Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a lateral flow immunoassay, which is a chemical test, not a software-based technology like AI/ML. There is no mention of AI, ML, or any computational analysis of the results.

Therapeutic

No
This device is a diagnostic device intended to detect the presence of drugs and drug metabolites in human urine. It is not intended for therapeutic treatment.

Diagnostic

Yes
The document explicitly states "The test is intended for in vitro diagnostics use." in the "Intended Use / Indications for Use" section.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "lateral flow immunochromatographic assay" and comes in "Test Cup" and "Test Dipcard" formats, which are physical hardware components used for in vitro diagnostics.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The test is intended for in vitro diagnostics use."
Nature of the Test: The device is designed to detect the presence of drugs and drug metabolites in human urine, which is a biological sample taken from the body. This is a core characteristic of in vitro diagnostics.
Purpose: The purpose is to provide a preliminary analytical test result for the presence of specific substances in a biological sample, which is the definition of an in vitro diagnostic test.
Intended User/Setting: While it's intended for prescription use in clinical laboratories and not point-of-care, this still falls under the umbrella of in vitro diagnostics performed in a clinical setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral Now chromatographic immunoassy designed to qualitatively detect the presence of drug metabolites in human urine at the following cut-off concentrations:

Test	Calibrator	Cut-off level
Barbiturates (BAR)	Secobarbital	300 ng/mL
Benzodiazepines (BZO)	Oxazepam	300 ng/mL
Methylenedioxymethamphetamine (MDMA)	3,4-Methylenedioxymethamphetamine	500 ng/mL
Methadone (MTD)	Methadone	300 ng/mL
Oxycodone (OXY)	Oxycodone	100 ng/mL
Phencyclidine (PCP)	Phencyclidine	25 ng/mL

The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug sereening test is intended for in viro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectromerry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

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

DIS, JXM, DJC, DJR, DJG, LCM

Device Description

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Barbiturates, Benzodiazepines, Methylenedioxymethamine, Methadone, Oxycodone, Phencyclidine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

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

prescription use in clinical laboratories only and not for point-of-care 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

80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Single drug Test Cup. Samples were divided by concentration into five categories:drug free, less than half the cutoff negative, near cutoff positive, and high positive.
80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Single drug Test Dipcard. Samples were divided by concentration into five categories: drug free,less than half the cutoff, near cutoff negative, near cutoff positive, and high positive.
80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Multi-drug Test Cup. Samples were divided by concentration into five categories:drug free, less than half the cutoff negative, near cutoff positive, and high positive.
80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Multi-drug Test Dipcard. Samples were divided by concentration into five categories: drug free, less than half the cutoff negative, near cutoff positive, and high positive.

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

Accuracy Study:

Study Type: Accuracy study comparing device results to GC/MS analysis.
Sample Size: 80 clinical urine specimens for each drug type for Single drug Test Cup, Single drug Test Dipcard, Multi-drug Test Cup, and Multi-drug Test Dipcard.
Key Results (Sample Tables):
- Single drug Test Cup:
  - BAR: 34 high positive, 6 near cutoff positive
  - BZO: 33 high positive, 7 near cutoff positive, 1 near cutoff negative
  - MDMA: 34 high positive, 5 near cutoff positive, 1 near cutoff negative, 3 less than half the cutoff, 5 near cutoff negative
  - MTD: 35 high positive, 5 near cutoff positive, 1 near cutoff negative, 2 less than half the cutoff, 5 near cutoff negative
  - OXY: 34 high positive, 6 near cutoff positive
  - PCP: 35 high positive, 5 near cutoff positive, 1 near cutoff negative
- Single drug Test Dipcard:
  - BAR: 34 high positive, 6 near cutoff positive
  - BZO: 33 high positive, 7 near cutoff positive, 1 near cutoff negative
  - MDMA: 34 high positive, 5 near cutoff positive, 1 near cutoff negative, 3 less than half the cutoff, 5 near cutoff negative
  - MTD: 35 high positive, 5 near cutoff positive, 1 near cutoff negative, 2 less than half the cutoff, 5 near cutoff negative
  - OXY: 34 high positive, 6 near cutoff positive
  - PCP: 35 high positive, 5 near cutoff positive, 1 near cutoff negative
- Multi-drug Test Cup:
  - BAR: 34 high positive, 6 near cutoff positive
  - BZO: 33 high positive, 7 near cutoff positive, 1 near cutoff negative
  - MDMA: 34 high positive, 5 near cutoff positive, 1 near cutoff negative, 3 less than half the cutoff, 5 near cutoff negative
  - MTD: 35 high positive, 5 near cutoff positive, 1 near cutoff negative, 2 less than half the cutoff, 5 near cutoff negative
  - OXY: 34 high positive, 6 near cutoff positive
  - PCP: 35 high positive, 5 near cutoff positive, 1 near cutoff negative
- Multi-drug Test Dipcard:
  - BAR: 34 high positive, 6 near cutoff positive
  - BZO: 33 high positive, 7 near cutoff positive, 1 near cutoff negative
  - MDMA: 34 high positive, 5 near cutoff positive, 1 near cutoff negative, 3 less than half the cutoff, 5 near cutoff negative
  - MTD: 35 high positive, 5 near cutoff positive, 1 near cutoff negative, 2 less than half the cutoff, 5 near cutoff negative
  - OXY: 34 high positive, 6 near cutoff positive
  - PCP: 35 high positive, 5 near cutoff positive, 1 near cutoff negative

Analysis of Discordant Results (across all tests and formats):

BZO: One Positive test result with GC/MS concentration of 188 ng/mL (Cutoff: 300 ng/mL)
MDMA: One Negative test result with GC/MS concentration of 715 ng/mL (Cutoff: 500 ng/mL)
MTD: One Positive test result with GC/MS concentration of 209 ng/mL (Cutoff: 300 ng/mL)
PCP: One Positive test result with GC/MS concentration of 23 ng/mL (Cutoff: 25 ng/mL)

Other Performance Characteristics:

Precision study
Sensitivity study
Specificity and cross reactivity study
Interference study
Stability study
Conclusion: The study results indicate that One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard perform satisfactorily when used according to the package inserts.

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

Not Found (Raw data for calculation is provided but not calculated metrics)

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.

UCP Home™ Drug Screening Test Cards K091588, UCP Home™ Drug Screening Test Cup

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

§ 862.3150 Barbiturate test system.

(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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

0

KI40215

JUN 1 6 2014

Co-Innovation Biotech Co.,Ltd.

Section 5 - 510(k) Summary

Date of Summary Preparation: 5/19/2014

1. Submitter's Identifications

Submitter: Co-Innovation Biotech Co.,Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

Correspondent's Identifications

Correspondent's Name: Co-Innovation Biotech Co.,Ltd. Address: No. 13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

3. Name of the Device

Recommended classification regulation:

21 CFR 862.3150 Barbiturate test system 21 CFR 862.3170 Benzodiazepine test system 21 CFR 862.3610 Methamphetamine test system 21 CFR 862.3620 Methadone test system 21 CFR 862.3650 Opiate test system Unclassified,Enzyme immunoassay,phencyclidine

Device class: Class II Panel: Toxicology (91) Product code: DIS,JXM,DJC,DJR,DJG,LCM Common Name:

Barbiturates (BAR) Test System

Benzodiazepines (BZO) Test System Methylenedioxymethamphetamine (MDMA) Test System Methadone (MTD) Test System Oxycodone (OXY) Test System Phencyclidine (PCP) Test System

Proprietary names:

One Step Single/Multi-drug Test Cup One Step Single/Multi-drug Test Dipcard

05-1

1

4. The Predicate Devices

UCP Home™ Drug Screening Test Cards K091588 UCP Home™ Drug Screening Test Cup

5. Device Description

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Barbiturates, Benzodiazepines, Methylenedioxymethamine, Methadone, Oxycodone, Phencyclidine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

6. Intended Use of Device

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

Test	Calibrator	Cut-off level
Barbiturates (BAR)	Secobarbital	300 ng/mL
Benzodiazepines (BZO)	Oxazepam	300 ng/mL
Methylenedioxymethampheta
mine (MDMA)	3,4-Methylenedioxymetha
mphetamine	500 ng/mL
Methadone (MTD)	Methadone	300 ng/mL
Oxycodone (OXY)	Oxycodone	100 ng/mL
Phencyclidine (PCP)	Phencyclidine	25 ng/mL

The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

7. Comparison to Predicate Devices:

A summary comparison of features of the One Step Single/Multi-drug Test Cup and One Step

2

Single/Multi-drug Test Dipcard and the predicate devices is provided in the following Table:

Item	Device	Predicate (K091588)
Indication for use	Qualitative detection of
drugs-of-abuse in urine (Barbiturates, Benzodiazepines,
Methylenedioxymethamphetamine,
Methadone,Oxycodone,Phencyclidine)	Same (but the number of
drugs detected different)
Intended Users	Prescription Use	Over the Counter (OTC) Use
and Prescription Use
Specimen	Urine	Same
Cutoff	Barbiturates:300 ng/mL
Benzodiazepines:300 ng/mL
Methylenedioxymethamphetamine:500
ng/mL
Methadone:300 ng/mL
Oxycodone:100 ng/mL
Phencyclidine:25 ng/mL	Same
Read time	5 minutes	Same
Storage	4~30 °C	2 ~ 30 °C
Results	Qualitative	Same
Methodology	Competitive binding, Lateral flow
immunochromatographic assay based
on the principle of antigen antibody
immunochemistry	Same
Configuration	Dipcard and Cup	Card and Cup

Remark:

1. The subject devices have all features of the predicate device except the number of drugs detected and storage temperature condition . These differences do not affect the performance characteristics of the subject devices.

8. Performance Data:

Accuracy

Single drug Test:

80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Single drug Test Cup. Samples were divided by concentration into five categories:drug free, less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:

| Drug
Test | Co-Innov
ation
Result | Drug free by
GC/MS analysis | Less than half
the cutoff
concentration
by GC/MS
analysis | Near Cutoff
Negative (Between
50% below the
cutoff and the cutoff
concentration) | Near Cutoff
Positive (Between
the cutoff and
50% above the
cutoff
concentration) | High Positive
(greater than
50% above the
cutoff
concentration) | Total |
|--------------|-----------------------------|--------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------|
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |

3

		33	0	7	0	0
BZO	+	0	0	1	7	33	80
	-	31	0	8	0	0
MDMA	+	0	0	0	5	34	80
	-	32	3	5	1	0
MTD	+	0	0	1	5	35	80
	-	32	2	5	0	0
OXY	+	0	0	0	6	34	80
	-	35	0	5	0	0
PCP	+	0	0	1	5	35	80
	-	35	0	4	0	0

Analysis of Discordant Results with One Step Single drug Test Cup

One Step Single drug Test Cup			GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	Drug Concentration (ng/mL)	Drug in Urine
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine

80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Single drug Test Dipcard. Samples were divided by concentration into five categories: drug free,less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. Results were as follows:

| Drug
Test | Co-Innovation
Result | Drug free by
GC/MS analysis | Less than half
the cutoff
concentration
by GC/MS
analysis | Near Cutoff
Negative (Between
50% below the
cutoff and the cutoff
concentration) | Near Cutoff
Positive (Between
the cutoff and
50% above the
cutoff
concentration) | High Positive
(greater than
50% above the
cutoff
concentration) | Total |
|--------------|-------------------------|--------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------|
| BAR | ÷ | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 0 | 7 | 0 | 0 | |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| | - | 31 | 0 | 8 | 0 | 0 | |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| | - | 32 | 3 | 5 | 1 | 0 | |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 32 | 2 | 5 | 0 | 0 | |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 35 | 0 | 5 | 0 | 0 | |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 35 | 0 | 4 | 0 | 0 | |

Analysis of Discordant Results with One Step Single drug Test Dipcard

	One Step Single drug Test Dipcard	GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	Drug
Concentration
(ng/mL)	Drug in Urine
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone

4

PCP	25	Positive	23	Phencyclidine
-----	----	----------	----	---------------

Multi-drug Test:

80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Multi-drug Test Cup. Samples were divided by concentration into five categories:drug free, less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:

| Drug
Test | Co-Innov
ation
Result | Drug free by
GC/MS analysis | Less than half
the cutoff
concentration
by GC/MS
analysis | Near Cutoff
Negative (Between
50% below the
cutoff and the cutoff
concentration) | Near Cutoff
Positive (Between
the cutoff and
50% above the
cutoff
concentration) | High Positive
(greater than
50% above the
cutoff
concentration) | Total |
|--------------|-----------------------------|--------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------|
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
| BAR | - | 33 | 0 | 7 | 0 | 0 | 80 |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| BZO | - | 31 | 0 | 8 | 0 | 0 | 80 |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| MDMA | - | 32 | 3 | 5 | 1 | 0 | 80 |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| MTD | - | 32 | 2 | 5 | 0 | 0 | 80 |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| OXY | - | 35 | 0 | 5 | 0 | 0 | 80 |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| PCP | - | 35 | 0 | 4 | 0 | 0 | 80 |

Analysis of Discordant Results with One Step Multi-drug Test Cup

| Drug Test | Cutoff(ng/mL) | Test Result | Drug
Concentration
(ng/mL) | Drug in Urine |
|-----------|---------------|-------------|----------------------------------|-----------------------------------|
| BZO | 300 | Positive | 188 | Oxazepam |
| MDMA | 500 | Negative | 715 | 3,4-Methylenedioxymethamphetamine |
| MTD | 300 | Positive | 209 | Methadone |
| PCP | 25 | Positive | 23 | Phencyclidine |

80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Multi-drug Test Dipcard. Samples were divided by concentration into five categories: drug free, less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:

| Drug
Test | Co-Innovation
Result | Drug free by
GC/MS analysis | Less than half
the cutoff
concentration
by GC/MS
analysis | Near Cutoff
Negative (Between
50% below the
cutoff and the cutoff
concentration) | Near Cutoff
Positive (Between
the cutoff and
50% above the
cutoff
concentration) | High Positive
(greater than
50% above the
cutoff
concentration) | Total |
|--------------|-------------------------|--------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------|
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
| BAR | - | 33 | 0 | 7 | 0 | 0 | |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| BZO | - | 31 | 0 | 8 | 0 | 0 | |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| MDMA | - | 32 | 3 | 5 | 1 | 0 | |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |

5

| | Acres of a | e
--------- | and and the contraction of the comments of the comments of the first of the first of the first of the first of the first of the first of the first of the first of the first o
| . | | |
|------------------------------------------------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| nuv
A B R B R B R B R B B B B B B B B B B B B B B | Submittee | | | | | 80 |
| | l | | | | | |
| DOD | | | | AND AND ANNUALIZA AND AN AN A A BREACH AND A LEA CRANIEL A LE A LEA BELLER A LE A LEA BELLER A LE A LEA BELLER A LE A LEA BELLER A LE A LEA BELLER AND | | THE ARTIS LAND A FRIEND AND A FRIEND OF A CHARLES OF A LEAST FOR A FOR A FOR A FOR A FOR A FOR A CONTRACT OF CLASS OF COLL CALL CONTRACT OF CLASS OF COLL CALL CONTAIN AND A C

80 |
| | 1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | A LE LE LE LE LE LE RESERVED LE LE LE LE LE LE LE SERVED LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE | | |

Analysis of Discordant Results with One Step Multi-drug Test Dipcard

One Step Multi-drug Test Dipcard			GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	Drug
Concentration
(ng/mL)	Drug in Urine
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine

Other Information About Performance Characteristics:

The performance characteristics of One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard were evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study. The study results indicate that One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard perform satisfactorily when used according to the package inserts.

10. Conclusion:

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are substantially equivalent to UCP Home™ Drug Screening Test Cards and UCP Home™ Drug Screening Test Cup.

--- End of this section ---

6

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

Public Health Service

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

June 16, 2014

CO-INNOVATION BIOTECH CO., LTD. HONG FENG, PRODUCT MANAGER NO. 13 YANYUAN ROAD. TIANHE DISTRICT GUANGZHOU, GUANGDONG 510507 CH

Re: K140215

Trade/Device Name: One Step Single/Multi-drug Test Cup; One Step Single/Multi-drug Test Dipcard Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: II Product Code: DIS, JXM, DJC, DJR, DJG, LCM Dated: January 28, 2014 Received: January 28, 2014

Dear Hong Feng:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

7

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also. please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

: ··· ・・・・

http://www.lda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

: : : :

Sincerely yours,

Courtney H. Lias -S

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

Enclosure

8

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140215

Device Name

One Step Single/Multi-drug Test Cup One Step Single/Multi-drug Test Dipcard

Indications for Use (Describe)

One Step SingleMulti-drug Test Cup and One Step SingleMulti-drug Test Dipcard are lateral Now chromatographic immunoassy designed to qualitatively detect the presence of drug metabolites in human urine at the following cut-off concentrations:

Test	Calibrator	Cut-off level
Barbiturates (BAR)	Secobarbital	300 ng/mL
Benzodiazepines (BZO)	Oxazepam	300 ng/mL
Methylenedioxymethamphetamine (MDMA)	3,4-Methylenedioxymethamphetamine	500 ng/mL
Methadone (MTD)	Methadone	300 ng/mL
Oxycodone (OXY)	Oxycodone	100 ng/mL
Phencyclidine (PCP)	Phencyclidine	25 ng/mL

The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug sereening test is intended for in viro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectromerry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

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)

. · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Denise Johnson-

FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

9

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."