(135 days)
The CEDIA® Buprenorphine assay is a homogenous enzyme immunoassay for qualitative or semi-quantitative determination of the presence of buprenorphine in human urine at cutoff concentration of 5 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The CEDIA® Buprenorphine calibrators are used to calibrate the CEDIA® Buprenorphine Assay in human urine.
The CEDIA® Buprenorphine controls are used to qualify the CEDIA® Buprenorphine Assay 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.
The CEDIA® Buprenorphine Assay uses recombinant DNA technology (US Patent No. 4706929) to produce a unique nomegatiosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These Into two macive ragments no, chily to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, analyte in the sample competes with analyte conjugated to one inactive In the assuy, and you in the bankibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyments free to form active enzyme. If It onluds to antibody, Italibedy binds to analyte conjugated on the inactive andryle is not probent in eassociation of inactive p-galactosidase fragments, and no active fragment, innonting the reassociation ve enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.
This 510(k) premarket notification (K040316) is for the CEDIA® Buprenorphine Assay, a homogenous enzyme immunoassay designed for the qualitative or semi-quantitative determination of buprenorphine in human urine. The information provided focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed data from a specific clinical study with acceptance criteria and device performance results. Instead, it relies on analytical comparisons and functional equivalence to other cleared devices.
Here's a breakdown of the requested information based on the provided text, with acknowledgments where specific details are not available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a typical table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy percentages) for a clinical study comparing the device against a ground truth standard in a test set. Instead, substantial equivalence is claimed based on comparing intended use and physical properties to existing predicate devices, combined with the assumption that similar analytical characteristics will yield similar performance for the stated intended use.
The document states: "The CEDIA® Buprenorphine Assay is substantially equivalent to other CEDIA test system and GC/MS. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information provides reasonable assurance that the CEDIA® Buprenorphine Assay is safe and effective for its stated intended use."
The primary "acceptance criteria" presented are related to the analytical characteristics and intended use being comparable to the predicate devices. The "reported device performance" is essentially that it functions similarly to and provides comparable results to the predicate devices, particularly GC/MS for confirmation.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Qualitative or semi-quantitative determination of buprenorphine | Performs qualitative or semi-quantitative determination of buprenorphine |
| Detects buprenorphine in human urine at cutoff concentration 5 ng/mL | Detects buprenorphine in human urine at cutoff concentration 5 ng/mL |
| Provides a simple and rapid analytical screening procedure | Provides a simple and rapid analytical screening procedure |
| Substantial equivalence to predicate devices (CEDIA DAU 6-Acetylmorphine Assay and GC/MS) in intended use, matrix, and analytical principles. | Demonstrated substantial equivalence in intended use, analyte, matrix, calibrator form, storage, and stability to predicate devices. |
| Effective for its stated intended use | Provides "reasonable assurance that the CEDIA® Buprenorphine Assay is safe and effective for its stated intended use" based on substantial equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify a sample size for a test set of clinical samples. The submission focuses on analytical characteristics and comparison to predicate devices rather than a direct clinical performance study with a test set of patient samples. Therefore, information on data provenance (country of origin, retrospective/prospective) for a test set is not available.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since a specific test set of clinical samples and a corresponding clinical study are not detailed, there is no information provided on the number of experts or their qualifications used to establish ground truth for such a set. The "ground truth" reference in this context is the predicate method, Gas Chromatography/Mass Spectrometry (GC/MS), which is mentioned as the preferred confirmatory method.
4. Adjudication Method for the Test Set
As there is no described test set or clinical study, there is no information on an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This device is an immunoassay for drug detection in urine, not an imaging device or AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not performed or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The CEDIA® Buprenorphine Assay is a standalone laboratory assay (an immunoassay) that provides a preliminary analytical test result. It operates as an algorithm (chemical reaction leading to a spectrophotometric reading to determine the presence and quantity) without human-in-the-loop performance in the sense of AI interpretation. The output is a quantitative or qualitative reading, which then requires human clinical and professional judgment.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document implicitly uses Gas Chromatography/Mass Spectrometry (GC/MS) as the gold standard or "ground truth" for confirming analytical results for buprenorphine. The text states: "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."
8. The Sample Size for the Training Set
The concept of a "training set" in the context of machine learning or AI is not applicable to this immunoassay device. The device's performance is based on its chemical and biological principles, not on a machine learning model trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the typical AI/ML sense, this question is not applicable. The underlying principles of the immunoassay are based on established antibody-antigen reactions and enzymatic activity, which don't require machine learning training data.
§ 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).