(193 days)
Not Found
No
The device description details a standard immunochromatographic assay based on competitive binding, which is a chemical process and does not involve AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is a diagnostic tool designed to detect the presence of buprenorphine in urine, not to treat a condition.
Yes
The device qualitatively determines the presence of buprenorphine in human urine, which is a screening procedure to detect a substance in the body, indicating it is used for diagnostic purposes, even if it only provides a preliminary result.
No
The device description clearly describes a physical immunochromatographic strip test device, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of the presence of buprenorphine in human urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro) to diagnose or screen for a condition (presence of buprenorphine).
- Device Description: The description details a laboratory test method (immunochromatographic enzyme immunoassay) performed on a biological sample (urine).
- Predicate Device: The mention of a predicate device (K040316 CEDIA® Buprenorphine Assay) which is also an IVD further supports this classification.
The core function of the device is to analyze a biological sample in vitro to provide information about a person's health status (in this case, the presence of a drug). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For Sure One Step Buprenorphine Strip Test Device is an immunochromatographic enzyme immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
The For Sure One Step Buprenorphine Strip Test Device consists of a chromatographic The For Barevice in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled As the test sumple no we the free drug in the specimen forming an antibody-antigen annoote) - ouslex competes with immobilized antigen conjugate in the Test complex. This one and will not produce a magenta color band when the drug is above the detection level of 10 ng/ml of Buprenorphine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the test line and control area. A POSITIVE specimen produces only one color band in the control area. There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line 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
Not Found
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
§ 862.3650 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
March 30th, 2005 SECTION II 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
51O{k) Number: K042990
Submitter:
Tianjin New Bay Bioresearch Co., Ltd. #3 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianjin, China Telephone: 86-22-28751515 Facsimile: 86-222-875-1516
Contact Person:
Rodrigo Berlie New Product Development Director Telephone: (760) 602-2929 Facsimile: (760) 602-2999
Preparation Date:
March 30, 2005
Device Information:
Device Classification Name: Immunoassay, Buprenorphine Common/Usual Name: Immunoassay Test System for detection of Buprenorphine in Human Urine Proprietary Name: Rapid One Step Strip Buprenorphine Test, For Sure One Step Buprenorphine Strip Test Device Regulation Number: 21 CFR§862.3650 Regulatory Name: Buprenorphine test system Product Code: DJG Regulatory Class: Class II
Predicate Devices:
For Sure One Step Buprenorphine Strip Test Device is substantially equivalent to The CEDIA® Buprenorphine Assay cleared by FDA (K040316), and GC/MS for its stated intended use.
1
Device Description:
The For Sure One Step Buprenorphine Strip Test Device consists of a chromatographic The For Barevice in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled As the test sumple no we the free drug in the specimen forming an antibody-antigen annoote) - ouslex competes with immobilized antigen conjugate in the Test complex. This one and will not produce a magenta color band when the drug is above the detection level of 10 ng/ml of Buprenorphine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the test line and control area. A POSITIVE specimen produces only one color band in the control area. There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Intended Use:
For Sure One Step Buprenorphine Strip Test Device is an immunochromatographic enzyme immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
Comparison to Predicate Device(s):
For Sure One Step Buprenorphine Strip Test Device is substantially equivalent to CEDIA buprenorphine test system cleared by FDA, e.g., the CEDIA Buprenorphine Assay (040316) and GC/MS for its stated intended use.
| Device Characteristics | Subject Device | Predicate Device(s)
CEDIA Buprenorphine Assay
(K040316) and GC/MS |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Buprenorphine one-step
Immunochromatographic test with
10ng/ml cutoff.
The assay provides a simple and rapid
analytical screening procedure to
detect buprenorphine in human urine | The CEDA® Buprenorphine assay is
homogenous enzyme immunoassay
for qualitative or semi-quantitative
determination of the presence of
buprenorphine in human urine at
cutoff concentration of 5 ng/ml. |
| Analyte | Buprenorphine | Buprenorphine |
| Cut Off | 10 ng/ml | 5 ng/ml |
2
| Matrix | Urine | Urine |
|---|---|---|
| Calibrator | None | 5 levels (0,5,20,50 and 75 mg/ml) |
| Instrument | None, Visual read, Single Use | Expensive Auto-analyzer |
| Calibration of Reagent | None | Yes, multiple reagents require |
| calibration. | ||
| Storage | Below 28 °C until expiration | 2°C - 8°C until expiration date |
Summary:
The information provided in this pre-market notification demonstrates that the For Sure One Step Buprenorphine Strip Test Device is substantially equivalent to CEDIA Buprenorphine test assay system and GC/MS.
Dubstantial equivalence was demonstrated through comparison of intended use and Dabbanalar equitation mercially available and analytical predicate devices. The percentation supplied in this pre-market notification provides reasonable assurance that mormation buppens in uprenorphine Strip Test Device is safe and effective for its stated intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 0 2005
Tianjin New Bay Bioresearch Co., Ltd. c/o Mr. Rodrigo Berlie Marketing Director Aviara Biotech, LLC. 2720 Loker Avenue West -Suite U Carlsbad, CA 92008
K042990 Re:
Ro42770
Trade/Device Name: For Sure One Step Buprenorphine Strip Test Device Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: April 28, 2005 Received: May 2, 2005
Dear Mr. Berlie:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your collection in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of to regions and ment date of the Medical Device Amendments, or to conimores 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). and Cosmetic (110. (110.) that be nevice, subject to the general controls provisions of the Act. The I va may, merelove, mains of the Act include requirements for annual registration, listing of general voluled provision 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 it may be subject to Satin Cash Regulations (CFR), Parts 800 to 895. In addition, FDA ean oc found in firther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be devised that I Drivination that your device complies with other requirements of the Act that I Dri has intace a and regulations administered by other Federal agencies. You must of any I cacrated and the Act's requirements, including, but not limited to: registration and listing (21 comply with and 110 (21 CFR Parts 801 and 809); and good manufacturing practice er rant 007), accensed in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter witi anow you to organ maining of substantial equivalence of your device to a legally premainer notificated in ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the vitro Diagnoution De Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain other general 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/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K042990
Device name: For Sure One Step Buprenorphine Strip Test Device
Indications for Use:
For Sure One Step Buprenorphine Strip Test Device is an immunochromatographic I of Sure One Deprenerprints of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative I he assay provides ost ) a used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Chiromatography Amaso op sent should be applied to any drug of abuse test results particularly when preliminary results are used.
Over-The-Counter Use AND/OR Prescription Use X_____________________________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alle & Siel,
ivision Sign-
Office of In Vitro Diagnostic Device Evaluation and Safety
51090 K042990
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