(123 days)
Not Found
No
The device description and performance studies focus on the physical collection and preservation of oral fluid samples, with analysis performed using standard laboratory techniques (LC-MS/MS or GC-MS). There is no mention of AI or ML in the device's function or the analysis of the collected data.
No
The device is described as an "In Vitro Diagnostic Use" device, designed for the "collection, preservation and transport of oral fluid specimens" to detect various substances, rather than for treating a disease or condition.
No
The device is a collection, preservation, and transport system for oral fluid specimens, not a diagnostic device itself. The extracted oral fluid specimens are intended for in vitro diagnostic use, meaning they will be analyzed by other diagnostic methods.
No
The device description clearly outlines a physical collection device consisting of a cellulose pad, polypropylene stem, and polypropylene tube with preservative buffer. The performance studies also focus on the physical characteristics and performance of this hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For In Vitro Diagnostic Use" in the "Intended Use / Indications for Use" section.
- Intended Use: The intended use is for the "collection, preservation and transport of oral fluid specimens for [a list of specific drugs and metabolites]". This indicates the device is used to prepare a biological sample for subsequent diagnostic testing outside of the body (in vitro).
- Device Description: The description details how the device collects and preserves an oral fluid specimen for analysis.
- Performance Studies: The performance studies focus on aspects relevant to the diagnostic process, such as sample volume, drug recovery, stability, and comparison to other collection methods, all of which are crucial for ensuring the reliability of subsequent diagnostic tests.
The device is designed to collect and prepare a sample that will be analyzed in vitro to diagnose or detect the presence of specific substances. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
PJD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral fluid specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- Sample Volume: Seventy-five oral fluid samples from known drug users were collected using Quantisal collectors. The results confirmed consistency of sample volume of 1 mL collected by the Quantisal collector.
- Sample Collection Time: Seventy-five oral fluid samples from known drug users were collected using Quantisal collector. 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.
- Drug Recovery: Drug free negative oral fluid spiked with specific drugs at ±25%, +50% of the cutoff were collected and stored in Quantisal Oral Fluid Collection Device overnight at room temperature. LC-MS/MS or GC-MS testing was performed to determine percentage recovery. The studies demonstrated the Quantisal Collection Device recovers tested drugs at greater than 80% of the original concentration.
- Oral Fluid Sample Extraction Efficiency and Stability: Drug free negative oral fluid spiked with drugs at +50% of the cutoff were collected and stored in Quantisal Oral Fluid Collection Device and tested by LC-MS/MS or GC/MS at each time point at 25°C during the first 24 hours post-collection. The drug recovery 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. Sample Stability testing was performed using LC-MS/MS or GC/MS at multiple timepoints post-collection at 25°C and at 2°C - 8°C.
- Sample Transportation Stability: Drug free negative oral fluid spiked with drugs at ±50% of the cutoff were collected and stored in Quantisal Oral Fluid Collection Device and packed in standard boxes used by common carrier. During a 4-day (96 hours) simulated transportation study, samples were stored in oven/freezer at temperatures ranged from -20°C. Additionally, a supplemental study tested samples stored at 25°C, 40°C and 2°C-8°C for 24 hours. The studies demonstrated the drug concentration of the sample collected by Quantisal Oral Fluid Collection Device is within 20% of reference value during transportation.
- Borosilicate Glass Vial Stability: Drug free expectorated oral fluid was spiked with the drug analyte at a concentration +50% of the confirmation cutoffs. Three borosilicate glass vials were introduced sequentially into each aliquot, stored at 25℃ for 48 hours, and then tested using mass spectrometry. 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.
- Expectorated Oral Fluid Samples Processed Through Quantisal (Dipping Study): At least sixty deidentified, unaltered drug containing oral fluid samples were collected by expectoration and analyzed using LC-MS/MS or GC/MS. A Quantisal device was introduced into each expectorated sample and analyzed the next day. 899/900 paired results meet the criteria that Quantisal concentration was within ±20% of the expectorated result. This study demonstrated no difference in drug concentrations in oral fluid when expectorated samples are compared to the same oral fluid subjected to Quantisal collection regardless of drug class.
- Drug Free Clinical Specimens: At least forty deidentified, unaltered drug free clinical oral fluid samples collected by expectoration and Quantisal Oral Fluid Collection Devices were obtained from clinical research facility, analyzed for drugs using LC-MS/MS or GC/MS. The results of all expectorated samples and Quantisal samples are negative for each drug. The study demonstrated the accuracy of the Quantisal Oral Fluid Collection Device when collecting drug free clinical specimens.
Key Metrics
Recovery: >80% of original concentration for tested drugs.
Sample Collection Time: within 10 minutes in over 90% of subjects.
Extraction Efficiency: >80% at 4 hours post collection, >90% at 24 hours (complete extraction).
Transportation Stability: drug concentration within 20% of reference value.
Borosilicate Glass Vial Stability: drug loss within ±10% of initial value.
Expectorated Oral Fluid Samples Processed Through Quantisal: 899/900 paired results within ±20% of the expectorated result.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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July 28, 2020
Immunalysis Corporation Wenying (Jessica) Zhu Manager, Regulatory Affairs 829 Towne Center Drive Pomona, CA 91767
Re: K200801
Trade/Device Name: Quantisal™ Oral Fluid Collection Device Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: PJD Dated: June 26, 2020 Received: June 30, 2020
Dear Wenying (Jessica) Zhu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, M.T., Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200801
Device Name Quantisal™ Oral Fluid Collection Device
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable) | |
---|---|
❌ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
A. GENERAL INFORMATION
| Applicant Name: | Immunalysis Corporation
829 Towne Center Drive
Pomona, CA 91767
Establishment # 2020952 |
|------------------|--------------------------------------------------------------------------------------------------------------|
| Company Contact: | Wenying (Jessica) Zhu
Manager, Regulatory Affairs
Phone: (909) 451-6697
Email: wzhu@immunalysis.com |
| Date Prepared: | July 23, 2020 |
B. DEVICE IDENTIFICATION
Trade or Proprietary Names: | Quantisal™ Oral Fluid Collection Device |
---|---|
Common Name: | Oral Fluid Collection Device |
C. REGULATORY INFORMATION
| Device Classification Name: | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen
Collection Device |
|-----------------------------|--------------------------------------------------------------------------|
| Product Codes: | PJD |
| Regulatory Class: | Class II |
| Classification Regulation: | 862.1675 |
| Panel: | Clinical Chemistry (75) |
| Predicate Device: | Quantisal™ II Oral Fluid Collection Device [K183048] |
D. DEVICE DESCRIPTION
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.
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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.
E. INTENDED USE
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, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines and tramadol.
| Attribute | Predicate Device
Quantisal II Oral Fluid Collection
Device [K183048] | Candidate Device
Quantisal Oral Fluid Collection
Device | | |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--|--|
| Similarities | | | | |
| Intended Use | Collection, preservation and transport
of oral fluid specimens for
tetrahydrocannabinol (THC), cocaine
and its metabolite benzoylecgonine,
morphine, codeine, oxycodone,
hydrocodone, 6-acetylmorphine,
phencyclidine, amphetamine,
methamphetamine, buprenorphine,
methadone, benzodiazepines and
tramadol. For prescription Use only. | Identical | | |
| Material | Cellulose pad, polypropylene stem and
transport tube | Identical | | |
| Body Contact | Cellulose pad placed under the tongue
for up to 10 mins | Identical | | |
| Principle | Collecting an oral fluid specimen on a
cellulose pad and preserving it in a
buffer solution contained in a
collection tube | Identical | | |
| Sample Collection | Place cellulose pad under the tongue
for collection until blue dye visible in
the window of the stem | Identical | | |
| Transport Tube | Polypropylene tube containing
preservative buffer | Identical | | |
| Sample Matrix | Human oral fluid | Identical | | |
| Differences | | | | |
| Collector | Collector containing two pads. These
two pads can be separated after
collection | Collector containing one pad | | |
| Sample Volume | 1 mL on each pad, 2 mL in total | 1 mL | | |
F. COMPARISON WITH PREDICATE
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| Attribute | Predicate Device
Quantisal II Oral Fluid Collection
Device [K183048] | Candidate Device
Quantisal Oral Fluid Collection
Device |
|---------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------|
| Qty. of Transport
Tube | 2 transport tubes, 1 for each pad | 1 transport tube |
G. PERFORMANCE CHARACTERISTICS
The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Quantisal Oral Fluid Collection Devices to the predicate device. Clinical and analytical performances were established using Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and Gas chromatography-mass spectrometry (GC-MS).
1. Sample Volume
Seventy-five oral fluid samples from known drug users were collected using Quantisal collectors (collection pad with plastic stem). After the volume adequacy indicator turned blue on the collector stem, the collector was weighed and compared to the average weight of collector before collection. The difference in weight was noted. Specific gravity of saliva was rounded to 1.000 to compute the volume collection. The results confirmed consistency of sample volume of 1 mL collected by the Ouantisal collector.
2. Sample Collection Time
Seventy-five oral fluid samples from known drug users were collected using Quantisal collector (collection pad with plastic stem). The collection time was documented. 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
Drug free negative oral fluid spiked with the drug listed in Table 1 at ±25%, +50% of the cutoff were collected and stored in Quantisal Oral Fluid Collection Device overnight at room temperature. LC-MS/MS or GC-MS testing was performed the next day to determine percentage recovery. The studies demonstrated the Quantisal Collection Device recovers tested drugs at greater than 80% of the original concentration.
| Drugs | Testing
Method | SAMHSA Screening
Cutoff (ng/mL) |
|-----------------|-------------------|------------------------------------|
| THC | GC-MS | 4 |
| Benzoylecgonine | LC-MS/MS | 15 |
| Cocaine | LC-MS/MS | 15 |
| Morphine | LC-MS/MS | 30 |
| Codeine | LC-MS/MS | 30 |
| Oxycodone | LC-MS/MS | 30 |
Table 1. Drug Information
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| Drugs | Testing
Method | SAMHSA Screening
Cutoff (ng/mL) |
|-------------------|-------------------|------------------------------------|
| Hydrocodone | LC-MS/MS | 30 |
| 6-acetylmorphine | LC-MS/MS | 4 |
| Phencyclidine | LC-MS/MS | 10 |
| Amphetamine | LC-MS/MS | 50 |
| Methamphetamine | LC-MS/MS | 50 |
| Buprenorphine* | LC-MS/MS | 3 |
| Methadone* | LC-MS/MS | 20 |
| Benzodiazepines * | LC-MS/MS | 5 |
| Tramadol* | GC-MS | 50 |
*Cutoff not established by SAMHSA. Buprenorphine cutoff is suggested by Brigham and Women's Hospital, Boston, MA. Methadone cutoff is determined by the reference article (1). Benzodiazepines and Tramadol cutoffs are determined by referencing 2013-2014 National Roadside Study of Alcohol and Drug Use by Drivers.
4. Oral Fluid Sample Extraction Efficiency and Stability
Drug free negative oral fluid spiked with drugs listed in Table 1 at +50% of the cutoff were collected and stored in Quantisal Oral Fluid Collection Device and tested by LC-MS/MS or GC/MS at each time point at 25°C during the first 24 hours post-collection to determine the point at which extraction was complete and used as a baseline for comparison for determining sample stability. The drug recovery 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.
Sample Stability testing was performed using LC-MS/MS or GC/MS at multiple timepoints postcollection at 25°C and at 2°C - 8°C. The results are presented in Table 2.
Drugs | Stability at 8-25°C | Stability at 2-8°C |
---|---|---|
THC | 10 days | 2 months |
Benzoylecgonine | 10 days | 3 months |
Cocaine | 5 days | 1 month |
Morphine | 10 days | 3 months |
Codeine | 10 days | 3 months |
Oxycodone | 10 days | 3 months |
Hydrocodone | 10 days | 3 months |
6-acetylmorphine | 10 days | 3 months |
Phencyclidine | 10 days | 3 months |
Amphetamine | 10 days | 3 months |
Methamphetamine | 10 days | 3 months |
Buprenorphine | 10 days | 3 months |
Methadone | 10 days | 3 months |
Table 2. Oral Fluid Sample Stability Results
1 Teresa R. Gray, Riet Dams, Robin E. Choo, Hendree E. Jones, Marilyn A. Huestis, Methadone disposition in oral fluid during pharmacotherapy for opioid-dependence, Forensic Science International 206 (2011)98-102.
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Drugs | Stability at 8-25°C | Stability at 2-8°C |
---|---|---|
Benzodiazepines | 10 days | 3 months |
Tramadol | 10 days | 3 months |
5. Sample Transportation Stability
Drug free negative oral fluid spiked with drugs listed in Table 1 at ±50% of the cutoff were collected and stored in Ouantisal Oral Fluid Collection Device and packed in standard boxes used by common carrier (FedEx). During the 4-day (96 hours) simulated transportation study, the samples were stored in oven/freezer at temperatures ranged from -20°C to encompass the temperatures likely to occur during shipment of products. The device used as the reference (unstressed) condition was stored continuously at the recommended storage condition at 2°C -8°C. LC-MS/MS or GC/MS testing was performed in replicates of two and compared to the reference sample. Additionally, a supplemental study was performed by testing samples collected by Quantisal device stored at three different temperature ranges for 24 hours respectively: 25°C, 40°C and 2°C-8°C. The studies demonstrated the drug concentration of the sample collected by Quantisal Oral Fluid Collection Device is within 20% of reference value during transportation.
6. Borosilicate Glass Vial Stability
Drug free expectorated oral fluid was spiked with the drug analyte at a concentration +50% of the confirmation cutoffs listed in Table 3. The initial concentration of the solution was analyzed by mass spectrometry. Three borosilicate glass vials were introduced sequentially into each aliquot, stored at 25℃ for 48 hours, and then tested using the same analytical method. 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.
| Drugs | Testing
Method | SAMHSA Confirmation Cutoff
(ng/mL) |
|------------------|-------------------|--------------------------------------------------------------------------|
| THC | GC-MS | 2 |
| Benzoylecgonine | LC-MS/MS | 8 |
| Cocaine | LC-MS/MS | 8 |
| Morphine | LC-MS/MS | 15 |
| Codeine | LC-MS/MS | 15 |
| Oxycodone | LC-MS/MS | 15 |
| Hydrocodone | LC-MS/MS | 15 |
| 6-acetylmorphine | LC-MS/MS | 2 |
| Phencyclidine | LC-MS/MS | 10 (laboratory LOQ 5 ng/mL was used) |
| Amphetamine | LC-MS/MS | 25 (15 ng/mL was used according to
previously proposed SAMHSA cutoff) |
| Methamphetamine | LC-MS/MS | 25 (15 ng/mL was used according to
previously proposed SAMHSA cutoff) |
| Buprenorphine* | LC-MS/MS | 3 |
Table 3. Drug Information
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| Drugs | Testing
Method | SAMHSA Confirmation Cutoff
(ng/mL) |
|------------------|-------------------|---------------------------------------|
| Methadone* | LC-MS/MS | 20 |
| Benzodiazepines* | LC-MS/MS | 5 |
| Tramadol* | GC-MS | 50 |
*Cutoff not established by SAMHSA.
7. Expectorated Oral Fluid Samples Processed Through Quantisal (Dipping Study)
At least sixty deidentified, unaltered drug containing oral fluid samples were collected by expectoration (spitting) at clinical research facility, and analyzed using LC-MS/MS or GC/MS. A minimum of ten samples of each drug were within ±50% of the confirmation cutoffs listed in Table 3. A Quantisal device was introduced into each expectorated sample. The next day, Quantisal samples were analyzed by mass spectrometry. 899/900 paired results meet the criteria that Quantisal concentration was within ±20% of the expectorated result. This study demonstrated no difference in drug concentrations in oral fluid when expectorated samples are compared to the same oral fluid subjected to Quantisal collection regardless of drug class. The Quantisal oral fluid collection device does not introduce bias to quantitative results of expectoration neat oral fluid sample (clinical truth).
8. Drug Free Clinical Specimens
At least forty deidentified, unaltered drug free clinical oral fluid samples collected by expectoration (spitting) and Quantisal Oral Fluid Collection Devices were obtained from clinical research facility, analyzed for drug listed in Table 3 using LC-MS/MS or GC/MS. The results of all expectorated samples and Quantisal samples are negative for each drug. The study demonstrated the accuracy of the Quantisal Oral Fluid Collection Device when collecting drug free clinical specimens.
H. CONCLUSION
The information provided in this premarket notification demonstrates that the Immunalysis Quantisal Oral Fluid Collection Device is substantially equivalent to the legally marketed predicate device.