(358 days)
The RapidSense™ Drugs of Abuse Cocaine (COC) 300 Device is a lateral flow competitive immunoassay intended for the qualitative detection for the cocaine metabolite, benzoylecgonine, in human urine at a cut-off concentration of 300 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For In Vitro Diagnostic Use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a cocaine metabolite specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
The RapidSense™ Drugs of Abuse Cocaine (COC) 300 Device is an immunoassay based on the principle of competitive binding. The cocaine metabolite, benzoylecgonine, which may be present in the urine specimen competes against its respective drug conjugate for binding sites on the specific antibody. The assay is a colored-latex particle, monoclonal antibody-based rapid test for the qualitative detection of the cocaine metabolite at a cut-off of 300 ng/mL. The test utilizes the QuantRx patented, one step positive read, competitive immunoassay technology.
In the absence of the drug in the urine or if the amount of drug is below cut-off level, the visible test line zone (T) will show a clean negative (no signal on the test band). Drug positive specimens show a blue line in the visible test line zone (T). As an internal procedural control, a red control line appears in the control region (C) to verify that sufficient volume of sample was added and proper flow was obtained. The control line should always appear regardless of the presence of the drug if the assay has been performed properly.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance (RapidSense™ vs. GC/MS) |
|---|---|
| Sufficient positive agreement with GC/MS | 91.1% (41/45) (95% CI: 79.3% - 96.5%) |
| Sufficient negative agreement with GC/MS | 95.2% (40/42) (95% CI: 84.2% - 98.7%) |
| Sufficient total agreement with GC/MS | 93.1% (81/87) (95% CI: 85.8% - 96.8%) |
| Similar performance to predicate device | Reported as "similar performance" |
Note: The document doesn't explicitly state numerical acceptance criteria thresholds. Instead, it presents the performance and concludes that these results "demonstrate the substantial equivalence." The implied acceptance criteria are that the device's performance should be high enough to be considered substantially equivalent to a legally marketed predicate device and to the recognized reference method (GC/MS).
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: 85 specimens
- Data Provenance: "previously collected from subjects presenting for drug testing by an external laboratory." This indicates the data is retrospective. The country of origin is not explicitly stated, but the submission is to the US FDA, suggesting it's likely from the US or a region with comparable clinical practices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The ground truth for the test set (accuracy study) was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided. The ground truth for the test set was established by GC/MS, an objective chemical analysis, not human interpretation requiring adjudication.
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 is not applicable. This device is an in-vitro diagnostic (IVD) device (a laboratory test), not an imaging or interpretation device that would involve human readers or AI assistance in the way an MRMC study typically assesses. The device provides a qualitative "positive" or "negative" result.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the accuracy study comparing the RapidSense™ device to GC/MS is a standalone performance study. The device itself, without human interpretation of complex images or data, provides the result directly from the urine sample. Human professionals simply read the yes/no result from the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for the accuracy study was Gas Chromatography/Mass Spectrometry (GC/MS). This is considered a gold standard analytical method for confirming the presence and concentration of drugs and their metabolites in biological samples.
8. The sample size for the training set:
This information is not provided in the document. As an immunoassay, the "training set" concept (as understood for machine learning algorithms) doesn't directly apply in the same way. The device's performance relies on its physical and chemical design, manufacturing, and calibration, rather than an algorithm trained on a dataset.
9. How the ground truth for the training set was established:
This information is not provided and is not directly applicable in the sense of a machine learning training set. The "ground truth" for the development and calibration of such an immunoassay would typically involve testing known positive and negative samples, as well as samples spiked with known concentrations of the analyte, to optimize the assay's sensitivity and specificity around the specified cut-off. This process isn't detailed in the 510(k) summary.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).