Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a rapid chromatographic immunoassay, which is a traditional chemical-based test, and the summary does not mention any AI or ML components.

Therapeutic

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

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "intended for qualitative detection of drugs of abuse for health care professionals, in vitro diagnostic use and prescription use ONLY." This phrasing directly indicates its use as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "lateral flow, colloidal gold based chromatographic immunoassay," which is a physical test strip, not software.

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 Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card are intended for... in vitro diagnostic use and prescription use ONLY."
Nature of the Test: The device performs a rapid chromatographic immunoassay on human urine to detect the presence of specific drugs. This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample outside of the body to provide information about a person's health status (in this case, the presence of drugs of abuse).
Intended User and Setting: The device is intended for "health care professionals" and "prescription use ONLY," and is not for "point-of-care settings or over the counter use." This aligns with the typical use of IVDs in a clinical or laboratory setting under the supervision of healthcare professionals.
Comparison to Predicate Device: The submission mentions a predicate device (K020771 ACON (INNOVACON) One Step Drug Screen Test Card), which is also a drug screen test and likely an IVD itself, further supporting the classification of this device as an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid chromatographic immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:

Analyte	Abbreviation	Calibrator	Cutoff
Concentration
Amphetamine	AMP	d-Amphetamine	1000 ng/ml
Cocaine	COC	Benzoylecgonine	300 ng/ml
Marijuana	THC	11-nor-$\Delta^9$-THC9-COOH	50 ng/ml
Methamphetamine	MET	d-Methamphetamine	1000 ng/ml
Opiates	OPI/MOR	Morphine	300 ng/ml
Phencyclidine	PCP	Phencyclidine	25 ng/ml

The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card are intended for qualitative detection of drugs of abuse for health care professionals, in vitro diagnostic use and prescription use ONLY. It is not intended for point-of-care settings or over the counter use.

This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods.

Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

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

DKZ, DIO, DJC, DNK, LCM, LDJ

Device Description

Chemtrue® Single / Multi-panel Drug Screen Cassette and Dip Card tests are one-step, lateral flow, colloidal gold based chromatographic immunoassays for the rapid, qualitative detection of Amphetamine, Methamphetamine, Marijuana (THC), Phencyclidine, Cocaine and Opiates (Morphine) 300 in human urine. It is intended for Professional /Prescription Use ONLY. This assay provides a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory result. Clinical and professional judgment must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

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

health care professionals, in vitro diagnostic use and prescription use ONLY. It is not intended for point-of-care settings or 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

Analytical Sensitivity Study Data:
The results supported the claimed cut-off levels for each drug analyte and showed equivalent performance between Dip card and cassette formats.

Analytical Precision Study Data:
The precision study was conducted by three Operators with three batches per product format in replicates of 10 devices/lot at each control level of Negative, -50%, -25%, cut-off, +25% and +50% cutoff. The study was conducted in non-consecutive ten days using GC/MS confirmed commercial urine controls. The controls are blind coded according to a random table and evenly distributed to three operators. Every device was tested and interpreted by the same operator. The total of ten days run data is grouped into three sets: 3-day, 3-day and 4-day.

Analytical Accuracy Study Data:
The accuracy of the Chemtrue Drug Screen Test device was evaluated with the confirmed GC/MS values in the blind-labeled clinical specimen correlation study (a total of 673 clinical specimens).

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

Analytical Sensitivity Study Data:
Conclusion: The results support the claimed cut-off levels for each drug analyst. It also demonstrates that the performance of both Dip card and cassette product formats is consistent and equivalent.

Analytical Precision Study Data:
Conclusion: The results of the reproducibility study demonstrate that the Chemtrue® Drug Screen tests are able to produce consistent results from lot-to-lot, Operator-to-Operator and dayto-day runs, during the repeated assays and measurements. It also demonstrates an equivalent assay performance between Dip Card and Cassette formats.

Analytical Accuracy Study:
Study type: Method comparison (Accuracy) study
Sample size: 673 clinical specimens (tested against GC/MS values)
Key results:

Chemtrue® Single/Multi-panel Drug Screen Test is substantially equivalent to the performance characteristics of GC/MS methodology.
Correlation studies, using clinical specimens, produced a > 98% total correlation when compared to the GC/MS methodology.
The accuracy study data of Chemtrue® devices demonstrates the substantial equivalency to the data in the package insert of the predicate kit – ACON (INNOVACON) One Step Single and Multi Drug Screen test card.

Test	Positive Agreement	Negative Agreement	Overall Agreement
AMP	57/57 = 100%	56/57 = 98.2%	113/114 = 99.1%
COC	61/61= 100%	54/54= 100%	115/115= 100%
OPI(MOR)300	55/56= 98.2%	62/63 = 98.4%	117/119 = 98.3%
MET	54/56 = 96.4%	50/50 = 100%	104/106 = 98.1%
PCP	52/52= 100%	62/62= 100%	114/114 = 100%
THC	56/56 = 100%	50/50= 100%	106/106= 100%

Analytical Specificity Study:
The data is summarized in Section "Performance Characteristics, Specificity" and the raw data is enclosed in ATTACHMENT E of this submission. (No results provided in the summary)

Stability study:
Three lots of each product format: Dip Card and Cassette were included in the stability study.
Key results: Accelerated stability at 60°C and 40°C data supported two years shelf-life of the products. Accelerated 40°C and real-time stability studies are still on-going.

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

Positive Agreement:
AMP: 100% (57/57)
COC: 100% (61/61)
OPI(MOR)300: 98.2% (55/56)
MET: 96.4% (54/56)
PCP: 100% (52/52)
THC: 100% (56/56)

Negative Agreement:
AMP: 98.2% (56/57)
COC: 100% (54/54)
OPI(MOR)300: 98.4% (62/63)
MET: 100% (50/50)
PCP: 100% (62/62)
THC: 100% (50/50)

Overall Agreement:
AMP: 99.1% (113/114)
COC: 100% (115/115)
OPI(MOR)300: 98.3% (117/119)
MET: 98.1% (104/106)
PCP: 100% (114/114)
THC: 100% (106/106)

Analytical Accuracy: >96%

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.

K020771

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

§ 862.3100 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

0

510(k) Summary

AS REQUIRED BY 21 CFR 807.92(c)

JAN 2 0 2011

The Assigned 510(k) number is _ _ 102203

Date of Summary: August 3rd, 2010

Common Name: Drugs of Abuse Screening Tests

Classification Name: Immunoassay for the detection of drugs of abuse

Trade/Proprietary Name:

Chemtron Biotech, Inc.'s Chemtrue® Single / Multi-panel Drug Screen Dip Card / Cassette Tests, contain 1 to 6 of the following DOA test(s) in each device:

1. Amphetamine test strip
1. Cocaine test strip
1. Marijuana (THC) test strip
1. Methamphetamine test strip

с

1. Opiates (Morphine) cut-off: 300ng/ml test strip
1. Phencyclidine test strip

Owner:

Ellen Liu President, Chemtron Biotech, Inc. 8370 Juniper Creek Lane, #1-2 San Diego, CA 92126 TEL: (858) 530-2868 FAX: (858) 530-2878

Contact Person:

Jane Zhang, Director of QA/RA Official FDA Correspondent

8370 Juniper Creek Lane, #1-2 San Diego, CA 92126 Office: (858) 530-2868 Mobile: (858) 997-7472

1

FAX: (858) 530-2878

Substantial Equivalency:

The Chemtrue® Single/Multi Drug Screen Test is substantially equivalent to other tests currently on the market.

| Test Analyte | Predicate Device Name | Predicate Device
510(k) # |
|-----------------------|-------------------------------------------------|------------------------------|
| Amphetamine | ACON (INNOVACON) One Step Drug Screen Test Card | K020771 |
| Cocaine | ACON (INNOVACON) One Step Drug Screen Test Card | K020771 |
| Methamphetamine | ACON (INNOVACON) One Step Drug Screen Test Card | K020771 |
| THC | ACON (INNOVACON) One Step Drug Screen Test Card | K020771 |
| Opiates (Morphine)300 | ACON (INNOVACON) One Step Drug Screen Test Card | K020771 |
| PCP | ACON (INNOVACON) One Step Drug Screen Test Card | K020771 |

The predicate kit package insert is enclosed in ATTACHMENT A of this submission.

Proposed Labeling or Promotional Material for the Device:

Description of the device can be found in the attached proposed labeling, including an explanation of how the device functions, technical principle and concepts that form the basis for the device, as well as the physical and performance characteristics of the device design, materials used and physical properties. In accordance with FDA labeling requirements 21 CFR 809.10, enclosed are the draft copies of product labeling including copies of the technical product inserts. See ATTACHMENT B, C and D.

Intended Use

The Chemtrue® test device is intended for qualitative detection of drugs of abuse, for professional use, in vitro diagnostic use and for prescription use ONLY.

This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods.

Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

Technological Characteristics and Science Principles

The Drugs of Abuse (DOA) Screen Panels are one-step lateral flow immunoassays in which chemically labeled drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may

2

be present in urine. The test device consists of up to six test strips placed into separate panels of a plastic holder. On each test strip, a drug-protein conjugate is striped on the test band of the membrane - known as the test region (T) and the drug antibody-colloidal gold conjugate pads are placed at one end of the membrane (opposite in morphine). In the absence of drugs in the urine, the solution of the colored antibody-colloidal gold conjugates move along with the sample solution upward chromatographically by capillary action across the immobilized drug-protein conjugate zones on the test band region. The colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible precipitant in the test band occurs when the test urine is negative for the drug. If any drug is present in the urine, the drug/metabolite antigen competes with drug-protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. When a sufficient amount of drug is present in the urine, the drug will saturate the limited antibody binding sites and the colored antibody -colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result.

A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip at the control region (C) to indicate that the test has performed properly. This control line is manufactured as a built-in internal control of the test device and should always appear regardless of the presence of drug or metabolite. If the control line does not appear the test cassette should be discarded. The presence of this colored band in the control region also serves 1) as verification that adequate specimen volume is added (flooding, if too much urine is added, or no flow, due to insufficient urine volume), 2) the test device IS properly functioning, and 3) as reagent control.

Summary of Device Similarities and Differences

Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-panel Drug Screen Cassette and Dip Card tests are similar to other FDA-cleared devices for the qualitative detection of drugs of abuse tests: Amphetamine, Cocaine, Marijuana, Opiates, Methamphetamine and Phencyclidine test from other manufacturers such as ACON (Current INNOVACON), Branan Medical, etc. All of these products are based on the same technological characteristics, science principle and similar procedures. The similarities and differences between these tests are summarized as follows:

SIMILARITIES
Item	Chemtrue® Device	Predicate Kit
Intended Use/Indications for use	Qualitative detection of drugs-of- abuse in urine for Professional, Prescription, In Vitro	Same

3

		Diagnostic Use Only
Specimen		Urine	Same
Technological Characteristics and
Principle		One-Step lateral flow competitive
Immunoassay	Same
	Positive result	1 colored line	Same
Device Design/	Negative result	2 colored lines	Same
Performance	Detection
reagent	Colloidal gold	Same
	Accuracy
Assessment	Confirm with GC/MS reference method	Same
		Amphetamine 1000 ng/ml	Same
		Methamphetamine 1000 ng/ml	Same
	Cut-off	Cocaine 300 ng/ml	Same
		Marijuana (THC) 50 ng/ml	Same
		Phencyclidine 25 ng/ml	Same
		Opiates(Morphine) 300 ng/ml	Same
Safety and Precaution		All urine specimens should be considered
potentially hazardous and handled in the same
manner as infectious agent.	Same
Read time		5 minutes	Same
Storage		2 - 30 °C (36 - 86°F)	Same

DIFFERENCES
Item	Chemtrue® Device	Predicate Kit
Pre-treatment for urine
specimen	Does not require pre-treatment
for urine specimen. It is better
than the Predicate kit.	Urine specimen needs to be centrifuged,
filtered, or allowed to settle to obtain
clear specimen for testing.
Time Frame of Result
Stabilization	Do not read after 8 minutes.	Results remain stable for up to 4 hours
after test initiation.

DISCUSSION AND CONCLUSION:

Based on the technological characteristics/principle, features of the device designs, test specimen matrix, test method and performance characterizations, as the set forth above, it can be concluded

4

that Chemtrue® Single/ Multi-panel Drug Screen tests are substantially equivalent to the predicate kit ACON's (INNOVACON) One Step Single and Multi Drug Screen test card product presently distributed commercially.

One of the advantages of the Chemtrue® Drug Screen Tests is no urine specimen pre-treatment, which is better than the Predicate kit, because it is much simple and convenience for the intended user(s).

With regarding to the result read time frame difference, since the device labeling clearly indicates the required "Read Time", it does not impact the result interpretation by the intended user(s). The device safety and effectiveness won't be affected either. For detailed discussion, refer to the section "Substantial Equivalence Discussion" of this submission.

Performance Data:

Chemtron Biotech, Inc. has reviewed the requirements of Section 514 of the Act, which states that to date no performance standards has been established for drug screen test systems by the FDA.

However, the studies listed in the notification are conducted according to "The Draft Guidance for Industry and FDA Staff" - " Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests, issued on: December 2, 2003", including the design of draft labeling and package inserts.

Chemtrue® Single / Multi-panel Drug Screen Cassette and Dip Card tests are one-step, lateral flow, colloidal gold based chromatographic immunoassays for the rapid, qualitative detection of Amphetamine, Methamphetamine, Marijuana (THC), Phencyclidine, Cocaine and Opiates (Morphine) 300 in human urine. It is intended for Professional, Prescription Use ONLY.

This assay provides a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory result. Clinical and professional judgment must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The product performance characteristics of Chemtrue® Single/Multi-panel Drug Screen cassette and Dip Card were evaluated with the confirmed GC/MS values in the blind-labeled clinical specimen correlation study. The results of these studies demonstrate Chemtrue® Single/ Multi-panel Drug Screen Test to be substantially equivalent to the performance characteristics of GC/MS methodology. Correlation studies, using clinical specimens, produced a > 98% total correlation when compared to the GC/MS methodology. Also the accuracy study data of Chemtrue® devices demonstrates the substantial equivalency to the data in the package insert of the predicate kit – ACON (INNOVACON) One Step Single and Multi Drug Screen test card.

5

Chemtrue® Single /Multi-Panel Drug Screening Tests vs GC/MS Value Analysis

Samples with drug concentration above the cut-off level were considered presumptive positive and concentration below the cut-off were considered negative.

Test	Positive Agreement	Negative Agreement	Overall Agreement
AMP	57/57 = 100%	56/57 = 98.2%	113/114 = 99.1%
COC	61/61= 100%	54/54= 100%	115/115= 100%
OPI(MOR)300	55/56= 98.2%	62/63 = 98.4%	117/119 = 98.3%
MET	54/56 = 96.4%	50/50 = 100%	104/106 = 98.1%
PCP	52/52= 100%	62/62= 100%	114/114 = 100%
THC	56/56 = 100%	50/50= 100%	106/106= 100%

Table 1. The data was summarized from method comparison (Accuracy) study against the GC/MS values of the clinical specimens

Conclusion:

Compared to the GC/MS values of clinical urine specimens (Total of 673 specimens), the results of the Accuracy (Method comparison) study demonstrate the substantial equivalency between the Chemtrue® Single/ Multi-Panel Drug Screen tests and the GC/MS reference method. It is also equivalent to the predicate kit, when compared to the data provided in the package insert of the predicate kit [ACON (INNOVACON) One Step Drug Screen test card]. The results demonstrated that Chemtrue® Single/ Multi-panel Drug Screen cassette and Dip card is safe and effective in detecting Amphetamine, Cocaine, Methamphetamine, Marijuana, Opiates (Morphine) 300 and Phencyclidine in human urine.

Other non-clinical performance data, such as analytical sensitivity (Cutoff characteristics), precision (Reproducibility), specificity (Cross-reactivity and interference) and stability studies are summarized in Section "Performance Characteristics", and the raw data is enclosed in ATTACHMENT E and ATTACHMENT G of this submission.

510(k) Summary was prepared By: Jane Zhang on August 3rd, 2010

PREMARKET NOTIFICATION

TRUTHFUL AND ACCURATE STATEMENT

(As required by 21 CFR 807.87(j))

6

I certify that in my capacity as QA/RA Director of Chemtron Biotech, Inc., I believe to the best of my knowledge that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

(Signature), (Date)

Jane Zhang

Director of QA/RA, Chemtron Biotech, Inc.

FDA Official Correspondent

K

510(k) Number

Executive Summary

Description of the Device

Chemtrue® Single / Multi-panel Drug Screen Cassette and Dip Card tests are one-step, lateral flow, colloidal gold based chromatographic immunoassays for the rapid, qualitative detection of

7

Amphetamine, Methamphetamine, Marijuana (THC), Phencyclidine, Cocaine and Opiates (Morphine) 300 in human urine. It is intended for Professional /Prescription Use ONLY.

This assay provides a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory result. Clinical and professional judgment must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Concise Summary of Performance Testing:

| Control Level | No. of
Tested | No. of Negative | | | | | | | |
|--------------------|------------------|-----------------|-------------|-------------|----------------|-------------|-------------|----------------|-----------------------|
| | | AMP
n=30 | COC
n=30 | THC
n=30 | OPI300
n=30 | MET
n=30 | PCP
n=30 | No. of
Neg. | No. of
Preliminary |
| 0 | 180 | 30 | 30 | 30 | 30 | 30 | 30 | 180 | 0 |
| -50% of the cutoff | 180 | 30 | 30 | 30 | 30 | 30 | 30 | 180 | 0 |
| -25% of the cutoff | 180 | 30 | 30 | 30 | 30 | 29 | 29 | 178 | 2 |
| Cut-off | 180 | 18 | 16 | 17 | 16 | 15 | 14 | 112 | 68 |
| +25% of the cutoff | 180 | 1 | 4 | 3 | 1 | 2 | 1 | 12 | 168 |
| +50% of the cutoff | 180 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 180 |

1. Analytical Sensitivity Study Data
  Conclusion: The results support the claimed cut-off levels for each drug analyst. It also demonstrates that the performance of both Dip card and cassette product formats is consistent and equivalent.

2. Analytical Precision Study Data:

The precision study was conducted by three Operators with three batches per product format in replicates of 10 devices/lot at each control level of Negative, -50%, -25%, cut-off, +25% and +50% cutoff. The study was conducted in non-consecutive ten days using GC/MS confirmed commercial urine controls. The controls are blind coded according to a random table and evenly distributed to three operators. Every device was tested and interpreted by the same operator. The total of ten days run data is grouped into three sets: 3-day, 3-day and 4-day. A concise summary is in Table below:

Control Level	n	3-Day		3-Day		4-Day		TOAL
		+	-	+	-	+	-	+	-
Negative	30	0	8	0	13	0	9	0	30
-50% of cutoff	30	0	12	0	5	0	13	0	30
-25% of cutoff	30	1	11	0	10	0	8	1	29

AMP Test: Cutoff: 1000 ng/ml (Three lots were tested by three Operators)

8

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Cocaine Test: Cutoff: 300 ng/ml (Three lots were tested by three Operators)

Control Level	n	3-Day		3-Day		4-Day		TOAL
		+	-	+	-	+	-	+	-
Negative	30	0	10	0	9	0	11	0	30
-50% of cutoff	30	0	11	0	8	0	11	0	30
-25% of cutoff	30	0	10	0	7	0	13	0	30
Cutoff	30	4	6	4	4	4	8	12	18
+25% of cutoff	30	3	0	13	1	10	3	26	4
+50% of cutoff	30	10	0	8	0	12	0	30	0

MAMP Test: Cutoff: 1000 ng/ml(Three lots were tested by three Operators)

Control Level	n	3-Day		3-Day		4-Day		TOAL
		+	-	+	-	+	-	+	-
Negative	30	0	8	0	11	0	11	0	30
-50% of cutoff	30	0	11	0	8	0	11	0	30
-25% of cutoff	30	0	10	1	9	0	10	1	29
Cutoff	30	6	6	3	4	4	7	13	17
+25% of cutoff	30	6	0	7	0	16	1	29	1
+50% of cutoff	30	7	0	11	0	12	0	30	0

OPI (MOR) Test: Cutoff: 300 ng/ml (Three lots were tested by three Operators)

Control Level	n	3-Day		3-Day		4-Day		TOAL
		+	-	+	-	+	-	+	-
Negative	30	0	11	0	7	0	12	0	30
-50% of cutoff	30	0	12	0	11	0	7	0	30
-25% of cutoff	30	0	4	0	8	1	17	1	29
Cutoff	30	5	6	3	2	7	7	15	15
+25% of cutoff	30	7	1	11	0	10	1	28	2
+50% of cutoff	30	8	0	12	0	10	0	30	0

PCP Test: Cutoff: 25 ng/ml (Three lots were tested by three Operators)

Control Level	n	3-Day		3-Day		4-Day		TOAL
		+	-	+	-	+	-	+	-
Negative	30	0	8	0	9	0	13	0	30
-50% of cutoff	30	0	13	0	7	0	10	0	30
-25% of cutoff	30	0	9	0	10	0	11	0	30

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+25% of cutoff
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Control Level	n	3-Day		3-Day		4-Day		TOAL
		+	-	+	-	+	-	+	-
Negative	30	0	3	0	10	0	17	0	30
-50% of cutoff	30	0	7	0	12	0	11	0	30
-25% of cutoff	30	0	9	0	6	0	15	0	30
Cutoff	30	3	7	4	2	5	9	12	18
+25% of cutoff	30	13	1	12	1	2	1	27	3
+50% of cutoff	30	11	0	7	0	12	0	30	0

THC Test: Cutoff: 50 ng/ml (Three lots were tested by three Operators)

The study raw data are enclosed in the ATTACHMENT E for reference.

Conclusion: The results of the reproducibility study demonstrate that the Chemtrue® Drug Screen tests are able to produce consistent results from lot-to-lot, Operator-to-Operator and dayto-day runs, during the repeated assays and measurements. It also demonstrates an equivalent assay performance between Dip Card and Cassette formats

1. Analytical Accuracy Study: The accuracy of the Chemtrue Drug Screen Test device was evaluated with the confirmed GC/MS values in the blind-labeled clinical specimen correlation study (a total of 673 clinical specimens). The results of these studies demonstrate Chemtrue® Single/ Multi-panel Drug Screen Test to be substantially equivalent to the performance characteristics of GC/MS methodology. Correlation studies, using clinical specimens, produced a > 98% total correlation when compared to the GC/MS methodology. Also the accuracy study data of Chemtrue® devices demonstrates the substantial equivalency to the data in the package insert of the predicate kit – ACON (INNOVACON) One Step Single and Multi Drug Screen test card. For details, refer to the "Method comparison (Accuracy) study, section Performance Characteristics" of this submission.
1. Analytical Specificity Study: The data is summarized in Section "Performance Characteristics, Specificity" and the raw data is enclosed in ATTACHMENT E of this submission.
1. Stability study: Three lots of each product format: Dip Card and Cassette were included in the stability study, and accelerated stability at 60°C and 40°C data supported two years shelf-life of the products. Accelerated 40°C and real-time stability studies are still on-going. The copy of the . raw data is enclosed in ATTACHMENT G.

Substantial Equivalency:

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Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-panel Drug Screen Cassette and Dip Card tests are similar to other FDA-cleared devices for the qualitative detection of drugs of abuse tests: Amphetamine, Cocaine, Marijuana, Opiates, Methamphetamine and Phencyclidine test from other manufacturers such as ACON (Current INNOVACON), Branan Medical, etc. All of these products are based on the same principle, same technological characteristics and similar procedures.

| Product Attribute | Chemtrue® Drug Screen Tests | Predicate Kit | Substantially
Equivalent |
|---------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Amphetamine, Cocaine,
Methamphetamine, Opiates (MOR),
PCP and THC | Amphetamine, Cocaine,
Methamphetamine, Opiates
(MOR/MOP) and THC, as well as
six other drug analytes | Yes |
| Intended Use | Qualitative detection of drugs-of-
abuse in urine | Qualitative detection of drugs-of-
abuse in urine | Yes |
| Specimen Type | urine | urine | Yes |
| Assay Methodology | Lateral flow immunochromato-
graphic assay | Lateral flow immunochromato-
graphic assay | Yes |
| Assay Cut-off | Amphetamine 1000ng/mL
Cocaine 300ng/mL
Methamphetamine 1000ng/mL
OPI (MOR) 300 ng/mL
PCP 25 ng/mL
THC 50ng/mL | Amphetamine 1000ng/mL
Cocaine 300ng/mL
Methamphetamine 1000ng/mL
OPI (MOR) 300 ng/mL
PCP 25 ng/mL
THC 50ng/mL | Yes |
| Time to read | 5 minutes | 5 minutes | Yes |
| Indications of Use | Prescription | Prescription | Yes |
| Analytical Accuracy | >96% | >90% | Yes |

Device Comparison:

DIFFERENCES
Attribute	Chemtrue® Device	Predicate Kit
Pre-treatment for urine specimen	Does not require pre-treatment for urine specimen. It is better than the Predicate kit.	Urine specimen needs to be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing.
Time Frame of Result Stabilization	Do not read after 8 minutes.	Results remain stable for up to 4 hours after test initiation.

DISCUSSION AND CONCLUSION:

Based on the technological characteristics/principle, features of the device designs, test specimen matrix, test method and performance characterizations, as the set forth above, it can be concluded that Chemtrue® Single/ Multi-panel Drug Screen tests are substantially equivalent to the predicate

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kit ACON's (INNOVACON) One Step Single and Multi Drug Screen test card product presently distributed commercially.

The difference of the read time claims between Chemtrue® device and the predicate kit does not impact the result interpretation by the intended user(s), since the device labeling clearly indicates the required "Read Time". The device safety and effectiveness won't be affected either. For details, refer to the section "Substantial Equivalence Discussion" of this submission.

Proposed Labeling

Package Labeling - Copies of the final draft package labeling for the Chemtron Biotech, Inc.'s Chemtrue® Single/ Multi-panel Drug Screen Cassette and Dip Card tests are in Attachment B and C. It is our intention that final package labeling will be substantially similar to the draft labeling attached.
Package Insert – A copy of the final draft package insert is enclosed in ATTACHMENT D. The final package insert will be substantially similar to that enclosed.
Promotional Material - Promotional material and advertising materials, when prepared, will be consistent with the product package insert and this 510(k) pre-market notification submission.

Summarized By: Jane Zhang

Date: August 3rd, 2010

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

Chemtron Biotech, Inc. c/o Jane Zhang Official FDA Correspondent 8370 Juniper Creek Lane Suite 1-2 San Diego, CA 92126

JAN 20 201

Re: Re: K102203 Trade/Device Name: Chemirue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests
Requlation Number 21 CFD 860 2140 Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: II Product Code: DKZ, DIO, DJC, DNK, LCM, LDJ Dated: January 10, 2011 Received: January 10, 2011

Dear Ms. Zhang,

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 in microadcon in micrisate conninents, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, or 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 of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, RDA 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Page 2 –

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of 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/cdrh/industry/support/index.html.

Sincerely yours,

G.C.

Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K102203

Device Name: Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests

Indications for Use:

The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid chromatographic immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:

Analyte	Abbreviation	Calibrator	Cutoff
Concentration
Amphetamine	AMP	d-Amphetamine	1000 ng/ml
Cocaine	COC	Benzoylecgonine	300 ng/ml
Marijuana	THC	11-nor- $\Delta^9$ -THC9-COOH	50 ng/ml
Methamphetamine	MET	d-Methamphetamine	1000 ng/ml
Opiates	OPI/MOR	Morphine	300 ng/ml
Phencyclidine	PCP	Phencyclidine	25 ng/ml

The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card are intended for qualitative detection of drugs of abuse for health care professionals, in vitro diagnostic use and prescription use ONLY. It is not intended for point-of-care settings or over the counter use.

This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods.

Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Divisions Sign Off

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

510(k) K102203

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