(318 days)
Not Found
No
The device is described as a rapid chromatographic immunoassay that provides visual qualitative test results without the use of an instrument. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML.
No
The device is a rapid chromatographic immunoassay for detecting drugs in urine; it is used for diagnostic purposes and does not provide therapy.
Yes
The device is described as a "rapid chromatographic immunoassay for the qualitative and simultaneous detection of elevated levels of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline in human urine...". It provides "preliminary analytical test results" for drugs of abuse, which is a diagnostic function.
No
The device is a rapid chromatographic immunoassay integrated into a plastic cup, which is a physical device for collecting and testing urine. It relies on chemical reactions on test strips, not software processing.
Based on the provided text, the Bionexia OptiCup is indeed an IVD (In Vitro Diagnostic) device. Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and simultaneous detection of elevated levels of [various drugs] in human urine." This involves testing a biological sample (urine) in vitro (outside the body) to gain diagnostic information (presence of drugs).
- Device Description: The description details a "rapid chromatographic immunoassay," which is a common type of IVD test. It also describes the device as being used to "run the test" on a urine specimen.
- Regulatory Context: The mention of being "derived from a previously FDA-cleared device" (K061005) strongly suggests it falls under the purview of FDA regulation for medical devices, which includes IVDs.
- Nature of the Test: The test analyzes the chemical composition of a biological sample (urine) to detect specific substances (drugs). This is a hallmark of IVD testing.
Therefore, the Bionexia OptiCup fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bionexia OptiCup is a rapid chromatographic immunoassay for the qualitative and simulaneous detection of elevated levels of Marijuana, Cocaine, Pheney, for the qualitative and simultaneous detection of elevated levels of Marjiuna, Cocaine Methamphetamine, Methadone, Amphetamine, Barbiturates, Carbiturates, Nortriptyline in human urine at or above the following concentrations:
| Marijuana | 50 ng/mL |
|---|---|
| Cocaine | 300 ng/mL |
| Phencyclidine | 25 ng/mL |
| Morphine | 2,000 ng/mL |
| Methamphetamine | 1,000 ng/mL |
| Methadone | 300 ng/mL |
| Amphetamine | 1,000 ng/mL |
| Barbiturates | 300 ng/mL |
| Benzodiazepines | 300 ng/mL |
| Nortriptyline | 1,000 ng/mL |
The Bionexia OptiCup is used to obtain visual qualitative test results and is intended for healthcare professionals only. It is not intended for over the counter sale to non-professionals.
Configurations of the Bionexia OptiCup can consist of any combination of the above listed drug analytes.
This device provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical considerations 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)
LDJ, DIO, LCM, DNK, DKZ, DJR, DJC, DIS, JXM, LFG
Device Description
Bionexia OptiCup is derived from a previously FDA-cleared device, ADT's ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels (K061005).
The unmodified test is made of various number of single drug-of-abuse (DOA) test strips (from 1 to 10 strips) placed in an open faced housing. These test strips are fixed in position with an adhesive label covering over the absorbent end of the test card with dipping end protruding. When running the test, the dipping end of the test panel is dipped into urine sample and test results read at 5 minutes.
The test strips used in Bionexia OptiCup are made in the exact same manner as the strips used in the cleared ACCUSTEP Single and Multi-Strip Dipstick DOA Screen Panels from one to ten single test strips placed in an open-faced housing inside a plastic cup. In Bionexia OptiCup, these test strips are assembled and fixed in position with an adhesive label covering over the absorbent end of the test card with dipping end protruding. The dipstick assembly is then sealed, (integrated) into a plastic urine cup, which also serves as a urine collection and specimen delivering device to run the test in one integrated device.
Bionexia OptiCup is a user-friendly modification of the unmodified device. To use an unmodified device, user has to collect urine sample in a container, tear open the dipstick device pouch, take off the device cover, dip the device into urine sample and hold it for 5-10 seconds, cover the dipstick device cover, lay device flat and wait for 5 minutes to read the preliminary qualitative test results. To use a modified device, user can open the cup pouch and take out the integrated OptiCup, simultaneously collect, dispense urine for dipping, run the test and obtain preliminary qualitative test results in 5 minutes. The leftover urine specimen in the cup, which is not adulterated or tampered with in any way, can be sent in to a toxicology lab for confirmation especially when a presumptive positive test result is obtained. This modified device allows user to administrate multiple drug test from urine specimen collection, testing, and result confirmation with one single device.
Bionexia OptiCup presents an ideal and convenient for various testing environments such as hospitals, clinics, workplace pre-employment screening, justice system or court-ordered compliance monitoring and random drug testing. This integrated Cup is designed to accompany available line of drugs of abuse tests from ADT. Customers can choose any combination of the cleared drug of abuse tests and integrated into this cup.
These tests can be performed without the use of an instrument.
A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing Marijuana, Cocaine, Phencyclidine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
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
Used to obtain visual qualitative test results and is intended for healthcare professionals only. It is not intended for over the counter sale to non-professionals.
Bionexia OptiCup presents an ideal and convenient for various testing environments such as hospitals, clinics, workplace pre-employment screening, justice system or court-ordered compliance monitoring and random drug testing.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).
0
510(k) SUMMARY
AUG 2-0 2009
510(k) SUMMARY
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92.
The Assigned 510(k) number is K082977
Submitter:
MK Bio Inc 10239 Flanders Court San Diego, California 92121 Tel: 858-875-1900 Fax: 858-875 1999
FDA Establishment Registration Number: 3002752660
Date:
October 2, 2008
Contact Person:
Jane Zhang
Product Name:
Bionexia OptiCup
Common Name:
Single-drug lateral flow immunochromatographic test for the simultaneous and qualitative detection of Marijuana, Cocaine, Phencyclidine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline in urine
Regulation Name:
Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline test systems
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1
Product Code:
| Marijuana | LDJ |
|---|---|
| Cocaine | DIO |
| Phencyclidine Hydrochloride | LCM |
| Morphine | DNK |
| Methamphetamine | DKZ |
| Methadone | DJR |
| Amphetamine | DJC |
| Barbiturates | DIS |
| Benzodiazepines | JXM |
| Nortriptyline | LFG |
Classification Number:
| Marijuana | 21 CFR § 862.3870 |
|---|---|
| Cocaine | 21 CFR § 862.3250 |
| Phencyclidine Hydrochloride | 21 CFR § 862.3100 |
| Morphine | 21 CFR § 862.3640 |
| Methamphetamine | 21 CFR § 862.3610 |
| Methadone | 21 CFR § 862.3620 |
| Amphetamine | 21 CFR § 862.3100 |
| Barbiturates | 21 CFR § 862.3150 |
| Benzodiazepines | 21 CFR § 862.3170 |
| Nortriptyline | 21 CFR § 862.3910 |
Device Classification:
Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, The Marijuana, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline test systems have been classified as Class II devices with moderate complexity.
The Bionexia OptiCup is similar to other FDA-cleared devices for the qualitative and simultaneous detection of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline in human urine.
2
Intended Use:
The Bionexia OptiCup is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of elevated levels of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline in human urine at or above the following concentrations:
| Marijuana | 50 ng/mL |
|---|---|
| Cocaine | 300 ng/mL |
| Phencyclidine | 25 ng/mL |
| Morphine | 2,000 ng/mL |
| Methamphetamine | 1,000 ng/mL |
| Methadone | 300 ng/mL |
| Amphetamine | 1,000 ng/mL |
| Barbiturates | 300 ng/mL |
| Benzodiazepines | 300 ng/mL |
| Nortriptyline | 1,000 ng/mL |
The Bionexia OptiCup is used to obtain visual qualitative test results and is intended for healthcare professionals only. It is not intended for over the counter sale to non-professionals.
Configurations of the Bionexia OptiCup can consist of any combination of the above listed drug analytes.
This device provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Description:
Bionexia OptiCup is derived from a previously FDA-cleared device, ADT's ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels (K061005).
The unmodified test is made of various number of single drug-of-abuse (DOA) test strips (from 1 to 10 strips) placed in an open faced housing. These test strips are fixed in position with an adhesive label covering over the absorbent end of the test card with dipping end protruding. When running the test, the dipping end of the test panel is dipped into urine sample and test results read at 5 minutes.
3
The test strips used in Bionexia OptiCup are made in the exact same manner as the strips used in the cleared ACCUSTEP Single and Multi-Strip Dipstick DOA Screen Panels from one to ten single test strips placed in an open-faced housing inside a plastic cup. In Bionexia OptiCup, these test strips are assembled and fixed in position with an adhesive label covering over the absorbent end of the test card with dipping end protruding. The dipstick assembly is then sealed, (integrated) into a plastic urine cup, which also serves as a urine collection and specimen delivering device to run the test in one integrated device.
Bionexia OptiCup is a user-friendly modification of the unmodified device. To use an unmodified device, user has to collect urine sample in a container, tear open the dipstick device pouch, take off the device cover, dip the device into urine sample and hold it for 5-10 seconds, cover the dipstick device cover, lay device flat and wait for 5 minutes to read the preliminary qualitative test results. To use a modified device, user can open the cup pouch and take out the integrated OptiCup, simultaneously collect, dispense urine for dipping, run the test and obtain preliminary qualitative test results in 5 minutes. The leftover urine specimen in the cup, which is not adulterated or tampered with in any way, can be sent in to a toxicology lab for confirmation especially when a presumptive positive test result is obtained. This modified device allows user to administrate multiple drug test from urine specimen collection, testing, and result confirmation with one single device.
Bionexia OptiCup presents an ideal and convenient for various testing environments such as hospitals, clinics, workplace pre-employment screening, justice system or court-ordered compliance monitoring and random drug testing. This integrated Cup is designed to accompany available line of drugs of abuse tests from ADT. Customers can choose any combination of the cleared drug of abuse tests and integrated into this cup.
The Bionexia OptiCup is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of elevated levels of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine. Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriotyline in human urine at or above the following concentrations:
| Marijuana | 50 ng/mL |
|---|---|
| Cocaine | 300 ng/mL |
| Phencyclidine | 25 ng/mL |
| Morphine | 2,000 ng/mL |
| Methamphetamine | 1,000 ng/mL |
| Methadone | 300 ng/mL |
| Amphetamine | 1,000 ng/mL |
| Barbiturates | 300 ng/mL |
| Benzodiazepines | 300 ng/mL |
| Nortriptyline | 1,000 ng/mL |
These tests can be performed without the use of an instrument.
A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing Marijuana,
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4
Cocaine, Phencyclidine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Unmodified Applied DNA Technologies (ADT) Test Device:
The Bionexia OptiCup is derived from a previously FDA cleared device: K061005. This legally marketed but unmodified device and 510(k) number under which it was previously cleared is listed below in Table 1.
| Table 1: Unmodified ADT device with K number and Product Codes | ||||
|---|---|---|---|---|
| -- | ---------------------------------------------------------------- | -- | -- | -- |
| Previously Cleared ADT Drug of Abuse Test | 510(k) Number | Product Code |
|---|---|---|
| ACCUSTEP Single and Multi-Strip DOA Cassette | ||
| and Dipstick Screen Panels | K061005 | LDI, DIO, LCM, LFG, DKZ, |
| DJR, DKZ, DIS, JXM, DJG |
Modified ADT Test Device:
The Bionexia OptiCup is a modified form of a previously FDA-cleared device, K061005. The difference between the modified devices and the unmodified device is that the former has the test strips assembled in a cup format, while the unmodified device has test strips assembled in a dipstick format.
With a cup format, this device can provide many "user friendly" features for the urine-based drug tests. User will be able to collect urine sample, administrate drug test, obtain preliminary test result and send split unadulterated urine sample for confirmation, all with one single drug testing device, the Bionexia OptiCup.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MK Bio. Inc. c/o Ms. Jane Zhang Director of QA/RA 10239 Flanders Court San Diego, CA 92121
AUG 20 2009
Re: K082977
Trade Name: Bionexia OptiCup Regulation Number: 21 CFR §862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Codes: DIO, DIS, DJC, DJR, DNK, DKZ, JXM, LCM, LDJ, LFG Dated: July 16, 2009 Received: July 21, 2009
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 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, 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 Part 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 Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE:
510(K) Number: K082977
Device Name: Bionexia OptiCup
Indications for Use: The Bionexia OptiCup is a rapid chromatographic immunoassay for the qualitative and simulaneous detection of elevated levels of Marijuana, Cocaine, Pheney, for the
qualitative and simultaneous detection of elevated levels of Marjiuna, Cocaine Methamphetamine, Methadone, Amphetamine, Barbiturates, Carbiturates, Nortriptyline in human urine at or above the following concentrations: Benzodiazepines and
| Marijuana | 50 ng/mL |
|---|---|
| Cocaine | 300 ng/mL |
| Phencyclidine | 25 ng/mL |
| Morphine | 2,000 ng/mL |
| Methamphetamine | 1,000 ng/mL |
| Methadone | 300 ng/mL |
| Amphetamine | 1,000 ng/mL |
| Barbiturates | 300 ng/mL |
| Benzodiazepines | 300 ng/mL |
| Nortriptyline | 1,000 ng/mL |
The test strips with an integrated cup is intended for healthcare professionals only. It is not intended for
over the counter sale to non-professionals. over the counter sale to non-professionals.
(Please do not write below this point)
Concurrence of CDRH, Office of In With Delow this point)
Concurrence of CDRH, Office of In Vitro Device Evaluation and Safety
Prescription Use
X
Division Sign-Off
Over-the-counter Use Prescription Use
(Per 21 CFR 801.109)
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082977