(74 days)
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No
The device description details a standard immunochromatographic assay based on antigen-antibody complexation and visual interpretation. There is no mention of AI, ML, image processing, or any computational analysis of the results.
No.
This device is an in-vitro diagnostic test, designed to detect the presence of drugs of abuse and their metabolites in urine, which is for diagnostic purposes, not therapeutic treatment or prevention.
Yes
The device is intended for "qualitative visual tests for five (5) drugs of abuse... in urine sample," and the performance studies section lists sensitivity, specificity, and efficiency against a reference diagnostic device (Hitachi 717 Diagnostic Reagents, Inc EIA), indicating its use in diagnosing the presence of certain substances.
No
The device description clearly outlines a physical dipstrip panel that utilizes immunochromatographic techniques and wicking action with a urine sample. This involves hardware components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Simultaneous qualitative visual tests for five (5) drugs of abuse... in urine sample." This indicates the device is used to examine a sample taken from the human body (urine) to provide information about a person's health status (presence of drugs of abuse).
- Device Description: The description details a test that analyzes a "human urine sample" using an "immunochromatographic technique." This is a common method used in IVD devices to detect specific substances in biological samples.
- Performance Studies: The document describes "Correlation studies" conducted using "human urine samples" to determine the device's performance (sensitivity, specificity, efficiency) in detecting drugs of abuse. This type of testing is characteristic of the validation process for IVD devices.
- Reference Device: The mention of a "Reference Device" (Hitachi 717, Diagnostic Reagents, Inc EIA) which is an EIA (Enzyme Immunoassay) system, further confirms that this device is being compared to another diagnostic testing method.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease.
N/A
Intended Use / Indications for Use
Simultaneous qualitative visual tests for five (5) drugs of abuse: Cocaine, Morphine, Cannabinoids, Methamphetamine and Phencyclidine and their metabolites in urine sample.
Product codes (comma separated list FDA assigned to the subject device)
DIO, LDJ, DJG, DKZ, LCM
Device Description
The Visualine® V Drugs of Abuse Dipstrip Panel test is based on the principle of antigen-antibody complexation and is used for the analysis of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine and their corresponding metabolites in human urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered through a wicking action as the panel (holding the porous membrane) is dipped into the urine sample. The drug in the sample compeics for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Presumptive positive samples (tested on the Hitachi) for each drug were provided by Redwood and tested at Sun Biomedical Labs where blinded studies were conducted to determine the correlation between the two methodologies. Negative samples consisted of UTAK Laboratories Drug Free Urine pool, Lot# 2647, and in-house negative urines tested with Sun Biomedical's Visualine® II product.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Correlation studies between Diagnostic Reagents, Inc. EIA individual assays and Visualine® V dipstrip Panel for Cocaine and it's metabolites, Cannabinoids and it's metabolites, Morphine and it's metabolites, Methamphetamine, and Phencyclidine were conducted at Redwood Toxicology Laboratory, Santa Rosa California and Sun Biomedical Laboratories.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cocaine: Sensitivity 98 %, Specificity >99 %, Efficiency >99 %
Cannabinoids: Sensitivity >99 %, Specificity >99 %, Efficiency >99 %
Morphine: Sensitivity >99 %, Specificity >99 %, Efficiency >99 %
Methamphetamine: Sensitivity >99 %, Specificity >99 %, Efficiency >99 %
Phencyclidine: Sensitivity >99 %, Specificity >99 %, Efficiency >99 %
Reproducibility studies (Cocaine, Cannabinoids, Morphine, Methamphetamine and PCP) indicate:
Within run and run to run > 99 %
Within day and day to day > 99 %
Within lot and lot to lot > 99 %
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.
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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.
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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).
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§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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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DEC 27 1999
SUN BIOMEDICAL LABORATORIES, INC.
604 VPR CENTER, 1001 LOWER LANDING ROAD, BLACKWOOD, NJ 0801 TEL: (609) 401-1080 • FAX: (609) 401-1090 • E-mail: sunlabs@juscom.c
510(k) CONTENT SUMMARY
- Name of Manufacturer:
Sun Biomedical Laboratories, Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, NJ 08012
-
- Trade Name Visualine®V Drugs of Abuse Dipstrip Panel for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine and their metabolites in Human Urine Samples.
-
- Common Name
An in-virro immunoassay test by visual color comparison for the detection of Cocaine. Carnabinoids, Morphine, Methamphetamine, and Phencvclidine in human urine samples,
4. Regulation # and Classification:
Reg. #862-3170, Class II Device
-
- Test Description:
The Visualine® V Drugs of Abuse Dipstrip Panel test is based on the principle of antigen-antibody complexation and is used for the analysis of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine and their corresponding metabolites in human urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered through a wicking action as the panel (holding the porous membrane) is dipped into the urine sample. The drug in the sample compeics for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site.
- Test Description:
1
6. Comparison of Two Test Systems for Correlation Studies:
The Visualine@V Drugs of Abuse Dipstrip Panel for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetamine, and Phencyclidine assay is correlated to the individual Hitachi 717 instrument using Diagnostic Reagents, Inc. material. The following table illustrates the similarities and differences between the two assays.
| | Hitachi 717
(Diagnostic Reagents, Inc EIA) | Visualine®V Drugs of Abuse
Dipstrip Panel for Qualitative
Determination of Cocaine,
Cannabinoids, Morphine,
Methamphetamine, and
Phencyclidine |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Principle | Homogenous enzyme
immunoassay | Competitive binding
immunoassay |
| Sample/Sample Size | 200 uL urine | Approx. 200 ul urine |
| Antibody | Polyclonal and Monoclonal | Polyclonal and Monoclonal |
| Tracer | Drug-Glucose-6-Phosphate
Dehydrogenase | Ab Colloidal Complex |
| Detection Method | Change in absorbance (ΔΑ) value
detected spectrophotometrically | Visual color
precipitin formation |
| Test Run Time | 10-20 minutes, dependent on test | 5 minutes |
| Storage Requirement | 2-8°C (36-46°F) | 2-30°C (36-86°F) |
| Detection Level | Cocaine
300 ng/ml
Cannabinoids
50 ng/ml
Morphine
300 ng/ml
Methamphetamine
1000 ng/ml
Phencyclidine
25 ng/ml | 300 ng/ml
50 ng/ml
300 ng/ml
1000 ng/ml
25 ng/ml |
| Ancillary Equipment | 717 Hitachi Analyzer, EIA
Calibrators | none |
7. Visualine®V Dipstrip Panel Performance Characteristics
- A. Correlation studies between Diagnostic Reagents, Inc. EIA individual assays and Visualine® V dipstrip Panel for Cocaine and it's metabolites, Cannabinoids and it's metabolites, Morphine and it's metabolites, Methamphetamine, and Phencyclidine were conducted at Redwood Toxicology Laboratory, Santa Rosa California and Sun Biomedical Laboratories. Presumptive positive samples (tested on the Hitachi) for each drug were provided by Redwood and tested at Sun Biomedical Labs where blinded studies were conducted to determine the correlation between the two methodologies. Negative samples consisted of UTAK Laboratories Drug Free Urine
2
pool, Lot# 2647, and in-house negative urines tested with Sun Biomedical's Visualine® II product. Correlation with Hitachi 717 yielded the following data:
| Cocaine: | Sensitivity | 49 / 50 | 98 % |
|---|---|---|---|
| Specificity | 247 / 247 | >99 % | |
| Efficiency | 296 / 297 | >99 % | |
| Cannabinoids: | Sensitivity | 50 / 50 | >99 % |
| Specificity | 253 / 253 | >99 % | |
| Efficiency | 303 / 303 | >99 % | |
| Morphine: | Sensitivity | 50 / 50 | >99 % |
| Specificity | 257 / 257 | >99 % | |
| Efficiency | 307 / 307 | >99 % | |
| Methamphetamine: | Sensitivity | 50 / 50 | >99 % |
| Specificity | 255 / 255 | >99 % | |
| Efficiency | 305 / 305 | >99 % | |
| Phencyclidine: | Sensitivity | 50 / 50 | >99 % |
| Specificity | 255 / 255 | >99 % | |
| Efficiency | 305 / 305 | >99 % |
B. Specificity and Substances Detected:
The individual tests are specific to the labeled drug of abuse or structurally related The test detects Cocaine and its metabolites at 300 ng/ml, compounds. Cannabinoids and its metabolites at 50 ng/ml, Morphine and its metabolites at 300 ng/ml, Methamphetamine at 1000 ng/ml and Phencyclidine at 25 ng/ml.
- C. Reproducibility studies for Cocaine, Cannabinoids, Morphine, Precision: Methamphetamine and PCP indicate:
| Within run and run to run | > 99 % |
|---|---|
| Within day and day to day | > 99 % |
| Within lot and lot to lot | > 99 % |
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| 8. Attachments:
| Correlation Studies | (Accuracy) | Section A |
|---|---|---|
| Specificity Studies | (Interference substances and cutoff levels of | |
| Each individual Drug of Abuse) | Section B | |
| Sensitivity Studies | (Analytical studies) | Section C |
| Reproducibility Studies | (Precision) | Section D |
| Visualine® V Dipstrip Panel | ||
| Package Insert | Section E | |
| DRI Inserts for Hitachi 717 | Section F | |
| Label Copies | Section G | |
| Stability Studies | Section H |
:
:
"
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized image of an eagle with three human profiles incorporated into the design of the eagle's neck and head. The eagle is facing to the left.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 7 1999
Ming Sun, Ph.D. President Sun Biomedical Laboratories, Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, New Jersey 08012
Re: K993485
Trade Name: Visualine@ V Drugs of Abuse Dipstrip Panel Regulatory Class: II Product Code: DIO, LDJ, DJG, DKZ, LCM Dated: October 11. 1999 Received: October 14, 1999
Dear Dr. Sun:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1 of
Page__________________________________________________________________________________________________________________________________________________________________________
K 993485 S10(k) Number (if known): _
Visualine V Drugs of Abuse Dipstrip Panel crice Name:_
Indications For Use:
Simultaneous qualitative visual tests for five (5) drugs of abuse: Cocaine, Morphine, Cannabinoids, Methamphetamine and Phencyclidine and their metabolites in urine sample.
Den Cooper
(Division Sign-Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993485
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)