(62 days)
No
The device description and performance studies focus on immunochromatography and chemical reactions, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic test designed to detect opiates in urine, not to treat or cure a disease or condition.
Yes
The device is designed for the "qualitative determination of Opiates and its metabolites in human urine specimens," which is a form of in vitro diagnostic testing to identify the presence of substances indicative of a condition or exposure.
No
The device description clearly indicates it is an immunochromatography-based in vitro test using physical test cards/strips and chemical reactions to detect substances in urine, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro test" and is designed for the "qualitative determination of Opiates and its metabolites in human urine specimens." This clearly indicates it is used to test samples taken from the human body outside of the body.
- Device Description: The description details the mechanism of the test, which involves "specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen." This is a common method used in IVD tests.
- Intended User/Care Setting: While it's for "professional use," this is a common characteristic of many IVD devices, particularly those used in clinical or laboratory settings.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Rapid Opiates Test Card II is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Opiates and its metabolites in human urine specimens. The presence of Morphine in human urine above a cutoff level of 2,000ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
Product codes
DJG
Device Description
The Rapid Drug tests are based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for antibody binding between drug conjugate and free drug which may be present in the urine specimen being tested.
When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibody-dye conjugate. When the amount of drug is equal or more than the cutoff level, it will prevent the binding of drug conjugate to the antibody. As a result, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine specimen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The studies performed are listed below:
Rapid Opiates Test Strip II Sensitivity Accuracy (comparison study of clinical urine specimens) Stability - Specimen Stability - Product Precision Reproducibility Specificity Interference
Rapid Opiates Test Card II Accuracy (comparison study of clinical urine specimens) Precision Comparison between Rapid Opiates Test Strip II and Test Card II
Both urine control specimen and clinical urine specimen were tested to evaluate the safety and effectiveness of Rapid Opiates Test Strip II and Rapid Opiates Test Card II. The other component strips, Amphetamine, Benzodiazepine, Cocaine, Methamphetamine, Opiates (at 300ng/ml cutoff), Phencyclidine and THC in Multiple Test Panels have received FDA approval in submission K003809 and K003809/A002.
The results of performance characteristics demonstrate Rapid Opiates Test Strip II and Rapid Test Card II to be substantially equivalent to the Applied Biotech SureStep ™Drug Screen Test Morphine II, which received 510 (k) approval.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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
MAY 0 6 2002
K0207/6
510 (k) SUMMARY (21 CFR PART 807.92)
Product
Rapid Opiates Test Strip II, Rapid Opiates Test Card II and DOA Multiple Drug Test Cards (up to six tests).
Name of Manufacturer
Rapid Diagnostics, Inc. 1429 Rollins Road, Burlingame, CA 94010, U.S.A.
Principle
The Rapid Drug tests are based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for antibody binding between drug conjugate and free drug which may be present in the urine specimen being tested.
When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibody-dye conjugate. When the amount of drug is equal or more than the cutoff level, it will prevent the binding of drug conjugate to the antibody. As a result, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result.
Intended Use
The Rapid Drug Tests are immunochromatography based one step in vitro test. It is designed for qualitative determination of Amphetamine, Benzodiazepines, Cocaine, Methamphetamine, Opiates, Phencyclidine and THC in human urine specimen above the following cutoff level:
| Amphetamine | 1000ng/ml |
|---|---|
| Benzodiazepines | 300ng/ml |
| Cocaine | 300ng/ml |
| Methamphetamine | 1000ng/ml |
| Opiates | 300ng/ml |
| Opiates II | 2000ng/ml |
| Phencyclidine | 25ng/ml |
| THC | 50ng/ml |
I. ર
1
Performance
The studies performed are listed below:
Rapid Opiates Test Strip II Sensitivity Accuracy (comparison study of clinical urine specimens) Stability - Specimen Stability - Product Precision Reproducibility Specificity Interference
Rapid Opiates Test Card II Accuracy (comparison study of clinical urine specimens) Precision Comparison between Rapid Opiates Test Strip II and Test Card II
Both urine control specimen and clinical urine specimen were tested to evaluate the safety and effectiveness of Rapid Opiates Test Strip II and Rapid Opiates Test Card II. The other component strips, Amphetamine, Benzodiazepine, Cocaine, Methamphetamine, Opiates (at 300ng/ml cutoff), Phencyclidine and THC in Multiple Test Panels have received FDA approval in submission K003809 and K003809/A002.
The results of performance characteristics demonstrate Rapid Opiates Test Strip II and Rapid Test Card II to be substantially equivalent to the Applied Biotech SureStep ™Drug Screen Test Morphine II, which received 510 (k) approval.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Charles Yu President/Official FDA Correspondent Rapid Diagnostics, Inc. 1429 Rollins Road, Burlingame, CA 94010
MAY 0 6 2002
Re: K020716
Trade/Device Name: Rapid Opiates Test Card II Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: February 18, 2002 Received: March 5, 2002
Dear Mr. Charles Yu:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -
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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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
4
INDICATIONS FOR USE STATEMENT
510 (K) number (if known): K020716
Device Name: Rapid Opiates Test Card II
Indications for Use:
Rapid Opiates Test Card II is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Opiates and its metabolites in human urine specimens. The presence of Morphine in human urine above a cutoff level of 2,000ng/ml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Tean Lopez
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
Prescription Use: (Per 21 CFR 801.109) OR
Over the Counter Use: