(269 days)
The Quantisal II Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), benzoylecgonine, cocaine, oxycodone, hydrocodone, bacetylmorphine, phencyclidine, amphetamine, buprenorphine, methadone, benzodiazepines and tramadol. 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. An oral fluid specimen is collected by placing two cellulose pads affixed to a polypropylene stem (Collector) under the tongue of an individual until a defined volume of saliva has saturated the cellulose pads. 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 and transferred into two separate polypropylene tubes (provided) both containing a specific volume of preservative buffer. The tubes are stoppered with provided caps. The specimens are then ready for storage or transport. The design of two specific pads/stems allows for one aliquot to be used for screening and confirmation testing and the other aliquot to be stored as retain sample for potential second chance testing. The Quantisal II Oral Fluid Collection System collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer. This results in a 1 to 4 dilution factor. Immunalysis Quantisal II Oral Fluid Collection Device is sold as a stand-alone collection device.
This document describes product testing for the Immunalysis Quantisal II Oral Fluid Collection Device, a medical device for collecting and preserving oral fluid samples for drug testing. This is not an AI/ML device, and therefore the details usually associated with an AI/ML device's acceptance criteria and study (such as MRMC studies, human reader improvement with AI assistance, or sample sizes for training sets) are not applicable.
However, based on the provided text, we can extract details regarding the device's performance characteristics and how its acceptance was established.
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sample Volume | Consistency within 15% between collectors A and B | Confirmed consistency of 1 mL collected by each Quantisal II collector, and volume difference between A and B did not exceed 15% (for 50 volunteers and 75 known drug users). |
| Sample Collection Time | Collection time within 10 minutes | Within the claimed time of 10 minutes in over 99% of 125 subjects (50 volunteers and 75 known drug users). |
| Drug Recovery (In Vitro) | >80% of original concentration | Demonstrated >80% recovery of tested drugs. |
| Oral Fluid Sample Extraction Efficiency | Drug recovery >80% at 4 hours, >90% at 24 hours | Drug recovery was >80% at 4 hours post-collection for all drugs and reached >90% at 24 hours for all drugs, indicating complete extraction. |
| Oral Fluid Sample Stability (Ambient) | Stable x days (specific to drug) | 10 days for most drugs, 5 days for Cocaine at 8-25°C. Ongoing for refrigerated. |
| Oral Fluid Sample Stability (Refrigerated) | Stable x days (specific to drug); "B" specimen within 100+/- 10% recovery for 1 month at 2°C - 8°C | 10 days for most drugs at 2-8°C. "B" specimen retained within 100+/- 10% recovery after 1 month storage at 2°C - 8°C. |
| Sample Transportation Stability | Drug concentration within 20% of reference value | Drug concentration within 20% of reference value during 4-day (96 hours) simulated transportation at -20°C to 40°C. |
| Borosilicate Glass Vial Stability | Drug loss within ±10% of initial value after 48 hours at 25°C | Drug loss within ±10% of initial value after 48 hours storage at 25°C. |
| Clinical Specimens (Quantisal II A/B agreement) | Quantisal II A and B samples within ±15% of each other | 100% (e.g., 40/40) for all drug classes/sample types tested. |
| Clinical Specimens (Agreement with Expectorated Samples) | Quantisal II A/B agreement with expectorated samples; no false positives/negatives based on presence/absence of drugs | 100% (e.g., 40/40) for all drug classes/sample types tested. "In no case was the expectorated neat oral fluid positive and the Quantisal II collected samples negative or vice versa." |
| Expectorated Oral Fluid Samples Processed Through Quantisal II (Dipping Study) | Quantisal II A and B concentrations within 15% of each other; Quantisal II concentration within ±20% of expectoration result | 899/900 paired results met the criterion for A and B concentrations within 15% of each other. 899/900 paired results met the criterion for Quantisal II concentration within ±20% of expectoration result. |
2. Sample sizes used for the test set and the data provenance
- Sample Volume: 50 oral fluid samples from volunteers (country not specified, likely US since FDA submission), 75 oral fluid samples from known drug users (country not specified, likely US since FDA submission). Retrospective.
- Sample Collection Time: 50 oral fluid samples from volunteers, 75 oral fluid samples from known drug users. Retrospective.
- Drug Recovery (In Vitro): Oral fluid spiked with drugs at specific concentrations. Number of samples not explicitly stated but implied to be sufficient for LC-MS/MS or GC-MS testing. This is an in-vitro study.
- Oral Fluid Sample Extraction Efficiency and Stability: Oral fluid spiked with drugs. Number of samples not explicitly stated. This is an in-vitro study.
- Sample Transportation Stability: Oral fluid spiked with drugs. Number of replicates not explicitly stated for each condition, but tested in "replicates of two" within the variable temperature range. This is an in-vitro study with simulated transport conditions.
- Borosilicate Glass Vial Stability: Oral fluid spiked with drugs, initial concentration analyzed, then tested with three vials sequentially. This is an in-vitro study.
- Clinical Specimens:
- Drug-Free: 40 deidentified, unaltered clinical oral fluid samples collected by expectoration and Quantisal II for each drug class/analyte. (Total 40 drug-free per drug x 15 drugs = 600 samples for the device, and 600 for expectoration).
- Containing Drug: 40 deidentified, unaltered clinical oral fluid samples (except for Hydrocodone with 18 samples) obtained from clinical research facility, collected by expectoration and Quantisal II for each drug class/analyte. (Total ~578 samples for the device, and ~578 for expectoration).
- Provenance: Clinical research facility, "deidentified, unaltered" samples. Country of origin not explicitly stated but implied to be within the US given FDA submission. Retrospective (samples "obtained").
- Expectorated Oral Fluid Samples Processed Through Quantisal II (Dipping Study): At least 60 deidentified, unaltered drug-containing oral fluid samples collected by expectoration from a clinical research facility. A minimum of 10 samples for each drug were within ±50% of the confirmation cutoffs. Total of 900 paired results were analyzed (Implied: 60 samples x 15 drugs = 900 measurements, or 60 samples for an undisclosed mix of drugs). Retrospective (samples "collected").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a device for collecting samples for chemical analysis, not an AI/ML diagnostic interpretation. The "ground truth" for the drug concentrations was established through quantitative laboratory methods (LC-MS/MS or GC-MS), which are considered objective analytical techniques rather than expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Ground truth was established by laboratory instrumentation (LC-MS/MS or GC-MS), not human 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
Not applicable. This is not an AI/ML diagnostic device that involves human readers or interpretation of medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a collection device, not an algorithm. The reported performance is the device's ability to collect, preserve, and transport samples for subsequent laboratory analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the presence and concentration of drugs in oral fluid samples was established using quantitative analytical methods: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GC-MS). These are highly sensitive and specific laboratory techniques considered gold standards for drug detection and quantification in biological matrices. For the clinical specimens, the "clinical truth" was defined by the expectorated neat oral fluid sample analyzed by LC-MS/MS or GC-MS.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set." The studies were designed to validate the physical and chemical performance of the collection device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.