(56 days)
The Bionike One Step Opiate(Morphine) Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of morphine and its metabolites at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.
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This is a 510(k) clearance letter for the Bionike AQ™ Opiates (morphine) Test, which is an in vitro diagnostic device. The letter determines substantial equivalence to a predicate device, allowing the sale of the device.
Based on the provided document, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific acceptance criteria or report detailed device performance metrics (e.g., sensitivity, specificity, accuracy) in a tabular format as would be found in a study summary.
However, the "Indications for Use" section (page 2) provides a key piece of information that can be inferred as a performance parameter:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cutoff concentration for opiate (morphine) detection | 300 ng/mL |
Note: This is a very limited interpretation as the document is a clearance letter, not a detailed study report. The 300 ng/mL value is a threshold for detection, not a performance metric like sensitivity or specificity. A full study report would include those details.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not contain any information regarding:
- The sample size used for the test set.
- The data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided document does not contain any information regarding:
- The number of experts used to establish ground truth.
- The qualifications of those experts.
4. Adjudication Method for the Test Set
The provided document does not contain any information regarding the adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The provided document does not contain any information indicating that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect sizes related to human reader improvement with or without AI assistance. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device described is an "immunochromatographic competitive assay." This is a laboratory test, not an algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI/ML devices is not directly applicable here. The test itself is a standalone diagnostic tool once run by a healthcare professional, providing a preliminary analytical result without real-time human interpretation within the test mechanism.
The document states: "The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only." This indicates the device acts as a standalone screening tool that requires subsequent confirmatory testing and professional interpretation.
7. The Type of Ground Truth Used
The ground truth for detecting opiates (morphine) in urine, as hinted by the document, would be the results from a confirmatory method. The document explicitly states: "The test... provides only a preliminary analytical result which must be confirmed using GC/MS."
Therefore, the type of ground truth used for validation would likely be Gas Chromatography/Mass Spectrometry (GC/MS), which is a highly accurate and commonly accepted gold standard for drug confirmation in toxicology.
8. The Sample Size for the Training Set
The provided document does not contain any information regarding the sample size for the training set. This is consistent with a medical device 510(k) clearance letter for an in vitro diagnostic test rather than an AI/ML device that requires explicit training data.
9. How the Ground Truth for the Training Set Was Established
Since this is not an AI/ML device, the concept of a "training set" in the context of machine learning does not apply. If there were any "training" or development involved for the assay characteristics before the pivotal study, the ground truth would still likely have been established using a highly accurate confirmatory method like GC/MS to ensure the assay's performance characteristics (like the 300 ng/mL cutoff) were correctly set. However, the document does not elaborate on this.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 6 1997
Janis Freestone Director, Regulatory Affairs Bionike, Inc. 1015 Grandview Drive So. San Francisco, California 94080-4910
Re: K971361 Bionike AQ™ Opiates (morphine) Test Requlatory Class: II Product Code: DJG Dated: April 10, 1997 Received: April 11, 1997
Dear Ms. Freestone:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labelinq, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 requlations.
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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 leqally 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/dsmamain.html".
Sincerely yours,
Steven Litman
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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510k Number:__________________________________________________________________________________________________________________________________________________________________
Device Name: Bionike One Step Opiate (Morphine) Test
Indications for Use:
The Bionike One Step Opiate(Morphine) Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of morphine and its metabolites at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.
K971361
(Division
Division of Clinical Laboratory Devices
510(k) Number
K971361
§ 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).