(64 days)
The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for drugs of abuse testing. This device is for prescription use only.
The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The device is for prescription use only.
An oral fluid specimen is collected by placing a cellulose pad affixed to a polypropylene stem under the tongue of an individual until a defined volume of saliva has saturated the cellulose pad. The defined volume taken up by the cellulose pad is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then transferred into a polypropylene tube (provided) containing 3 mL of preservative buffer. The tube is stoppered with provided cap. The specimen is ready for storage and transport.
The Quantisal™ Oral Fluid Collection Device collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer contained in the provided transport tube. This results in a 1 to 4 dilution factor.
The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The subject device is substantially equivalent to the predicate device (K200801) as they share the same design, materials, and functionality. The primary difference lies in the updated "Indications for Use" to broaden the scope beyond a specific list of drugs, relying on the established performance data of representative analytes from the predicate device.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance is based on the substantial equivalence to a legally marketed predicate device (K200801) and the device's ability to maintain the stability of various drug analytes in oral fluid samples. The acceptance criteria are implicitly related to maintaining drug stability and collection efficiency demonstrated in the previous submission.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Device Performance | Sample Volume Collected (1 mL) | Performance studies to verify this were submitted and cleared in K200801. |
| Sample Collection Time (until blue dye visible) | Performance studies to verify this were submitted and cleared in K200801. | |
| Drug Recovery (for representative analytes) | Studies performed on representative drug analytes using Quantisal™ Oral Fluid Collection Device were submitted and cleared in K200801. | |
| Oral Fluid Sample Stability (8-25°C) | THC: 10 days; Benzoylecgonine: 10 days; Cocaine: 5 days; Morphine: 10 days; Codeine: 10 days; Oxycodone: 10 days; Hydrocodone: 10 days; 6-acetylmorphine: 10 days; Phencyclidine: 10 days; Amphetamine: 10 days; Methamphetamine: 10 days; Buprenorphine: 10 days; Methadone: 10 days; Benzodiazepines: 10 days; Tramadol: 10 days. | |
| Oral Fluid Sample Stability (2-8°C) | THC: 2 months; Benzoylecgonine: 12 months; Cocaine: 1 month; Morphine: 12 months; Codeine: 12 months; Oxycodone: 12 months; Hydrocodone: 12 months; 6-acetylmorphine: 12 months; Phencyclidine: 12 months; Amphetamine: 12 months; Methamphetamine: 12 months; Buprenorphine: 12 months; Methadone: 12 months; Benzodiazepines: 12 months; Tramadol: 12 months. | |
| Sample Transportation Stability | Studies performed on representative drug analytes using Quantisal™ Oral Fluid Collection Device were submitted and cleared in K200801. | |
| Methodology | Acceptable Analytical Method for Drug Detection and Quantification | Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and Gas chromatography-mass spectrometry (GC-MS) for performance evaluation. |
| Intended Use Generalization | Applicability to "drugs of abuse testing" beyond specific analytes listed | The device demonstrated safety and efficacy for a representative group of analytes (THC, Benzoylecgonine, Cocaine, Morphine, Codeine, Oxycodone, Hydrocodone, 6-acetylmorphine, Phencyclidine, Amphetamine, Methamphetamine, Buprenorphine, Methadone, Benzodiazepines, Tramadol) and their concentrations. This supports generalization, with the caveat that new analytes require validation by the user. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to performance studies submitted and cleared in K200801 for sample volume, collection time, drug recovery, and clinical specimen studies. For the extended refrigerated sample stability, the samples were low positive samples (+50% cutoff). The exact number of samples used for each test (sample size for the test set) is not explicitly stated in this document, as it refers back to the K200801 submission. The provenance of the data (country of origin, retrospective/prospective) and detailed sample sizes are also not provided in this document but would have been part of the K200801 submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the current 510(k) summary. The ground truth for drug detection and quantification would typically be established by the analytical methods themselves (LC-MS/MS, GC-MS), which are considered definitive. Expert interpretation might come into play during method development or result validation, but details are not given here.
4. Adjudication Method for the Test Set
This information is not applicable in the context of analytical device performance studies where objective measurements (e.g., drug concentrations by LC-MS/MS or GC-MS) establish the "ground truth." Adjudication methods like 2+1 or 3+1 are typically used in image-based diagnostic studies involving human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not applicable and therefore not done. This device is an oral fluid collection device, not an AI-assisted diagnostic tool that requires human interpretation. The performance relates to its ability to collect and preserve samples for subsequent laboratory analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the device is a collection device, not an algorithm. Its performance is evaluated based on its physical properties for collection, preservation, and chemical stability of the analytes.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations (drug recovery, stability) was established using definitive analytical methods: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and Gas chromatography-mass spectrometry (GC-MS). These methods are considered the gold standard for identifying and quantifying drugs, serving as the "pathology" equivalent in this context.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. As a physical collection device, it does not rely on machine learning or algorithms that require training data. All mentioned studies are performance evaluations.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.