(224 days)
The Quantisal™ II 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 II 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 split collector containing two cellulose pads 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 pads is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then separated into two specific pads/stems (Collector 1 and 2) and transferred into two separate polypropylene tubes (provided) both containing 3 mL of preservative buffer (Labelled A and B). The tubes are stoppered with provided caps. The specimen is ready for storage and transport.
The design of the split collector allows for the simultaneous collection of 2 aliquot to be used for screening and confirmation testing and the other aliquot to be stored as retain sample for potential confirmation testing.
The Quantisal II 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 provided document describes a 510(k) premarket notification for the Quantisal™ II Oral Fluid Collection Device. This device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The submission claims substantial equivalence to a predicate device (K183048).
The document does not describe an AI/ML device. It details the performance characteristics and studies for a medical device designed for specimen collection, specifically an oral fluid collection device. Therefore, many of the requested criteria related to AI/ML device evaluation (like sample size for test/training sets, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance) are not applicable or extractable from this document.
However, I can provide information based on the performance characteristics described for this physical device.
Device: Quantisal™ II Oral Fluid Collection Device
Intended Use: Collection, preservation, and transport of oral fluid specimens for drugs of abuse testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" as a pass/fail threshold in a tabular format for each study outcome. Instead, it describes various performance studies conducted and their positive findings, stating that the device is "substantially equivalent" to the predicate. The performance evaluation is based on demonstrating proper sample collection, preservation, and analytical comparability.
Since no explicit quantitative acceptance criteria are given for the studies, I will list the areas of performance evaluation and the conclusions drawn from the studies.
| Performance Area | Reported Device Performance |
|---|---|
| Sample Volume Collection | Performance studies to verify the sample volume collected were submitted and cleared in K183048. (Implies successful collection of 1 mL neat oral fluid, diluted to 1:4 with 3 mL buffer as described in device description). |
| Sample Collection Time | Performance studies to verify the sample collection time were submitted and cleared in K183048. (Implies collection within the specified up to 10 minutes). |
| Drug Recovery | Drug recovery studies performed on representative drug analytes using the device were submitted and cleared in K183048. (Implies satisfactory recovery of drugs from the collected sample). |
| Borosilicate Glass Vial Stability | Study performed to verify the borosilicate glass vial acts as "analytical truth" and does not affect drug concentrations. Results were submitted and cleared in K183048. (Implies the vial is suitable for its purpose). |
| Oral Fluid Sample Stability | - Evaluated with low positive samples (+50%) for representative drugs. |
- Results: Most drugs stable for 10 days at 8-25°C and 12 months at 2-8°C in both A and B specimens. Cocaine stable for 5 days at 8-25°C and 1 month at 2-8°C. THC stable for 10 days at 8-25°C and 2 months at 2-8°C. Measured by comparing concentrations over time to initial concentration, with results within ±10% of initial concentration listed as stable intervals. |
| Sample Transportation Stability | Performed on representative drug analytes and submitted/cleared in K183048. (Implies the device maintains sample integrity during transport). |
| Clinical Specimens Equivalency | - Study demonstrated equivalency between the two collection pads (A and B) of the device. - Forty deidentified, unaltered drug-free clinical oral fluid samples and up to forty deidentified, unaltered clinical oral fluid samples containing representative drugs were collected by expectoration and with the Quantisal II device.
- Results: Quantisal II Tube "A" and "B" results were compared to each other, and results from expectorated neat oral fluid and Quantisal II collected samples "matched 100%". |
| Expectorated Oral Fluid Samples Processed Through Quantisal II (Dipping Study) | - Verified that drug concentrations in oral fluid samples collected by the device are analytically comparable to neat oral fluid samples collected by expectoration. - At least 60 oral fluid samples for each representative drug (from self-reported drug user patients) collected by expectoration.
- An aliquot of each expectorated sample was processed through the device by dipping.
- Results: 899/900 Quantisal II Oral Fluid Collection Device samples had concentrations that were within ±20% of expectoration concentration. |
2. Sample Size and Data Provenance
Again, this is not an AI/ML device study. The provided data relates to a physical device for sample collection.
- Test Set Sample Size:
- Oral Fluid Sample Stability: Not explicitly stated as a "test set" size, but samples were evaluated for each representative drug at low positive concentrations. The table shows initial concentrations for 14 drugs.
- Clinical Specimens Equivalency: At least 40 deidentified, unaltered drug-free clinical oral fluid samples and up to 40 deidentified, unaltered clinical oral fluid samples containing representative drugs.
- Dipping Study: At least 60 oral fluid samples for each of the 14 representative drugs listed in Table 5-2. (This implies a minimum of 14 drugs * 60 samples = 840 samples). The combined result mentioned "899/900 Quantisal II Oral Fluid Collection Device samples".
- Data Provenance: Clinical research facilities. The document does not specify the country of origin but implies clinical settings where drug users or drug-free individuals provide samples. The studies are retrospective in the sense that they analyze collected samples. The "Clinical Specimens Equivalency" study used "deidentified, unaltered clinical oral fluid samples" collected for comparison.
3. Number of Experts and Qualifications for Ground Truth
Not applicable to this type of device study. The ground truth for drug concentrations was established using analytical gold standards (LC-MS/MS and GC-MS), not human expert consensus.
4. Adjudication Method for the Test Set
Not applicable, as this is not an AI/ML device study requiring human adjudication of results. Analytical methods (LC-MS/MS, GC-MS) were used for quantitative comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML or imaging interpretation device. There are no "human readers" involved in the primary function or evaluation of this oral fluid collection device.
6. Standalone (Algorithm Only) Performance
Not applicable, as this is a physical medical device and not an algorithm or software. The performance assessed is the device's ability to collect and preserve samples reliably for subsequent laboratory analysis.
7. Type of Ground Truth Used
The ground truth for the performance studies was established through:
- Analytical Gold Standards: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and Gas Chromatography—Mass Spectrometry (GC-MS) were used to quantify drug concentrations in collected samples, serving as the "ground truth" for drug levels.
- Comparisons: "Analytical comparability" to neat oral fluid samples collected by expectoration was also used as a ground truth for assessing collection efficiency. The borosilicate glass vial was also verified to provide "analytical truth."
8. Sample Size for the Training Set
Not applicable, as this is a physical medical device and not an AI/ML algorithm that undergoes a training phase.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this physical device.
§ 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.