(126 days)
Not Found
No
The device is a lateral flow immunoassay, which is a chemical and biological test method, not a digital or computational one. The description focuses on the biological components and the competition for antibody binding sites. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML.
No.
This device is an in vitro diagnostic (IVD) test intended for the qualitative detection of drugs of abuse in human urine, providing only a preliminary result. It is not used to treat, prevent, or diagnose a disease or condition in a patient.
Yes.
The "Intended Use / Indications for Use" section explicitly states "The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for in vitro diagnostic and prescription use ONLY." and it is also listed that "The Drugs of Abuse (DOA) Screen Panels are one-step lateral flow immunoassays". This confirms its diagnostic purpose.
No
The device description clearly describes a physical lateral flow immunoassay device with test strips, membranes, and a plastic holder, indicating it is a hardware-based medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states, "The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for in vitro diagnostic and prescription use ONLY." This directly identifies the device as an IVD.
- Device Description: The description details a "lateral flow immunoassay" that analyzes "human urine." This is a common format and sample type for IVD tests.
- Performance Studies: The document describes performance studies comparing the device's results to "GC/MS confirmed values in a blind-labeled clinical specimen correlation study." This type of validation against a reference method using clinical samples is characteristic of IVD devices.
- Key Metrics: The performance metrics listed (Positive Agreement, Negative Agreement, Overall Agreement) are standard metrics used to evaluate the performance of diagnostic tests.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K061718) indicates that this device is being compared to a previously cleared device, which is a process used for regulatory clearance of IVD devices.
N/A
Intended Use / Indications for Use
The Chemtrue® test device is intended for the qualitative detection of drugs of abuse, for in vitro diagnostic use and for prescription use ONLY.
The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow 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 the calibrators used for these drugs are as follows:
Analyte: Benzodiazepines (BZO), Calibrator: Oxazepam, Cutoff Concentration: 300 ng/mL
Analyte: Barbiturates (BAR), Calibrator: Secobarbital/Pentobarbital, Cutoff Concentration: 300 ng/mL
Analyte: Ecstasy (MDMA/XTC), Calibrator: d,I-Methylenedioxymethamphetamine, Cutoff Concentration: 500 ng/mL
Analyte: Methadone (MTD), Calibrator: Methadone, Cutoff Concentration: 300 ng/mL
Analyte: Opiates (OPI/MOR), Calibrator: Morphine, Cutoff Concentration: 2000 ng/mL
Analyte: Oxycodone (OXY), Calibrator: Oxycodone, Cutoff Concentration: 100 ng/mL
The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for in vitro diagnostic and prescription use ONLY. They are not intended for point-of-care settings or over the counter use. These assays provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay 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)
JXM, DIS, DJC, DJR, DJG
Device Description
The Chemtrue® Single/Multi-Panel Drug Screen Dip Card / Cassette Tests, contain 1 to 6 of the following DOA test(s) in each device:
- Benzodiazepines (BZO) test strip
- Barbiturates (BAR) test strip
- Ecstasy (MDMA/XTC) test strip
- Methadone (MTD) test strip
- Opiates /Morphine (OPI/MOR/MOP) cut-off: 2000ng/mL test strip
- Oxycodone (OXY) test strip
The Drugs of Abuse (DOA) Screen Panels are one-step lateral flow immunoassays in which chemically modified drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may 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 anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane.
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 ONLY. Not intended for point-of-care settings or over the counter use. Professional 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
The performance characteristics were evaluated with GC/MS confirmed values in a blind-labeled clinical specimen correlation study. Samples with drug concentration above the cut-off level were considered presumptive positive and concentration below the cut-off were considered negative.
For the Chemtrue® Drug Screen Dip Card Test results versus GC/MS values of the clinical specimens:
BZO: 203 clinical specimens
BAR: 190 clinical specimens
MDMA: 101 clinical specimens
MTD: 104 clinical specimens
OPI(MOR)2000: 106 clinical specimens
OXY: 106 clinical specimens
For the Chemtrue® Drug Screen Cassette Test results versus the GC/MS values of the clinical specimens:
BZO: 203 clinical specimens
BAR: 190 clinical specimens
MDMA: 101 clinical specimens
MTD: 104 clinical specimens
OPI(MOR)2000: 106 clinical specimens
OXY: 106 clinical specimens
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison (Accuracy) study of Chemtrue® Drug Screen Dip Card Test results versus GC/MS values of the clinical specimens (standalone performance):
- BZO: Positive Agreement: 116/118 = 98.3%, Negative Agreement: 84/85 = 98.8%, Overall Agreement: 200/203 = 98.5%
- BAR: Positive Agreement: 103/105 = 98.1%, Negative Agreement: 84/85 = 98.8%, Overall Agreement: 187/190 = 98.4%
- MDMA: Positive Agreement: 40/41 = 97.6%, Negative Agreement: 59/60 = 98.3%, Overall Agreement: 99/101 = 98%
- MTD: Positive Agreement: 44/44 = 100%, Negative Agreement: 59/60 = 98.3%, Overall Agreement: 103/104 = 99%
- OPI(MOR)2000: Positive Agreement: 41/41= 100%, Negative Agreement: 65/65= 100%, Overall Agreement: 106/106= 100%
- OXY: Positive Agreement: 47/47 = 100%, Negative Agreement: 58/59= 98.3%, Overall Agreement: 105/106= 99.1%
Method comparison (Accuracy) study of Chemtrue® Drug Screen Cassette Test results versus the GC/MS values of the clinical specimens (standalone performance):
- BZO: Positive Agreement: 116/118 = 98.3%, Negative Agreement: 84/85= 98.8%, Overall Agreement: 200/203 = 98.5%
- BAR: Positive Agreement: 103/105= 98.1%, Negative Agreement: 84/85= 98.8%, Overall Agreement: 187/190= 98.4%
- MDMA: Positive Agreement: 40/41= 97.6%, Negative Agreement: 59/60 = 98.3%, Overall Agreement: 99/101 = 98%
- MTD: Positive Agreement: 44/44 = 100%, Negative Agreement: 59/60 = 98.3%, Overall Agreement: 103/104 = 99%
- OPI(MOR)2000: Positive Agreement: 41/41= 100%, Negative Agreement: 65/65= 100%, Overall Agreement: 106/106= 100%
- OXY: Positive Agreement: 47/47 = 100%, Negative Agreement: 58/59= 98.3%, Overall Agreement: 105/106= 99.1%
The results demonstrate Chemtrue® Single/ Multi-Panel Drug Screen Test to be substantially in agreement with the GC/MS assigned values.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics reported as Positive Agreement, Negative Agreement, and Overall Agreement:
For Dip Card Test:
- BZO: Positive Agreement = 98.3%, Negative Agreement = 98.8%, Overall Agreement = 98.5%
- BAR: Positive Agreement = 98.1%, Negative Agreement = 98.8%, Overall Agreement = 98.4%
- MDMA: Positive Agreement = 97.6%, Negative Agreement = 98.3%, Overall Agreement = 98%
- MTD: Positive Agreement = 100%, Negative Agreement = 98.3%, Overall Agreement = 99%
- OPI(MOR)2000: Positive Agreement = 100%, Negative Agreement = 100%, Overall Agreement = 100%
- OXY: Positive Agreement = 100%, Negative Agreement = 98.3%, Overall Agreement = 99.1%
For Cassette Test:
- BZO: Positive Agreement = 98.3%, Negative Agreement = 98.8%, Overall Agreement = 98.5%
- BAR: Positive Agreement = 98.1%, Negative Agreement = 98.8%, Overall Agreement = 98.4%
- MDMA: Positive Agreement = 97.6%, Negative Agreement = 98.3%, Overall Agreement = 98%
- MTD: Positive Agreement = 100%, Negative Agreement = 98.3%, Overall Agreement = 99%
- OPI(MOR)2000: Positive Agreement = 100%, Negative Agreement = 100%, Overall Agreement = 100%
- OXY: Positive Agreement = 100%, Negative Agreement = 98.3%, Overall Agreement = 99.1%
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.
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
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).
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Image /page/0/Picture/0 description: The image shows the word "chemtron" in a stylized font. The "c" is enclosed in a partial circle, and there is a line above the "em" portion of the word. The text is in black and the background is white. The font appears to be a serif font.
CHEMTRON BIOTECH, INC 8370 Juniner Creek Lane, 8 AN DIEGO. CA 92126 (858) 530-2868 AX (858) 530-2878 ww.uschemtronbio.co
SEP 1 4 2011
510(k) Summary
AS REQUIRED BY 21 CFR 807.92(c)
The Assigned 510(k) number is K111322
Date of Summary: September 11th, 2011
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:
-
- Benzodiazepines (BZO) test strip
-
- Barbiturates (BAR) test strip
-
- Ecstasy (MDMA/XTC) test strip
-
- Methadone (MTD) test strip
-
- Opiates /Morphine (OPI/MOR/MOP) cut-off: 2000ng/mL test strip
-
- Oxycodone (OXY) 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 FAX: (858) 530-2878
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Substantial Equivalency:
The Chemtrue® Single/Multi-Panel Drug Screen Test is substantially equivalent to other tests currently on the market.
| Test Analyte | Predicate Device Name | Predicate Device
510(k) # |
|------------------------|---------------------------------------------|------------------------------|
| Benzodiazepines | ACON (Alere) One Step Drug Screen Test Card | K061718 |
| Barbiturates | ACON (Alere) One Step Drug Screen Test Card | K061718 |
| Ecstasy (MDMA) | ACON (Alere) One Step Drug Screen Test Card | K061718 |
| Methadone | ACON (Alere) One Step Drug Screen Test Card | K061718 |
| Opiates (Morphine)2000 | ACON (Alere) One Step Drug Screen Test Card | K061718 |
| Oxycodone | ACON (Alere) One Step Drug Screen Test Card | K061718 |
The predicate kit package insert is enclosed in ATTACHMENT A of this submission.
Proposed Labeling or Promotional Material for the Device:
A 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. such as 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 the qualitative detection of drugs of abuse, for in vitro diagnostic use and for prescription use ONLY.
The test provides only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay 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 Scientific Principles
The Drugs of Abuse (DOA) Screen Panels are one-step lateral flow immunoassays in which chemically modified drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may 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
2
conjugate is striped on the test band of the membrane - known as the test region (T) and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane. In the absence of drugs in the urine, the solution of the colored antibodycolloidal gold conjugates moves along with the sample solution by capillary action across the membrane to the immobilized drug-protein conjugate zone 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 of the subject drugs of abuse 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 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 should be discarded. The presence of this colored band in the control region also serves: 1) as verification that adequate specimen volume is added, or no flow, due to insufficient urine volume, 2) to indicate that the test device is properly functioning, and 3) as an internal quality control of the system.
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: Benzodiazepines, Barbiturates, Ecstasy (MDMA), Opiates (Morphine) 2000, Methadone and Oxycodone test from other manufacturers such as ACON (Alere), Alfa Scientific Designs, Inc. All of these products are based on the same technological characteristics, scientific principle and similar procedures. The similarities and differences among 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 Prescription, In Vitro Diagnostic Use Only | Same | ||
| Specimen | Urine | Same | |
| Technological Characteristics and | |||
| Principle | One-Step lateral flow competitive | ||
| Immunoassay | Same |
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| Positive result | 1 colored line | Same | |
|---|---|---|---|
| Device Design/ | |||
| Performance | Negative result | 2 colored lines | Same |
| Detection reagent | Colloidal gold | Same | |
| Accuracy | |||
| Assessment | Confirm with GC/MS reference method | Same | |
| Cut-off | Benzodiazepines 300 ng/mL | Same | |
| Barbiturates 300 ng/mL | Same | ||
| Ecstasy (MDMA) 500 ng/mL | Same | ||
| Methadone 300 ng/mL | Same | ||
| Opiates(Morphine) 2000 ng/mL | Same | ||
| Oxycodone 100 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 ease of use. | Urine specimen needs to be centrifuged, | |
| filtered, or allowed to settle to obtain clear | ||
| specimen for testing. | ||
| Time To Read Result | 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/assay 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 kit ACON's (INNOVACON/Alere) One Step Single and Multi Drug Screen test card product which is currently distributed commercially.
The Chemtrue® Drug Screen Tests do not require pre-treatment for urine specimen, thereby making it much simpler and convenient for the intended user. With regarding to the difference of Time to read result, since the device labeling clearly indicates the required "Read Time", it does not impact the result interpretation by the intended user.
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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 immunoassays for the rapid, qualitative detection of Benzodiazepines, Barbiturates, Ecstasy (MDMA), Opiates (Morphine) 2000, Methadone and Oxycodone in human urine. They are intended for Professional Use and Prescription Use ONLY.
For BAR or BZO test, it may vield preliminary positive results when BAR or BZO is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate and benzodiazepine in urine. The Chemtrue® Single / Multi-Pane drugs of abuse urine test device shows the drug was or was not present at the cutoff level.
The assay provides a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed assay result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory result. Clinical and professional judgment must be applied to any drugs of abuse test result, particularly when preliminary positive results are obtained.
Chemtrue® Single /Multi-Panel Drug Screening Tests vs GC/MS Reference Method
Samples with drug concentration above the cut-off level were considered presumptive positive and concentration below the cut-off were considered negative.
| Table 1. The data are a summary from a method comparison (Accuracy) study of | |||
|---|---|---|---|
| Chemtrue® Drug Screen Dip Card Test results versus GC/MS values of the | |||
| clinical specimens |
| Test | Positive Agreement | Negative Agreement | Overall Agreement |
|---|---|---|---|
| BZO | 116/118 = 98.3% | 84/85 = 98.8% | 200/203 = 98.5% |
| BAR | 103/105 = 98.1% | 84/85 = 98.8% | 187/190 = 98.4% |
| MDMA | 40/41 = 97.6% | 59/60 = 98.3% | 99/101 = 98% |
5
| MTD | 44/44 = 100% | 59/60 = 98.3 % | 103/104 = 99% |
|---|---|---|---|
| OPI(MOR)2000 | 41/41= 100% | 65/65= 100% | 106/106= 100% |
| OXY | 47/47 = 100% | 58/59= 98.3% | 105/106= 99.1% |
Table 2. The data are a summary of a method comparison (Accuracy) study of Chemtrue® Drug Screen Cassette Test results versus the GC/MS values of the clinical specimens
| Test | Positive Agreement | Negative Agreement | Overall Agreement |
|---|---|---|---|
| BZO | 116/118 = 98.3% | 84/85= 98.8% | 200/203 = 98.5% |
| BAR | 103/105= 98.1% | 84/85= 98.8% | 187/190= 98.4% |
| MDMA | 40/41= 97.6% | 59/60 = 98.3% | 99/101 = 98% |
| MTD | 44/44 = 100% | 59/60 = 98.3 % | 103/104 = 99% |
| OPI(MOR)2000 | 41/41= 100% | 65/65= 100% | 106/106= 100% |
| OXY | 47/47 = 100% | 58/59= 98.3% | 105/106= 99.1% |
Conclusion:
The product performance characteristics of were evaluated with the GC/MS confirmed values in a blind-labeled clinical specimen correlation study. The results of these studies demonstrate Chemtrue® Single/ Multi-Panel Drug Screen Test to be substantially in agreement with the GC/MS assigned values.
Additionally, the Chemtrue® Single/ Multi-Panel Drug Screen tests were shown to be equivalent, when compared to the data in the package insert of the predicate kit ACON (INNOVACON/Alere) One Step Drug Screen test card. These results demonstrated that Chemtrue® Single/ Multi-panel Drug Screen cassette and Dip Card are safe and effective in detecting Benzodiazepines, Barbiturates, Ecstasy (MDMA), Methadone, Opiates (Morphine) 2000 and Oxycodone in human urine.
Other non-clinical performance data, such as cutoff characteristics, precision (Reproducibility), specificity (Cross-reactivity and interference) and stability studies are summarized in the Section labeled "Performance Characteristics" and the raw data are enclosed in ATTACHMENT E and ATTACHMENT H of this submission.
510(k) Summary was revised By: Jane Zhang on September 110, 2011
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest feathers. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Chemtron Biotech. Inc. c/o Jane Zhang 8370 Juniper Creek Lane Suite 1-2 San Diego, CA 92126
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
SEP 1 4 2011
Re: k!11322 Trade/Device Name: Chemtrue Single/Multi-Panel Drug Screen Casseue and Dip Card Tests Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: Class H Product Code: JXM. DIS. DJC. DJR. DJG Dated: August 18. 2011 Received: August 19. 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 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.
If your device is classified (see above) into either class II (Special Controls) or class 111 (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, 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parl 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its liternet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm.
Sincerely yours,
jz
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K111322
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 lateral flow 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 the calibrators used for these drugs are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration |
|---|---|---|---|
| Benzodiazepines | BZO | Oxazepam | 300 ng/mL |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 ng/mL |
| Ecstasy | MDMA/XTC | d,I-Methylenedioxymethamphetamine | 500 ng/mL |
| Methadone | MTD | Methadone | 300 ng/mL |
| Opiates | OPI/MOR | Morphine | 2000 ng/mL |
| Oxycodone | OXY | Oxycodone | 100 ng/mL |
The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for in vitro diagnostic and prescription use ONLY. They are not intended for point-of-care settings or over the counter use. These assays provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay 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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Asso
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111322