K Number

Device Name

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup

Manufacturer

ANHUI Deepblue Medical Technological Co., Ltd.

Date Cleared

2025-04-15

(29 days)

Product Code

NGL NFT NFV NFW NFY NGG NGM PTG PTH QAW QBF

Regulation Number

862.3650

Intended Use

The Deepblue Multi-Drug Urine Test Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, fentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Test | Calibrator | Cut-off(ng/mL) ---|---|--- 6-MAM | 6-Monoacetylmorphine | 10 AMP | d-Amphetamine | 500 or 1000 BAR | Secobarbital | 300 BUP | Buprenorphine | 10 BZO | Oxazepam | 300 COC | Benzoylecgonine | 150 or 300 EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine | 300 FYL | Fentanyl | 1 MDMA | Methylenedioxymethamphetamine | 500 MET | d-Methamphetamine | 500 or 1000 MTD | d/l-Methadone | 300 MOP/OPI | Morphine | 300 or 2000 OXY | Oxycodone | 100 PCP | Phencyclidine | 25 PPX | d-Propoxyphene | 300 TCA | Nortriptyline | 1000 THC | 11-nor-Δ9-THC-COOH | 50 The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT). The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. The Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs. Code | Substance | Cut-off(ng/mL) ---|---|--- AMP | Amphetamine | 1000 or 500 BUP | Buprenorphine | 10 BAR | Secobarbital | 300 BZO | Oxazepam | 300 COC | Cocaine | 300 or 150 EDDP | EDDP | 300 FYL | Fentanyl | 1 MET | Methamphetamine | 1000 or 500 MDMA | Ecstasy | 500 OPI | Morphine | 2000 or 300 MTD | Methadone | 300 OXY | Oxycodone | 100 PCP | Phencyclidine | 25 PPX | Propoxyphene | 300 TCA | Nortriptyline | 1000 THC | Marijuana | 50 6-MAM | 6-Monoacetylmorphine | 10 This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Device Description

Deepblue Home Muti-Drug Urine Test Cup and Deepblue Muti-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K240686

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a rapid lateral flow immunoassay device, which uses chemical reactions to detect substances. There is no mention of AI, machine learning, or any computational model being used within the device for its operation or result interpretation.

Therapeutic

No
This device is a diagnostic tool used to detect the presence of certain substances in urine, not to treat a medical condition.

Diagnostic

Yes.

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is for "qualitative detection" of various substances in human urine, and while it provides "preliminary results," it is clearly designed to identify the presence or absence of specific analytes to inform further action, which is a diagnostic function. The performance studies also detail its analytical capabilities in detecting these substances.

SaMD (Software as a Medical Device)

This device is a physical diagnostic test cup (an "immunochromatographic assay that uses a lateral flow system") designed to detect drugs in urine. It is a hardware medical device, not a software-only medical device.

IVD (In Vitro Diagnostic)

Yes.
The device is described as an "immunoassay for the qualitative detection of ... in human urine," "immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine." This indicates it is used to examine specimens derived from the human body to provide information for diagnostic purposes, which aligns with the definition of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Test	Calibrator	Cut-off(ng/mL)
6-MAM	6-Monoacetylmorphine	10
AMP	d-Amphetamine	500 or 1000
BAR	Secobarbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	150 or 300
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine	300
FYL	Fentanyl	1
MDMA	Methylenedioxymethamphetamine	500
MET	d-Methamphetamine	500 or 1000
MTD	d/l-Methadone	300
MOP/OPI	Morphine	300 or 2000
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	d-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-Δ9-THC-COOH	50

The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs.

Code	Substance	Cut-off(ng/mL)
AMP	Amphetamine	1000 or 500
BUP	Buprenorphine	10
BAR	Secobarbital	300
BZO	Oxazepam	300
COC	Cocaine	300 or 150
EDDP	EDDP	300
FYL	Fentanyl	1
MET	Methamphetamine	1000 or 500
MDMA	Ecstasy	500
OPI	Morphine	2000 or 300
MTD	Methadone	300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	Marijuana	50
6-MAM	6-Monoacetylmorphine	10

This drug test cup may contain any combination of the drug tests listed in the table above.

This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Product codes (comma separated list FDA assigned to the subject device)

NGL, PTH, NFT, NFV, NFY, PTG, NGG, NGM, QBF, QAW, NFW

Device Description

The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Method comparison study:
The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results.

Lay person study:
A lay user study was performed at three intended user sites with 280 lay persons. 176 male and 104 female participated the study. They had diverse educational and professional backgrounds and their age range from 21 to > 50. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC-MS/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A. Analytical performance
a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. Results summarized in tables for each drug and lot.

b. Linearity/assay reportable range:
Not applicable. This device is intended for qualitative use only.

c. Stability:
The device is stable at 2-30℃ for 24 months based on real time stability study.

d. Analytical specificity/Interference:
To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of the device. Percent cross-reactivity tables provided for each drug, showing minimum concentration for positive result and % cross-reactivity.
Interference by non-structurally related compounds were tested at 100µg/mL based on a large table.
Interference by pH and specific gravity were also evaluated using pooled urine specimens with concentrations of 0 (drug-free), at 50% below and 50% above each corresponding cutoff. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.

B. Method comparison study
Performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. Samples were blind labeled and compared to LC-MS/MS results. Results are presented in tables per drug and operator, showing number of positive/negative results across different concentration ranges: Drug-Free, Low Negative, Near Cutoff Negative, Near Cutoff Positive, and High Positive. Discordant results are summarized, showing sample number, LC/MS/MS result (ng/mL), and stated accurate result.

C. Lay person study
280 lay persons (176 male, 104 female) aged 21 to >50 participated. Urine samples at -100%, +/-75%, +/-50%, +/-25% of cutoff were used. LC-MS/MS confirmed concentrations. Each participant received one blind-labeled sample and a device. Results summarized in agreement tables for each drug and concentration, showing number of Negative/Positive results and Agreement (%). Participants indicated instructions were easy to understand. Flesch-Kincaid reading analysis showed a Grade Level of 7 for the package insert.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Key metrics are presented in the precision study tables (number of negative/positive results for specific concentrations relative to cutoff), and the method comparison study tables (test results compared to LC-MS/MS for different concentration ranges). For the lay person study, "Agreement (%)" is provided. Explicit sensitivity, specificity, PPV, NPV values are not directly calculated or presented as aggregated statistics.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Healgen Accurate Urine Drug Screen Dip Card (K240686)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).

Summary

FDA 510(k) Clearance Letter - K250803

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 15, 2025

ANHUI Deepblue Medical Technological Co., Ltd.
℅ Jenny Xia
Director
LSI International, Inc.
504 East Diamond Ave, Suite H
Gaithersburg, Maryland 20877

Re: K250803
Trade/Device Name: Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
Regulation Number: 21 CFR 862.3650
Regulation Name: Opiate test system
Regulatory Class: Class II
Product Code: NGL, PTH, NFT, NFV, NFY, PTG, NGG, NGM, QBF, QAW, NFW
Dated: March 16, 2025
Received: March 17, 2025

Dear Jenny Xia:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Page 2

K250803 - Jenny Xia Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

Page 3

K250803 - Jenny Xia Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

JOSEPH A. KOTAREK -S
Digitally signed by JOSEPH A. KOTAREK -S
Date: 2025.04.15 15:16:37 -04'00'

Joseph Kotarek
Branch Chief for Toxicology
Division of Chemistry and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (8/23) Page 1 of 2

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K250803

Device Name: Deepblue Multi-Drug Urine Test Cup; Deepblue Home Multi-Drug Urine Test Cup

Indications for Use (Describe)

Test	Calibrator	Cut-off(ng/mL)
6-MAM	6-Monoacetylmorphine	10
AMP	d-Amphetamine	500 or 1000
BAR	Secobarbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	150 or 300
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine	300
FYL	Fentanyl	1
MDMA	Methylenedioxymethamphetamine	500
MET	d-Methamphetamine	500 or 1000
MTD	d/l-Methadone	300
MOP/OPI	Morphine	300 or 2000
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	d-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-Δ9-THC-COOH	50

The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

The Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs.

Code	Substance	Cut-off(ng/mL)
AMP	Amphetamine	1000 or 500
BUP	Buprenorphine	10
BAR	Secobarbital	300
BZO	Oxazepam	300
COC	Cocaine	300 or 150
EDDP	EDDP	300

Page 5

FORM FDA 3881 (8/23) Page 2 of 2

FYL	Fentanyl	1
MET	Methamphetamine	1000 or 500
MDMA	Ecstasy	500
OPI	Morphine	2000 or 300
MTD	Methadone	300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	Marijuana	50
6-MAM	6-Monoacetylmorphine	10

This drug test cup may contain any combination of the drug tests listed in the table above.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 6

510(k) SUMMARY

K250803

Date: March 9, 2025
Submitter: ANHUI Deepblue Medical Technological Co., Ltd.
Pearl Industrial Park, 106 Innovation Ave.
Hefei, Anhui 230088
China
Contact person: Jenny Xia
LSI International Inc.
504 East Diamond Ave., Suite H
Gaithersburg, MD 20877
Telephone: 301-525-6856
Email: jxia@lsi-consulting.org
Device Name: Deepblue Multi-Drug Urine Test Cup
Deepblue Home Muti-Drug Urine Test Cup
Classification: Class II

Product Code	Target Drug	Regulation Section	Panel
NFT	Amphetamine (AMP)	862.3100, Amphetamine Test System	Toxicology
PTH	Secobarbital (BAR)	862.3150, Barbiturate Test System	Toxicology
NGL	Buprenorphine (BUP)
Morphine (OPI)
Oxycodone (OXY)
6-Monoacetylmorphine(6-MAM)
Fentanyl (FEN)	862.3650, Opiate Test System	Toxicology
NFV	Oxazepam (BZO)	862.3170, Benzodiazepine Test System	Toxicology
NFY	Cocaine (COC)	862.3250, Cocaine and cocaine metabolite test system	Toxicology
PTG	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)
Methadone (MTD)	862.3620, Methadone Test System	Toxicology
NGG	Methylenedioxymethamphetamine (MDMA)
Methamphetamine (MET)	862.3610, Methamphetamine Test System	Toxicology
NGM		Unclassified	Toxicology

Page 7

Phencyclidine (PCP)
QBF	Propoxyphene(PPX)	862.3700 Propoxyphene test system.
QAW	Nortriptyline (TCA)	862.3910 Tricyclic antidepressant drugs test system
NFW	Cannabinoids (THC 50)	862.3870, Cannabinoids Test System

Predicate Devices:
Healgen Accurate Urine Drug Screen Dip Card (K240686)
Intended Use

Test	Calibrator	Cut-off (ng/mL)
6-MAM	6-Monoacetylmorphine	10
AMP	d-Amphetamine	500 / 1000
BAR	Secobarbital	300
BUP	Buprenorphine	10
BZO	Oxazepam	300
COC	Benzoylecgonine	150 / 300
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine	300
FYL	Fentanyl	1
MDMA	Methylenedioxymethamphetamine	500
MET	d-Methamphetamine	500 / 1000
MTD	d/l-Methadone	300
OPI	Morphine	300 / 2000
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	d-Propoxyphene	300
TCA	Nortriptyline	1000
THC	11-nor-∆9-THC-COOH	50

The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

Page 8

spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay.

The device provides preliminary results for the detection of one or more of the following drugs.

CODE	SUBSTANCE	CUT-OFF (ng/mL)
AMP	Amphetamine	1000 or 500
BUP	Buprenorphine	10
BAR	Secobarbital	300
BZO	Oxazepam	300
COC	Cocaine	300 or 150
EDDP	EDDP	300
FYL	Fentanyl	1
MET	Methamphetamine	1000 or 500
MDMA	Ecstasy	500
OPI	Morphine	2000 or 300
MTD	Methadone	300
OXY	Oxycodone	100
PCP	Phencyclidine	25
PPX	Propoxyphene	300
TCA	Nortriptyline	1000
THC	Marijuana	50
6-MAM	6-Monoacetylmorphine	10

This drug test cup may contain any combination of the drug tests listed in the table above.

Device Description

The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

Substantial Equivalence Information

Page 9

Similarities

Item	Device	Predicate (K240686)
Intended use	Qualitative detection of drugs of abuse in urine. For prescription use or over-the-counter use	Same.
Methodology	Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction	Same
Type of Test	Qualitative	Same
Specimen Type	Human urine	Same
Target Drug and Cut Off Values	Target Drugs - Cutoff (ng/mL)
Amphetamine(AMP) - 1000 or 500
Secobarbital (BAR) - 300
Buprenorphine (BUP) - 10
Oxazepam (BZO) - 300
Cocaine (COC) - 300 or 150
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) - 300
Fentanyl - 1
Methylenedioxymethamphetamine (MDMA) - 500
Methamphetamine (MET) - 1000 or 500
Morphine (MOP300/OPI2000) - 2000 or 300
Methadone (MTD) - 300
Oxycodone (OXY) - 100
Phencyclidine (PCP) - 25
Propoxyphene(PPX) - 300
Nortriptyline (TCA) - 1000
Cannabinoids (THC) - 50
6-Monoacetylmorphine(6-MAM) - 10	Same except no Fentanyl

Differences

Configurations	Test cup	Test Dip Card

Page 10

Standard/Guidance Document Reference (if applicable)
None referenced.
Test Principle

Deepblue Home Muti-Drug Urine Test Cup or Deepblue Muti-Drug Urine Test Cup is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody conjugate binding sites.

When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.

When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.

To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.

Performance Characteristics

A. Analytical performance

a. Precision/Reproducibility:

Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the following tables:

Drug	Lot Number	+100% cutoff	+75% cutoff	+50% cutoff	+25% cutoff	Cutoff	-25% cutoff	-50% cutoff	-75% cutoff	-100% cut-off
AMP 1000	Lot 1	0-/50+	0-/50+	0-/50+	3-/47+	8-/42+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	4-/46+	11-/39+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	7-/43+	48-/2+	50-/0+	50-/0+	50-/0+
BAR 300	Lot 1	0-/50+	0-/50+	0-/50+	4--/46+	17-/33+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	3-/47+	14-/36+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	3-/47+	15-/35+	48-/2+	50-/0+	50-/0+	50-/0+

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BUP 10	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	19-/31+	46-/4+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	18-/32+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	3-/47+	18-/32+	47-/3+	50-/0+	50-/0+	50-/0+
BZO 300	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	15-/35+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	3-/47+	16-/34+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	3-/47+	14-/36+	47-/3+	50-/0+	50-/0+	50-/0+
COC 300	Lot 1	0-/50+	0-/50+	0-/50+	3-/47+	9-/41+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	8-/42+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	12-/38+	49-/1+	50-/0+	50-/0+	50-/0+
EDDP 300	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	10-/40+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	10-/40+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	3-/47+	10-/40+	47-/3+	50-/0+	50-/0+	50-/0+
FYL 1	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	18-/32+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	4-/46+	20-/30+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	3-/47+	18-/32+	46-/4+	50-/0+	50-/0+	50-/0+
MDMA 500	Lot 1	0-/50+	0-/50+	0-/50+	3-/47+	12-/38+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	3-/47+	14-/36+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	15-/35+	48-/2+	50-/0+	50-/0+	50-/0+
MET 1000	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	10-/40+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	8-/42+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	7-/43+	48-/2+	50-/0+	50-/0+	50-/0+
MOP 300	Lot 1	0-/50+	0-/50+	0-/50+	4-/46+	10-/40+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	3-/47+	12-/38+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	3-/47+	13-/37+	48-/2+	50-/0+	50-/0+	50-/0+
MTD 300	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	17-/33+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	19-/31+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	3-/47+	20-/30+	47-/3+	50-/0+	50-/0+	50-/0+
OXY 100	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	10-/40+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	1-/49+	9-/41+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	10-/40+	47-/3+	50-/0+	50-/0+	50-/0+
PCP 25	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	17-/33+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	3-/47+	20-/30+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	18-/32+	48-/2+	50-/0+	50-/0+	50-/0+
PPX 300	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	22-/28+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	24-/26+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	23-/27+	47-/3+	50-/0+	50-/0+	50-/0+
TCA 1000	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	20-/30+	46-/4+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	3-/47+	18-/32+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	21-/29+	47-/3+	50-/0+	50-/0+	50-/0+
THC 50	Lot 1	0-/50+	0-/50+	0-/50+	3-/47+	24-/26+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	4-/46+	26-/24+	49-/1+	50-/0+	50-/0+	50-/0+

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	Lot 3	0-/50+	0-/50+	0-/50+	4-/46+	22-/28+	48-/2+	50-/0+	50-/0+	50-/0+
6-MAM 10	Lot 1	0-/50+	0-/50+	0-/50+	3-/47+	11-/39+	46-/4+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	3-/47+	14-/36+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	9-/41+	48-/2+	50-/0+	50-/0+	50-/0+
AMP 500	Lot 1	0-/50+	0-/50+	0-/50+	2-/48+	11-/39+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	3--/47+	12-/38+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	11-/39+	47-/3+	50-/0+	50-/0+	50-/0+
COC 150	Lot 1	0-/50+	0-/50+	0-/50+	3-/47+	12-/38+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	2-/48+	14-/36+	46-/4+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	3-/47+	10-/40+	48-/2+	50-/0+	50-/0+	50-/0+
MET 500	Lot 1	0-/50+	0-/50+	0-/50+	3-/47+	9-/41+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	4-/46+	10-/40+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	2-/48+	8-/42+	48-/2+	50-/0+	50-/0+	50-/0+
OPI 2000	Lot 1	0-/50+	0-/50+	0-/50+	3-/47+	12-/38+	48-/2+	50-/0+	50-/0+	50-/0+
	Lot 2	0-/50+	0-/50+	0-/50+	3-/47+	14-/36+	47-/3+	50-/0+	50-/0+	50-/0+
	Lot 3	0-/50+	0-/50+	0-/50+	4-/46+	15-/35+	47-/3+	50-/0+	50-/0+	50-/0+

b. Linearity/assay reportable range:

Not applicable. This device is intended for qualitative use only.

c. Stability:

The device is stable at 2-30℃ for 24 months based on real time stability study.

d. Analytical specificity/Interference:

To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of the device.

Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100. If no cross-reactivity was observed, the highest concentration tested is shown.

Drug/Cutoff	Compound	Minimum concentration required to obtain a positive result (ng/mL)	% Cross-Reactivity
AMP 1000	Hydroxyamphetamine	8000	12.5%
	(+/-)-Methylenedioxyamphetamine (MDA)	10000	10%
	D,L-Amphetamine	1,000	100%
	D-Amphetamine	1,000	100%
	Diethylstilbestrol	>100000	100000

Result of Deepblue Muti-Drug Urine Test Cup Configuration 1:

Page 32

	Positive	0	0	0	1	19	20	20
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
BUP	10	Negative	20	20	20	18	1	0
		Positive	0	0	0	2	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%
BZO	300	Negative	20	20	20	18	1	0
		Positive	0	0	0	2	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%
COC	150	Negative	20	20	20	19	1	0
		Positive	0	0	0	1	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%
EDDP	300	Negative	20	20	20	18	1	0
		Positive	0	0	0	2	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%
FTY	1	Negative	20	20	20	19	2	0
		Positive	0	0	0	1	18	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%
MDMA	500	Negative	20	20	20	19	0	0
		Positive	0	0	0	1	20	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	100%	100%
MET	500	Negative	20	20	20	18	1	0
		Positive	0	0	0	2	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%
MOP	300	Negative	20	20	20	20	1	0
		Positive	0	0	0	0	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95%	100%
MTD	300	Negative	20	20	20	19	1	0
		Positive	0	0	0	1	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%
OXY	100	Negative	20	20	20	19	1	0
		Positive	0	0	0	1	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%

Page 33

PCP	25	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
PPX	300	Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
TCA	1000	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
THC	50	Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
6-MAM	10	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%

Result of Deepblue Muti-Drug Urine Test Cup Configuration 2:

| Drug | Cutoff (ng/mL) | Results | Concentration |||||||
|------|----------------|---------|-------------|
| | | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| AMP | 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| BUP | 10 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| BZO | 300 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| COC | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |

Page 34

	Positive	0	0	0	1	19	20	20
	Total	20	20	20	20	20	20	20
	Agreement (%)	100%	100%	100%	95%	95%	100%	100%
EDDP	300	Negative	20	20	20	19	1	0
		Positive	0	0	0	1	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%
FTY	1	Negative	20	20	20	19	1	0
		Positive	0	0	0	1	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%
MDMA	500	Negative	20	20	20	18	1	0
		Positive	0	0	0	2	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%
MET	1000	Negative	20	20	20	20	1	0
		Positive	0	0	0	0	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	100%	95%	100%
MOP	2000	Negative	20	20	20	19	0	0
		Positive	0	0	0	1	20	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	100%	100%
MTD	300	Negative	20	20	20	19	1	0
		Positive	0	0	0	1	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%
OXY	100	Negative	20	20	20	19	1	0
		Positive	0	0	0	1	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%
PCP	25	Negative	20	20	20	19	2	0
		Positive	0	0	0	1	18	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%
PPX	300	Negative	20	20	20	18	1	0
		Positive	0	0	0	2	19	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%
TCA	1000	Negative	20	20	20	19	2	0
		Positive	0	0	0	1	18	20
		Total	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%

Page 35

THC	50	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
6-MAM	10	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%

Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

Clinical Studies:
Not applicable.

Conclusion

Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that Deepblue Home Muti-Drug Urine Test Cup and Deepblue Muti-Drug Urine Test Cup are substantially equivalent to the predicate devices.