(269 days)
No
The device is a physical collection and preservation system for oral fluid samples. The description focuses on the mechanical aspects of collection, volume adequacy indication, and sample storage/transport. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies evaluate the physical collection process and sample stability, not the performance of an analytical or interpretive algorithm.
No
The device is described as an oral fluid collection device intended for the collection, preservation, and transport of oral fluid specimens for drug testing. It is clearly a diagnostic tool, not a therapeutic one.
No
The device is described as an oral fluid collection device intended for the collection, preservation, and transport of oral fluid specimens for drug analysis. It does not perform the diagnostic analysis itself; rather, it prepares and preserves the sample for subsequent laboratory testing.
No
The device description clearly outlines physical components (cellulose pads, polypropylene stem, polypropylene tubes, caps) and a physical mechanism for collection and preservation of oral fluid. It is a hardware device for specimen collection.
Based on the provided information, the Quantisal II Oral Fluid Collection Device is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "collection, preservation and transport of oral fluid specimens for [a list of specific drug analytes]". This indicates that the collected specimen is intended for subsequent testing in vitro (outside the body) to diagnose or detect the presence of these substances.
- Device Description: The description details how the oral fluid is collected and preserved in a buffer solution within tubes, ready for "storage or transport" and subsequent "screening and confirmation testing". This further supports the use of the collected specimen for laboratory analysis.
- Performance Studies: The performance studies focus on aspects crucial for an IVD device used for specimen collection for drug testing, such as:
- Sample Volume consistency
- Drug Recovery from the collection device
- Oral Fluid Sample Extraction Efficiency and Stability
- Sample Transportation Stability
- Comparison of results from the device to expectorated samples and between the two collection pads.
These studies are designed to demonstrate the suitability of the device for collecting a specimen that will be used in a diagnostic test.
- Predicate Device: The mention of a predicate device (K942435; Saliva Sampler) which is also likely an IVD device for oral fluid collection, further supports the classification of the Quantisal II as an IVD.
While the document doesn't explicitly state "In Vitro Diagnostic Device" in the intended use, the function of collecting and preserving a biological specimen for subsequent laboratory testing to detect specific analytes falls squarely under the definition of an IVD device. The device itself is not performing the diagnostic test, but it is an essential component in the process of obtaining a specimen for an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
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, b-acetylmorphine, phencyclidine, amphetamine, buprenorphine, methadone, benzodiazepines and tramadol. This device is for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
PJD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
under the tongue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Clinical Specimens:
At least forty deidentified, unaltered drug free clinical oral fluid samples and forty deidentified, unaltered clinical oral fluid samples containing drug for each drug class collected by expectoration (spitting) and Quantisal II Oral Fluid Collection Devices were obtained from clinical research facility, analyzed for drug listed in Table 3 using LC-MS/MS or GC/MS. Quantisal II "A" and "B" results were compared to each other. The expectoration and Quantisal II results were compared against confirmation cutoffs listed in Table 3.
Expectorated Oral Fluid Samples Processed Through Quantisal II (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 II device was introduced into each expectorated sample. The next day, Quantisal II samples A and B were analyzed by mass spectrometry.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Sample Volume:
Fifty oral fluid samples were collected using Quantisal II collectors (collection pad with plastic stem) from fifty volunteers. Prior to collection, each collector (A and B) was weighed. After the volume adequacy indicator turned blue on both A and B collector stems, each collector was weighed again. 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 each of Quantisal II collectors, and the volume difference between collector A and B doesn't exceed 15%.
Additional seventy-five oral fluid samples from known drug users were collected using Quantisal II collector. After the volume adequacy indicator turned blue on both A and B collector stems, each 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.
2. Sample Collection Time:
Fifty oral fluid samples from volunteers and seventy-five oral fluid samples from known drug users were collected using Quantisal II collection pad with plastic stem). The collection time was documented. The results verified the sample collection time for Quantisal II Oral Fluid Collection Device is within the claimed time of 10 minutes in over 99% of subjects.
3. Drug Recovery:
Drug free negative oral fluid spiked with the drug listed in Table 1 at ±25%, +50% of the concentrations also listed in the table were collected and stored in Quantisal II 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 II Collection Device recovers tested drugs at greater than 80% of the original concentration.
4. Oral Fluid Sample Extraction Efficiency and Stability:
Drug free negative oral fluid spiked with drugs listed in Table 1 at +50% of the concentration listed in the table were collected and stored in Quantisal II 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 postcollection to determine the point at which extraction was complete and used as a baseline for comparison for determining sample stability. The drug recovery was >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℃ and at 2℃ - 8℃. The results are presented in Table 2. The refrigerated study is still ongoing.
Additional stability testing was performed on Quantisal II B specimens to verify oral fluid samples containing tested drugs stored in Quantisal II are stable after refrigerated storage. Stability results indicated that the Quantisal II "B" specimen retained for a "split specimen re-confirmation test" were within 100+/- 10% recovery 1 months storage at 2°C - 8°C.
5. Sample Transportation Stability:
Drug free negative oral fluid spiked with drugs listed in Table 1 at ±50% of the concentration listed in the table were collected and stored in Quantisal II 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℃ to 40℃ 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℃ - 8℃. LC-MS/MS or GC/MS testing was performed in replicates of two and compared to the reference sample. The studies demonstrated the drug concentration of the sample collected by Quantisal II 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 concentrations 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.
7. Clinical Specimens:
At least forty deidentified, unaltered drug free clinical oral fluid samples and forty deidentified, unaltered clinical oral fluid samples containing drug for each drug class collected by expectoration (spitting) and Quantisal II Oral Fluid Collection Devices were obtained from clinical research facility, analyzed for drug listed in Table 3 using LC-MS/MS or GC/MS. Quantisal II "A" and "B" results were compared to each other. The expectoration and Quantisal II results were compared against confirmation cutoffs listed in Table 3. A summary of the test results is presented in Table 4. The study demonstrated the accuracy between the two collectors of the Quantisal II Oral Fluid Collection Device when collecting clinical specimens. In no case was the expectorated neat oral fluid positive and the Quantisal II collected samples negative or vice versa. If drugs were present, they were present in samples from both oral fluid expectoration and device collection methods.
8. Expectorated Oral Fluid Samples Processed Through Quantisal II (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 II device was introduced into each expectorated sample. The next day, Quantisal II samples A and B were analyzed by mass spectrometry. 899/900 paired results meet the criteria that Quantisal II A and B concentrations were within 15% of each other. 899/900 paired results meet the criteria that Quantisal II concentration was within ±20% of the expectoration 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 II collection regardless of drug class. The Quantisal II oral fluid collection device does not introduce bias to quantitative and qualitative results of expectoration neat oral fluid sample (clinical truth).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Saliva Sampler [K942435]
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 29, 2019
Immunalysis Corporation Wenving (Jessica) Zhu Senior Regulatory Affairs Specialist 829 Towne Center Drive Pomona, CA 91767
Re: K183048
Trade/Device Name: Quantisal II 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 17, 2019 Received: June 18, 2019
Dear Wenying (Jessica) Zhu:
We have reviewed vour 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
1
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 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 medical devices and radiation-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,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183048
Device Name
Immunalysis Quantisal™ II Oral Fluid Collection Device
Indications for Use (Describe)
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.
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 24, 2019 |
B. DEVICE IDENTIFICATION
Trade or Proprietary Names: | Immunalysis Quantisal™ II 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: | Saliva Sampler [K942435] |
D. DEVICE DESCRIPTION
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
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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.
E. INTENDED USE
The Quantisal II Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), benzoylecgonine, cocaine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines and tramadol. This device is for prescription use only.
| Attribute | Predicate Device
Saliva Sampler [K942435] | Candidate Device
Immunalysis Quantisal II Oral Fluid
Collection Device |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Collection and transport of oral fluid
specimens for drug testing | Collection, preservation and transport
of oral fluid specimens for drug testing |
| Material | Cellulose pad, polypropylene stem and
transport tube | Same |
| Body Contact | Cellulose pad placed under the tongue
for up to 10 mins | Same |
| Principle | Collecting an oral fluid specimen on a
cellulose pad and preserving it in a
buffer solution contained in a
collection tube | Same |
| Sample Collection | Place cellulose pad under the tongue
for collection until blue dye visible in
the window of the stem | Same |
| Transport Tube | Polypropylene tube containing
preservative buffer | Same |
| Sample Matrix | Human oral fluid | Same |
| Differences | | |
| Collector | Collector containing one pad | Collector containing two pads. These
two pads can be separated after
collection |
| Sample Volume | 1 mL | 1 mL on each pad, 2 mL in total |
| Qty. of Transport
Tube | 1 transport tube | 2 transport tubes, 1 for each pad |
F. COMPARISON WITH PREDICATE
G. PERFORMANCE CHARACTERISTICS
The following laboratory performance studies were performed to determine substantial
5
equivalence of the Immunalysis Quantisal II Oral Fluid Collection Devices to the predicate device. Clinical and analytical performances were established using Liquid chromatographytandem mass spectrometry (LC-MS/MS) and Gas chromatography-mass spectrometry (CC-MS).
1. Sample Volume
Fifty oral fluid samples were collected using Quantisal II collectors (collection pad with plastic stem) from fifty volunteers. Prior to collection, each collector (A and B) was weighed. After the volume adequacy indicator turned blue on both A and B collector stems, each collector was weighed again. 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 each of Quantisal II collectors, and the volume difference between collector A and B doesn't exceed 15%.
Additional seventy-five oral fluid samples from known drug users were collected using Quantisal II collector. After the volume adequacy indicator turned blue on both A and B collector stems, each 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.
2. Sample Collection Time
Fifty oral fluid samples from volunteers and seventy-five oral fluid samples from known drug users were collected using Quantisal II collection pad with plastic stem). The collection time was documented. The results verified the sample collection time for Quantisal II Oral Fluid Collection Device is within the claimed time of 10 minutes in over 99% of subjects.
3. Drug Recovery
Drug free negative oral fluid spiked with the drug listed in Table 1 at ±25%, +50% of the concentrations also listed in the table were collected and stored in Quantisal II 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 II Collection Device recovers tested drugs at greater than 80% of the original concentration.
| Drugs | Testing
Method | Concentration
(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 |
| Hydrocodone | LC-MS/MS | 30 |
| 6-acetylmorphine | LC-MS/MS | 4 |
| Phencyclidine | LC-MS/MS | 10 |
Table 1. Drug Information
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| Drugs | Testing
Method | Concentration
(ng/mL) |
|-----------------|-------------------|--------------------------|
| Amphetamine | LC-MS/MS | 50 |
| Methamphetamine | LC-MS/MS | 50 |
| Buprenorphine* | LC-MS/MS | 3 |
| Methadone* | LC-MS/MS | 20 |
| Nordiazepam* | LC-MS/MS | 5 |
| Tramadol* | GC-MS | 50 |
4. Oral Fluid Sample Extraction Efficiency and Stability
Drug free negative oral fluid spiked with drugs listed in Table 1 at +50% of the concentration listed in the table were collected and stored in Quantisal II 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 postcollection to determine the point at which extraction was complete and used as a baseline for comparison for determining sample stability. The drug recovery was >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℃ and at 2℃ - 8℃. The results are presented in Table 2. The refrigerated study is still ongoing.
Drugs | Stability at 8-25°C | Stability at 2-8°C |
---|---|---|
THC | 10 days | 10 days |
Benzoylecgonine | 10 days | 10 days |
Cocaine | 5 days | 10 days |
Morphine | 10 days | 10 days |
Codeine | 10 days | 10 days |
Oxycodone | 10 days | 10 days |
Hydrocodone | 10 days | 10 days |
6-acetylmorphine | 10 days | 10 days |
Phencyclidine | 10 days | 10 days |
Amphetamine | 10 days | 10 days |
Methamphetamine | 10 days | 10 days |
Buprenorphine | 10 days | 10 days |
Methadone | 10 days | 10 days |
Benzodiazepines | 10 days | 10 days |
Tramadol | 10 days | 10 days |
Table 2. Oral Fluid Sample Stability Results
Additional stability testing was performed on Quantisal II B specimens to verify oral fluid samples containing tested drugs stored in Quantisal II are stable after refrigerated storage. Stability results indicated that the Quantisal II "B" specimen retained for a "split specimen re-
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confirmation test" were within 100+/- 10% recovery 1 months storage at 2°C - 8°C.
| Drugs | Testing
Method | Concentration
(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 | 2 |
| Amphetamine | LC-MS/MS | 15 |
| Methamphetamine | LC-MS/MS | 15 |
| Buprenorphine* | LC-MS/MS | 3 |
| Methadone* | LC-MS/MS | 20 |
| Benzodiazepines* | LC-MS/MS | 5 |
| Tramadol* | GC-MS | 50 |
Table 3. Drug Information
5. Sample Transportation Stability
Drug free negative oral fluid spiked with drugs listed in Table 1 at ±50% of the concentration listed in the table were collected and stored in Quantisal II 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℃ to 40℃ 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℃ - 8℃. LC-MS/MS or GC/MS testing was performed in replicates of two and compared to the reference sample. The studies demonstrated the drug concentration of the sample collected by Quantisal II 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 concentrations 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.
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7. Clinical Specimens
At least forty deidentified, unaltered drug free clinical oral fluid samples and forty deidentified, unaltered clinical oral fluid samples containing drug for each drug class collected by expectoration (spitting) and Quantisal II Oral Fluid Collection Devices were obtained from clinical research facility, analyzed for drug listed in Table 3 using LC-MS/MS or GC/MS. Quantisal II "A" and "B" results were compared to each other. The expectoration and Quantisal II results were compared against confirmation cutoffs listed in Table 3. A summary of the test results is presented in Table 4. The study demonstrated the accuracy between the two collectors of the Quantisal II Oral Fluid Collection Device when collecting clinical specimens. In no case was the expectorated neat oral fluid positive and the Quantisal II collected samples negative or vice versa. If drugs were present, they were present in samples from both oral fluid expectoration and device collection methods.
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Table 4. Summary of Clinical Specimens Test Results
| Drug Class | Drug | Sample Type | Number of Samples
for Each Drug | Quantisal II A and B
samples within ±15% of
each other | Quantisal II A/B
Agreement with
Expectorated Samples |
|----------------------------------------------------------------------------|-----------------|-----------------|------------------------------------|--------------------------------------------------------------|------------------------------------------------------------|
| THC
(40 drug-free
40 containing drug) | 9-THC | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | 9-THC | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| Cocaine and Cocaine
Metabolites
(80 drug-free
80 containing drug) | Benzoylecgonine | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| | Cocaine | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| | Morphine | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| | Codeine | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| Opiates
(200 drug-free
178 containing drug) | Oxycodone | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| | Hydrocodone | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | | Containing drug | 18 | 100% (18/18) | 100% (18/18) |
| | 6-AM | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| PCP
(40 drug-free
40 containing drug) | PCP | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| Amphetamine
(40 drug-free
40 containing drug) | Amphetamine | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| Methamphetamine
(40 drug-free
40 containing drug) | Methamphetamine | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| Drug Class | Drug | Sample Type | Number of Samples
for Each Drug | Quantisal II A and B
samples within ±15% of
each other | Quantisal II A/B
Agreement with
Expectorated Samples |
| Buprenorphine
(40 drug-free
40 containing drug) | Buprenorphine | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | Buprenorphine | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| Methadone
(40 drug-free
40 containing drug) | Methadone | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | Methadone | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| Benzodiazepines
(40 drug-free
40 containing drug) | Nordiazepam | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | Nordiazepam | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
| Tramadol
(40 drug-free
40 containing drug) | Tramadol | Drug-Free | 40 | 100% (40/40) | 100% (40/40) |
| | Tramadol | Containing drug | 40 | 100% (40/40) | 100% (40/40) |
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8. Expectorated Oral Fluid Samples Processed Through Quantisal II (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 II device was introduced into each expectorated sample. The next day, Quantisal II samples A and B were analyzed by mass spectrometry. 899/900 paired results meet the criteria that Quantisal II A and B concentrations were within 15% of each other. 899/900 paired results meet the criteria that Quantisal II concentration was within ±20% of the expectoration 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 II collection regardless of drug class. The Quantisal II oral fluid collection device does not introduce bias to quantitative and qualitative results of expectoration neat oral fluid sample (clinical truth).
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H. CONCLUSION
The information provided in this pre-market notification demonstrates that the Immunalysis Quantisal II Oral Fluid Collection Device is substantially equivalent to the legally marketed predicate device for its intended use.