(123 days)
For In Vitro Diagnostic Use
The Quantisal Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), cocaine and its metabolite benzoylecgonine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, buprenorphine, methadone, benzodiazepines and tramadol.
The Quantisal Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), cocaine and its metabolite benzoylecgonine, morphine, codeine, oxycodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines and tramadol. This device is for prescription use only.
An oral fluid specimen is collected by placing a cellulose pad affixed to a polypropylene stem (Collector) 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 transferred into a provided polypropylene tube containing a specific volume of preservative buffer. The tube is stoppered with provided caps. The specimen is ready for storage or transport.
The Quantisal 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 Oral Fluid Collection Device is sold as a stand-alone collection device.
Here's a breakdown of the acceptance criteria and study information for the Quantisal™ Oral Fluid Collection Device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Sample Volume Consistency | The implicit criterion is that the collected sample volume should be consistent at 1 mL, as indicated by the blue coloration in the collector stem's window. | The results confirmed consistency of sample volume of 1 mL collected by the Quantisal collector. |
| 2. Sample Collection Time | The implicit criterion is that the collection time should be within the claimed time of 10 minutes for a high percentage of subjects. | The results verified the sample collection time for Quantisal Oral Fluid Collection Device is within the claimed time of 10 minutes in over 90% of subjects. |
| 3. Drug Recovery | Greater than 80% recovery of the original drug concentration after overnight storage at room temperature. (This is inferred from the statement that the studies demonstrated recovery greater than 80%). The document does not explicitly state this as an acceptance criterion but as a demonstrated outcome. | Recovered tested drugs at greater than 80% of the original concentration for all drugs listed (THC, Benzoylecgonine, Cocaine, Morphine, Codeine, Oxycodone, Hydrocodone, 6-acetylmorphine, Phencyclidine, Amphetamine, Methamphetamine, Buprenorphine, Methadone, Benzodiazepines, Tramadol). |
| 4. Oral Fluid Sample Extraction Efficiency | Minimum acceptance criterion of >80% drug recovery at 4 hours post-collection, and >90% at 24 hours for complete extraction. | Met the minimum acceptance criterion of >80% at 4 hours post-collection for all drugs and reached >90% at 24 hours for all drugs to show a complete extraction. |
| 4. Oral Fluid Sample Stability | Data is presented in Table 2, showing stability for specified durations at different temperatures (8-25°C and 2-8°C). The implicit criterion is that drugs remain stable for these durations. Specific quantitative criteria are not stated for stability (e.g., within X% of initial concentration), but the results presented indicate meeting these stability claims. | Stability at 8-25°C: 5 to 10 days depending on the drug. Stability at 2-8°C: 1 to 3 months depending on the drug. (See Table 2 for full details). |
| 5. Sample Transportation Stability | Drug concentration of the sample collected by Quantisal Oral Fluid Collection Device is within 20% of the reference value during transportation. | Demonstrated the drug concentration of the sample collected by Quantisal Oral Fluid Collection Device is within 20% of the reference value during transportation for a 4-day (96 hours) simulated study and a 24-hour supplemental study at various temperatures. |
| 6. Borosilicate Glass Vial Stability | Drug loss of the samples collected by borosilicate glass vial was within ±10% of the initial value after 48 hours storage at 25°C. | The drug loss of the samples collected by borosilicate glass vial was within ±10% of the initial value after 48 hours storage at 25°C. |
| 7. Expectorated Oral Fluid Samples Processed Through Quantisal (Dipping Study) | Quantisal concentration was within ±20% of the expectorated result. | 899/900 paired results met the criteria that Quantisal concentration was within ±20% of the expectorated result. The study demonstrated no difference in drug concentrations. |
| 8. Drug-Free Clinical Specimens Accuracy | The results of all expectorated samples and Quantisal samples are negative for each drug. (Implicitly, 100% accuracy for drug-free samples). | All expectorated samples and Quantisal samples were negative for each drug. The study demonstrated the accuracy of the Quantisal Oral Fluid Collection Device when collecting drug-free clinical specimens. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Volume Consistency: 75 oral fluid samples from known drug users. Data provenance is not specified beyond "known drug users." This sounds like prospective collection for the study.
- Sample Collection Time: 75 oral fluid samples from known drug users. Data provenance is not specified beyond "known drug users." This sounds like prospective collection for the study.
- Drug Recovery: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples, not human subjects.
- Oral Fluid Sample Extraction Efficiency and Stability: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
- Sample Transportation Stability: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
- Borosilicate Glass Vial Stability: Drug-free expectorated oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
- Expectorated Oral Fluid Samples Processed Through Quantisal (Dipping Study): At least 60 de-identified, unaltered drug-containing oral fluid samples. Provenance is "collected by expectoration (spitting) at clinical research facility." This indicates prospective collection of clinical samples.
- Drug Free Clinical Specimens: At least 40 de-identified, unaltered drug-free clinical oral fluid samples. Provenance is "obtained from clinical research facility." This indicates prospective collection of clinical samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- No specific information is provided regarding the number or qualifications of experts for establishing ground truth.
- For spiked samples, the "ground truth" is the known concentration of the spiked drugs, as determined by laboratory methods.
- For clinical samples (Dipping Study and Drug-Free Clinical Specimens), the ground truth was established by LC-MS/MS or GC-MS analysis of the expectorated (neat) oral fluid samples, which are high-accuracy analytical methods typically used in forensic or clinical toxicology laboratories. This is considered an analytical ground truth rather than an expert consensus based on visual assessment or interpretation.
4. Adjudication Method for the Test Set
- Not applicable as this is a device for specimen collection and preservation, with performance evaluated by objective analytical methods (LC-MS/MS, GC-MS) rather than subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation devices where human readers are involved in making decisions, and the AI's impact on human performance is assessed. This device is a collection tool, not an interpretive one.
6. Standalone (Algorithm Only) Performance
- This device is not an algorithm or AI in the traditional sense. It's a physical collection device. Its "standalone" performance refers to its ability to collect, preserve, and transport samples effectively, and this was evaluated by the various laboratory performance studies (e.g., drug recovery, stability, comparison to expectorated samples). The analytical tests (LC-MS/MS, GC-MS) were performed on the collected samples to determine the device's performance.
7. The Type of Ground Truth Used
- Analytical Ground Truth:
- For spiked samples and stability studies: The known concentration of drugs in the prepared solutions.
- For clinical samples (Dipping Study and Drug Free Clinical Specimens): The drug concentrations (or absence of drugs) as determined by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GC-MS) of the neat/expectorated oral fluid. These are highly accurate, gold-standard analytical methods for drug quantification and identification.
8. The Sample Size for the Training Set
- This device does not involve a "training set" in the context of machine learning or algorithms. It is a physical device, and its performance is evaluated through a series of analytical and clinical studies as described.
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.