Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard immunochromatographic assay (lateral flow test) for qualitative detection of drugs in urine. There is no mention of AI, ML, image processing, or any computational analysis of the results. The interpretation is based on visual detection of lines.

Therapeutic

No
Explanation: This device is an in-vitro diagnostic device used to detect the presence of various drugs in urine; it does not treat or alleviate any condition or disease.

Diagnostic

Yes

The device is explicitly stated as "single-use in vitro diagnostic devices" in the "Device Description" section.

SaMD (Software as a Medical Device)

No

The device is described as a physical immunochromatographic assay in the format of Dip Cards or Cups, which are hardware components used for in vitro diagnostic testing.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Device Description: The document explicitly states, "The products are single-use in vitro diagnostic devices..."
Intended Use: The intended use describes the device as a "competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of [various drugs] in human urine". This is a classic description of an in vitro diagnostic test that analyzes a biological sample (urine) outside of the body to detect specific substances.
Methodology: The description of the device as an "immunochromatographic assay" that uses a "lateral flow system" is consistent with common IVD technologies.
Performance Studies: The document details performance studies involving the analysis of clinical samples (urine) and comparison to a reference method (LC/MS), which are standard practices for evaluating the performance of IVD devices.
Over-the-Counter Use: While intended for over-the-counter use, this does not preclude it from being an IVD. Many IVDs are designed for home use.

The information provided clearly indicates that this device is intended to be used outside of the body to diagnose or detect substances in a biological sample, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	300 ng/mL

Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	300 ng/mL

Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The tests are intended for over-the-counter use.

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

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

Device Description

The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

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

Not Found

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

Analytical Performance

Precision: Samples prepared at -100%, -75%, -50%, -25%, Cut-off, +25%, +50%, +75%, +100% of cut-off. Each drug concentration confirmed by LC/MS. Samples blindly labeled. Two runs per day for 25 days per device in randomized order.
- For 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine:
  - Dip Card: Lot 1 (50-/0+, 50-/0+, 50-/0+, 50-/0+, 24-/26+, 50+/0-, 50+/0-, 50+/0-, 50+/0-), Lot 2 (50-/0+, 50-/0+, 50-/0+, 50-/0+, 25-/25+, 50+/0-, 50+/0-, 50+/0-, 50+/0-), Lot 3 (50-/0+, 50-/0+, 50-/0+, 50-/0+, 26-/24+, 50+/0-, 50+/0-, 50+/0-, 50+/0-).
  - Cup: Lot 1 (50-/0+, 50-/0+, 50-/0+, 50-/0+, 27-/23+, 50+/0-, 50+/0-, 50+/0-, 50+/0-), Lot 2 (50-/0+, 50-/0+, 50-/0+, 50-/0+, 24-/26+, 50+/0-, 50+/0-, 50+/0-, 50+/0-), Lot 3 (50-/0+, 50-/0+, 50-/0+, 50-/0+, 26-/24+, 50+/0-, 50+/0-, 50+/0-, 50+/0-).
- Cut-off value of 300 ng/mL for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine is verified.
- References to K182654 for Methylenedioxy-Methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene; K181968 for Oxazepam, Methamphetamine, Morphine, Secobarbital and Methadone; K153646 for Amphetamine, Cocaine, and Cannabinoids precision data.
Linearity: Not applicable.
Stability: Stable at 4-30 ℃ for 24 months based on accelerated stability study at 50 °C and real-time stability studies at 4°C and 30 °C.
Interference: Potential interfering substances (e.g., Acetominophen, Albumin, Ethanol, etc.) added to drug-free and spiked urine samples at 25% below and 25% above Cut-Off levels. Tested using three batches of each device. No interference observed for listed compounds at 100 ug/mL (Albumin at 100 mg/dL, Ethanol at 1% vol). No differences between Cup and Dip Card formats.
Specificity: Drug metabolites and structure-related compounds tested using three batches of each device. Lowest concentration causing positive result listed for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (Methadone: 300000 ng/ml, 0.1% cross-reactivity; EMDP: 300000 ng/ml, 0.1% cross-reactivity; Doxylamine, Disopyramide, LAAM, Alpha Methadol: >100,000 ng/ml, 50 years.
Urine samples prepared at concentrations: negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug-free pooled urine specimens. Concentrations confirmed by LC/MS. Samples aliquoted and blind-labeled.
Each participant received package insert, 1 blind labeled sample, and a device. Each device was tested.
Results for Amphetamine (AMP):
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (253 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (496 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (753 ng/mL, 20 samples): 2 Positive, 18 Negative (90% correct)
- +25% Cutoff (1249 ng/mL, 20 samples): 17 Positive, 3 Negative (85% correct)
- +50% Cutoff (1498 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (1758 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for Cocaine (COC):
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (76 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (147 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (226 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct)
- +25% Cutoff (372 ng/mL, 20 samples): 18 Positive, 2 Negative (90% correct)
- +50% Cutoff (449 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (524 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for THC:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (12 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (24 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (36 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct)
- +25% Cutoff (63 ng/mL, 20 samples): 18 Positive, 2 Negative (90% correct)
- +50% Cutoff (75 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (88 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for BAR:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (76 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (147 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (225 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct)
- +25% Cutoff (374 ng/mL, 20 samples): 18 Positive, 2 Negative (90% correct)
- +50% Cutoff (449 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (524 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for BZO:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (76 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (147 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (227 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct)
- +25% Cutoff (374 ng/mL, 20 samples): 19 Positive, 1 Negative (95% correct)
- +50% Cutoff (450 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (526 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for MET:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (248 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (497 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (749 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct)
- +25% Cutoff (1251 ng/mL, 20 samples): 18 Positive, 2 Negative (90% correct)
- +50% Cutoff (1499 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (1754 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for MTD:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (76 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (147 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (223 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct)
- +25% Cutoff (374 ng/mL, 20 samples): 17 Positive, 3 Negative (85% correct)
- +50% Cutoff (450 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (526 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for OPI:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (501 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (999 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (1501 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct)
- +25% Cutoff (2499 ng/mL, 20 samples): 19 Positive, 1 Negative (95% correct)
- +50% Cutoff (2999 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (3501 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for MDMA:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (126 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (248 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (375 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct)
- +25% Cutoff (624 ng/mL, 20 samples): 18 Positive, 2 Negative (90% correct)
- +50% Cutoff (748 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (877 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for OXY:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (25 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (48 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (74 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct)
- +25% Cutoff (126 ng/mL, 20 samples): 18 Positive, 2 Negative (90% correct)
- +50% Cutoff (150 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (176 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for BUP:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (3 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (5 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (8 ng/mL, 20 samples): 2 Positive, 18 Negative (90% correct)
- +25% Cutoff (13 ng/mL, 20 samples): 18 Positive, 2 Negative (90% correct)
- +50% Cutoff (15 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (18 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for PCP:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (6 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (12 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (19 ng/mL, 20 samples): 2 Positive, 18 Negative (90% correct)
- +25% Cutoff (32 ng/mL, 20 samples): 18 Positive, 2 Negative (90% correct)
- +50% Cutoff (37 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (43 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for TCA:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (250 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (497 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (750 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct)
- +25% Cutoff (1249 ng/mL, 20 samples): 18 Positive, 2 Negative (90% correct)
- +50% Cutoff (1500 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (1749 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for PPX:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (76 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (148 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (223 ng/mL, 20 samples): 3 Positive, 17 Negative (85% correct)
- +25% Cutoff (374 ng/mL, 20 samples): 18 Positive, 2 Negative (90% correct)
- +50% Cutoff (448 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (525 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Results for EDDP:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -75% Cutoff (76 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct)
- -50% Cutoff (152 ng/mL, 170 samples): 0 Positive, 170 Negative (100% correct)
- -25% Cutoff (226 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct)
- +25% Cutoff (375 ng/mL, 20 samples): 18 Positive, 2 Negative (90% correct)
- +50% Cutoff (452 ng/mL, 40 samples): 40 Positive, 0 Negative (100% correct)
- +75% Cutoff (526 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct)
Lay-users indicated that device instructions can be easily followed.
Flesch-Kincaid reading analysis: Grade Level 7.

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

Not directly stated as sensitivity, specificity, PPV, NPV. Performance is shown by number of positive/negative results at various concentrations relative to the cutoff. Discordant results are explicitly mentioned.

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.

K182654

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.

K181968, K153646

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

§ 862.3100 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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

May 27, 2020

Safecare Biotech (Hangzhou) Co., Ltd. % Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877

Re: K201120

Trade/Device Name: SAFECARE® Multi-Drug Urine Test Dip Card SAFECARE® Multi-Drug Urine Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: NFT, NFW, NFY, NGG, NGI, NFV, NGL, PTH, NGM, PTG, QAW, QBF Dated: April 23, 2020 Received: April 27, 2020

Dear Joe Shia:

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. 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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K201120

Device Name

SAFECARE® Multi-Drug Urine Test Dip Card SAFECARE® Multi-Drug Urine Test Cup

Indications for Use (Describe)

SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	300 ng/mL

Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
FORM FDA 3881 (7/17)	Page 1 of 2

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Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	300 ng/mL

Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The tests are intended for over-the-counter use.

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

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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4

510(k) SUMMARY

510(k) Number: K201120

May 27, 2020 1. Date: Safecare Biotech (Hangzhou) Co. Ltd. 2. Submitter: 18 Haishu Road, Yuhang District Hangzhou, China 3. Contact person: Joe Shia LSI International Inc. 504E Diamond Ave., Suite I
Email: shiajl@yahoo.com SAFECARE® Multi-Drug Urine Test Dip Card 4. Device Name: SAFECARE® Multi-Drug Urine Test Cup

Gaithersburg, MD 20877 Telephone: 240-505-7880

Classification:

Class 2

Product Code	Classification	Regulation Section	Panel
NFT
Amphetamine	II	21 CFR § 862.3100, Amphetamine Test System	Toxicology (91)
NFW
Cannabinoids	II	21 CFR § 862.3870, Cannabinoids Test System	Toxicology (91)
NFY
Cocaine	II	21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System	Toxicology (91)
NGG
Methamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology (91)
NGI
Morphine	II	21 CFR § 862.3640, Morphine Test System	Toxicology (91)
NFV
Oxazepam	II	21 CFR § 862.3170, Benzodiazepine Test System	Toxicology (91)
NGL
Oxycodone	II	21 CFR § 862.3650, Opiate Test System	Toxicology (91)
PTH
Secobarbital	II	21 CFR § 862.3150, Barbiturate Test System	Toxicology (91)
NGL
Buprenorphine	II	21 CFR § 862.3650, Opiate Test System	Toxicology (91)
NGG
Methylenedioxy-methamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology (91)
NGM
Phencyclidine	unclassified	Enzyme Immunoassay Phencyclidine	Toxicology (91)
PTG
Methadone	II	21 CFR § 862.3620, Methadone Test System	Toxicology (91)
QAW
Nortriptyline	II	21 CFR, 862.3910 Tricyclic Antidepressant Drugs Test System	Toxicology (91)
QBF
Propoxyphene	II	21 CFR, 862.3700 Propoxyphene Test System	Toxicology (91)

5

Product Code	Classification	Regulation Section	Panel
PTG
2-ethylidene-1, 5-dimethyl-
3, 3-diphenylpyrrolidine	II	21 CFR § 862.3620, Methadone Test System	Toxicology
(91)

1. Predicate Device
  The SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup (K182654)
1. Intended Use
  SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	300 ng/mL

Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d

6

Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	300 ng/mL

Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine. Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

7. Device Description

The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

8. Substantial Equivalence Information

A summary comparison of features of the SAFECARE® Dip Card Tests and SAFECARE® Cup Tests and the predicate devices is provided in following tables.

7

Table 1: Features Comparison of SAFECARE® Dip Card Tests and the Predicate Device

Item	Device	Predicate - K182654
Indication(s)
for Use	For the qualitative determination of drugs of
abuse in human urine.	Same (but the number of
drugs detected is
different)
	Similarities
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For over-the-counter	Same
Configurations	Dip Card	Same
	Differences
Calibrator and Cut-Off
Values	Amphetamine (AMP): 1,000 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine (COC): 300 ng/ml
11-Nor-△9-Tetrahydrocannabinol-9-COOH
(THC):50 ng/ml
Methamphetamine (MET): 1,000 ng/ml
Morphine (OPI): 2000ng/ml
Secobarbital (BAR): 300 ng/ml
Methadone (MTD): 300 ng/ml
Methylenedioxymethamphetamine
(MDMA): 500 ng/ml
Oxycodone (OXY): 100 ng/ml
Buprenorphine (BUP): 10 ng/ml
Phencyclidine (PCP): 25 ng/ml
Nortriptyline (TCA): 1000 ng/ml
Propoxyphene (PPX): 300 ng/ml
2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine (EDDP): 300 ng/mL	Same as candidate device
with exclusion of 2-
ethylidene-1, 5-dimethyl-3,
3-diphenylpyrrolidine
(EDDP): 300 ng/mL

Table 2: Features Comparison of SAFECARE® Cup Tests and the Predicate Devices

Item	Device	Predicate - K182654
Indication(s)
for Use	For the qualitative determination of
drugs of abuse in human urine.	Same (but the number of
drugs detected is different)
Similarities

8

| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry. | Same |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | Cup | Cup |
| | Differences | |
| Calibrator and Cut-Off
Values | Amphetamine (AMP): 1,000 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine (COC): 300 ng/ml
11-Nor-△9-Tetrahydrocannabinol-9-COOH
(THC):50 ng/ml
Methamphetamine (MET): 1,000 ng/ml
Morphine (OPI): 2000ng/mL
Secobarbital (BAR): 300 ng/ml
Methadone (MTD): 300 ng/ml
Methylenedioxymethamphetamine
(MDMA): 500 ng/ml
Oxycodone (OXY): 100 ng/ml
Buprenorphine (BUP): 10 ng/ml
Phencyclidine (PCP): 25 ng/ml
Nortriptyline (TCA): 1000 ng/ml | Same as candidate device
with exclusion of 2-
ethylidene-1, 5-dimethyl-3,
3-diphenylpyrrolidine
(EDDP): 300 ng/mL |
| | Propoxyphene (PPX): 300 ng/ml
2-ethylidene-1, 5-dimethyl-3, 3-
diphenylpyrrolidine (EDDP): 300
ng/mL | |

9. Test Principle

The SAFECARE® Dip Card Tests, and SAFECARE® Cup Tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3diphenylpyrrolidine in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody

9

coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

1. Performance Characteristics
- 1. Analytical Performance
  - a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off. -50% cut off. -25% cut off. cut off. +25% cut off. +50% cut off. +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine. Please refer to K182654 for precision data for Methylenedioxy-Methamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene, and to K181968 for precision data for Oxazepam, Methamphetamine, Morphine, Secobarbital and Methadone, and to K153646 for precision data for Amphetamine, Cocaine, and Cannabinoids.

Dip Card
Results
Lot Number	-100% Cut-off	-75% Cut-off	-50% Cut-off	-25% Cut-off	Cut-off	Cut-off +25%	Cut-off +50%	Cut-off +75%	Cut-off +100%
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-

2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine

Cup
Results
Lot
Number	-100%
Cut-off	-75%
Cut-off	-50%
Cut-off	-25%
Cut-off	Cut-off	Cut-off
+25%	Cut-off
+50%	Cut-off
+75%	Cut-off
+100%
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-

The cut-off value of 300 ng/mL for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine is verified.

b. Linearity

Not applicable.

c. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 50 °C and real time stability studies at 4°C and 30 °C.
d. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration

10

of 100ug/mL. with the exception of albumin with no interference at a concentration of 100mg/dL and ethanol at 1% volume, are summarized in the following tables. There were no differences observed between the SAFECARE® Cup and Dip Card formats.

| Acetominophen (4-

Acetamidophenol)	Ecgonine methyl ester	D,L-Octopamine
Acetophenetidin	Erythromycin	Oxalic acid
N-Acetylprocainamide	ẞ-Estradiol	Oxolinic acid
Acetylsalicylic acid	Ethanol (1% vol)	Oxymetazoline
Albumin (100mg/dL)	Fenoprofen	Papaverine
Aminopyrine	Furosemide	Penicillin-G
Amoxicillin	Gentisic acid	Perphenazine
Ampicillin	Hemoglobin	Phenelzine
Apomorphine	Hydralazine	Prednisone
Ascorbic acid	Hydrochlorothiazide	DL-Propranolol
Aspartame	Hydrocortisone	D-Pseudoephedrine
Atropine	O-Hydroxyhippuric acid	Quinine
Benzilic acid	3-Hydroxytyramine	Ranitidine
Benzoic acid	Ibuprofen	Salicylic acid
Bilirubin	D,L-Isoproterenol	Serotonin (5- Hydroxytyramine)
Chloralhydrate	Isoxsuprine	Sulfamethazine
Chloramphenicol	Ketamine	Sulindac
Chlorothiazide	Ketoprofen	Tetrahydrocortisone, 3-acetate
Chlorpromazine	Labetalol	Tetrahydrocortisone 3-(β-
Dglucuronide)
Cholesterol	Loperamide	Tetrahydrozoline
Clonidine	Meperidine	Thiamine
Cortisone	Meprobamate	Thioridazine
(-) Cotinine	Methoxyphenamine	Triamterene
Creatinine	Nalidixic acid	DL-Tyrosine
Deoxycorticosterone	Naloxone	Trifluoperazine
Dextromethorphan	Naltrexone	Trimethoprim
Diclofenac	Naproxen	D,L-Tryptophan
Diflunisal	Niacinamide	Tyramine
Digoxin	Nifedipine	Uric acid
Diphenhydramine	Norethindrone	Verapamil
Disopyramide	Noscapine	Zomepirac

e. Specificity

To test specificity, drug metabolites and other structure related compounds that are likely to cross-react in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine. The rest of the data were in K182654 for for Methylenedioxy-Methamphetamine, Oxycodone, reported Buprenorphine, Phencyclidine, Nortriptyline and Propoxyphene, and K181968 for Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone. There were no differences observed between the SAFECARE® Cup and Dip Card formats.

| Compounds | Result
Positive at(ng/ml) | % Cross-Reactivity |
|-----------|------------------------------|--------------------|
| Methadone | 300000 | 0.1% |

11

EMDP	300000	0.1%
Doxylamine	>100,000	100,000

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS (ng/mL) | Lay person Results | No. of
Positive | | No. of
Negative | The percentage
of correct results
(%) |
|--------------|----------------------|-------------------------------------------|--------------------|--------------------|-----|--------------------|---------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 | | |
| -75% Cutoff | 20 | 253 | 0 | 20 | 100 | | |
| -50% Cutoff | 170 | 496 | 0 | 170 | 100 | | |
| -25% Cutoff | 20 | 753 | 2 | 18 | 90 | | |
| +25% Cutoff | 20 | 1249 | 17 | 3 | 85 | | |
| +50% Cutoff | 40 | 1498 | 40 | 0 | 100 | | |
| +75% Cutoff | 20 | 1758 | 20 | 0 | 100 | | |

13

COC:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct
results (%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 147 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 226 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 372 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 449 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 524 | 20 | 0 | 100 |

THC:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------|
| | | | No. of
Positive | No. of
Negative | of correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 12 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 24 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 36 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 63 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 75 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 88 | 20 | 0 | 100 |

BAR:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 147 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 374 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 449 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 524 | 20 | 0 | 100 |

14

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 147 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 227 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 374 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 450 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 526 | 20 | 0 | 100 |

BZO:

MET:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------|
| | | | No. of
Positive | No. of
Negative | of correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 248 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 497 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 749 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1251 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 1499 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1754 | 20 | 0 | 100 |

MTD:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------|
| | | | No. of
Positive | No. of
Negative | of correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 147 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 223 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 374 | 17 | 3 | 85 |
| +50% Cutoff | 40 | 450 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 526 | 20 | 0 | 100 |

15

% of Cutoff	Number of samples	Drug Concentration by LC/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	501	0	20	100
-50% Cutoff	170	999	0	170	100
-25% Cutoff	20	1501	1	19	95
+25% Cutoff	20	2499	19	1	95
+50% Cutoff	40	2999	40	0	100
+75% Cutoff	20	3501	20	0	100

MDMA:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 126 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 248 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 375 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 624 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 748 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 877 | 20 | 0 | 100 |

OXY:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 48 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 74 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 126 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 150 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 176 | 20 | 0 | 100 |

OPI:

16

BUP:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 3 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 5 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 8 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 13 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 15 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 18 | 20 | 0 | 100 |

PCP:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 6 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 12 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 19 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 32 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 37 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 43 | 20 | 0 | 100 |

TCA:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 497 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1249 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 1500 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1749 | 20 | 0 | 100 |

17

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage
of correct results
(%) |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 148 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 223 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 374 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 448 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |

PPX:

EDDP:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS(ng/mL) | Lay person Results | | The percentage |
|--------------|----------------------|------------------------------------------|--------------------|--------------------|---------------------------|
| | | | No. of
Positive | No. of
Negative | of correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 170 | 152 | 0 | 170 | 100 |
| -25% Cutoff | 20 | 226 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 375 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 526 | 20 | 0 | 100 |

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

1. Clinical Studies
  Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are substantially equivalent to the predicate.