description of the Device:

Drug Identifier	Cut-off Level (ng/ml)
Amphetamine (AMP)	1000
Barbiturates (BAR)	300
Benzodiazepine (BZD)	300
Buprenorphine (BUP)	10
Cannabinoids (THC)	50
Cocaine (COC)	300
Methadone (MTD)	300
Methamphetamine (MAMP)	1000
Opiates	300
Opiates II	2000
Oxycodone (OXY)	100
Phencyclidine (PCP)	25

Configurations of the MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup can consist of any combination of up to 10 or 11 drug analyte test strips respectively, depending on the cup size. The test provides only preliminary test results and a more specific alternative chemical method must be used in order to obtain a confirmed analytical results. GC/MS is the preferred confirmatory method.

8. Indications for Use

The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic onestep in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml.; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 300/2000 ng/ml; oxycodone, 100 ng/ml and phencyclidine, 25 ng/ml. Only one cutoff concentration will be included per analyte per device.

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9. Predicate Devices

The following 510(k) cleared devices belong to Rapid Diagnostics; Rapid Drugs of Abuse Single and Multiple Test Panels (K003809), MICROMEDIC Drugs of Abuse Panel Test (K033566) and RapidBUP Test Strip / RapidOXY Test Strip (K051958). These previously cleared drugs of abuse test strip and drugs of abuse test panels are predicate devices to the MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cups of this Pre-Market Notification.

10. Substantial Equivalence Information

The MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup are a "modified" product format derived from previously FDA cleared single and multi-panel DOA tests. The modification of the subject device, MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup offers the previously 510(k) cleared drugs of abuse tests in a test cup format. The following 510(k) cleared devices; Rapid Drugs of Abuse Single and Multiple Test Panels (K003809), MICROMEDIC Drugs of Abuse Panel Test (K033566) and RapidBUP Test Strip/RapidOXY Test Strip (K051958), to which substantial equivalence is claimed, belong to Rapid Diagnostics. The subject devices in its modified format of this submission are substantially equivalent to the previously cleared Rapid Diagnostics drugs of abuse tests.

11. Performance

A comparison study was conducted to verify that there is no performance difference of the DOA Test Strips and DOA Test Cups when exposed to a human urine specimen for 20 seconds vs. 5 minutes. For each device format, three lots of product were tested over three drug cut-off concentration levels (-50%, + 50%, +300%) including a negative specimen. Testing was conducted utilizing three device formats; DOA Test Strips, DOA-10 Panel Test Cup and DOA-11 Panel Test Cups. During the conduct of this comparison study there were no observed test failures. 432/432 of the drug test strips passed, 360/360 of the MP DOA-10 Panel Test Cups passed and 396/396 of the MP DOA-11 Panel Test Cups passed per the pre-defined study acceptance criteria. An interfering drug analyte study was conducted using 198 MP DOA-11 Panel Test Cups (divided in 2 groups) and 180 MP DOA-10 Panel Test Cups (divided in 2 groups) over 3 lots of DOA Test Cups. Cut-off concentrations (-50%, +50%, +300%) for each drug analyte were assessed for interference. Following the addition of specimen at the 3 different concentrations, results at 5 and 10 minutes demonstrated no interference. Additional performance data of precision, reproducibility, interference, sensitivity and specific analytes and test devices were reported in previously cleared 510(k) Pre-Market Notifications belonging to Rapid Diagnostics as outlined in the following table:

Rapid Diagnostics Drugs of Abuse Tests - Performance Data References
Drug Identifier	Cut-off Level (ng/ml)	510(k) Reference
Amphetamine	1000	K033566, K003809
Barbiturates (secobarbital)	300	K033566, K030211
Benzodiazepine (oxezepam)	300	K033566, K003809
Buprenorphine	10	K051958
Cannabinoids	50	K033566, K003809
Cocaine	300	K033566, K003809
Methadone	300	K033566, K023252
Methamphetamine	1000	K033566, K003809
Opiates	300	K033566, K003809
Opiates II	2000	K033566, K020716
Oxycodone	100	K051958
Phencyclidine	25	K033566, K003809

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).