(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.
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July 28, 2023
Immunalysis Corporation Shubhajit Mitra Regulatory Affairs Manager 829 Towne Center Drive Pomona, California 91767
Re: K223781
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 13, 2023 Received: June 14, 2023
Dear Shubhajit Mitra:
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.
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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 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 -S
Marianela Perez-Torres, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics 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) K223781
Device Name
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 drugs of abuse testing. This device is for prescription use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5 510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with 21 CFR Section 807.92.
| 510(k) number: | K223781 |
|---|---|
| Submitter | |
| Applicant Name: | Immunalysis Corporation829 Towne Center DrivePomona, CA 91767 |
| FDA Establishment #: | 2020952 |
| Primary Correspondent: | Shubhajit MitraRegulatory Affairs Manager |
| Primary Phone: | 508-330-4796 |
| Primary Email: | shubhajit.mitra@abbott.com |
| Alternate Correspondent: | Regina XavierAssociate Director, Regulatory Affairs |
| Secondary Phone: | 630-596-6625 |
| Alternate Email: | regina.xavier@abbott.com |
| Date Prepared: | July 27, 2022 |
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5.1 Device Information
| Trade or Proprietary Names: | Quantisal II Oral Fluid Collection Device |
|---|---|
| Common Name: | Quantisal II |
| Device Classification Name: | Oral Fluid Drugs of Abuse and Alcohol Test Specimen CollectionDevice |
| Product Codes: | PJD |
| Regulatory Class: | Class II |
| Classification Regulation: | 21 CFR 862.1675 |
| Panel: | Clinical Chemistry |
Predicate Information
| Company: | Immunalysis Corporation |
|---|---|
| Device: | Quantisal II Oral Fluid Collection Device (K183048) |
5.2 Device Description
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.
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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.
5.3 Indication for Use
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.
5.4 Comparison to Predicate Device
The subject device has the same design and functionality as the predicate device.
| Device Characteristics | Subject Device - Quantisal II Oral FluidCollection Device | Predicate Device(K183048) |
|---|---|---|
| Similarities | ||
| Manufacturer | Immunalysis Corporation | Identical |
| Proprietary Name | Quantisal II Oral Fluid Collection Device | Identical |
| Classification Product Code | PJD | Identical |
| Device Class | II | Identical |
| Regulation Number | 21 CFR 862.1675 | Identical |
| Review Panel | Clinical Chemistry | Identical |
| Material | Cellulose pad, polypropylene stem,preservative buffer, and transport tube | Identical |
| Body Contact | Cellulose pad placed under the tongue for upto 10 mins | Identical |
| Principle | Collecting an oral fluid specimen on acellulose pad and preserving it in a buffersolution contained in a collection tube | Identical |
| Sample Collection | Place cellulose pad under the tongue forcollection until blue dye is visible in thewindow of the stem | Identical |
| Transport Tube | Polypropylene tube containing preservativebuffer | Identical |
| Sample Matrix | Human oral fluid | Identical |
Table 5-1: Device Comparison
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| Device Characteristics | Subject Device - Quantisal II Oral FluidCollection Device | Predicate Device(K183048) |
|---|---|---|
| Collector | Split collector containing two pads and twostems. These two pads can be separated aftercollection into collector 1 and collector 2. | Identical |
| Sample Volume | 1 mL on each pad, 2 mL in total | Identical |
| Intended Use | Intended for use in the collection,preservation, and transport of oral fluidspecimens for drugs of abuse testing. | Identical |
| Differences | ||
| Indication for Use | The Quantisal II Oral Fluid Collection Device isintended for the collection, preservation, andtransport of oral fluid specimens for drugs ofabuse testing. This device is for prescriptionuse only. | The Quantisal II Oral FluidCollection Device is intended forthe collection, preservation, andtransport of oral fluid specimensfor tetrahydrocannabinol (THC),cocaine and its metabolitebenzoylecgonine, morphine,codeine, oxycodone,hydrocodone, 6-acetylmorphine, phencyclidine,amphetamine,methamphetamine,buprenorphine, methadone,benzodiazepines, and tramadol.For prescription Use only. |
5.5 Performance Characteristics
The candidate and predicate device are identical except for the change in the indications for use and the extension of stability claims for some analytes. There is no change to the device design or functionality. The performance data submitted and cleared in K183048 was established using a representative group of analytes that supports the general intended use of the device. The representative drug analytes studied on Quantisal II Oral Fluid Collection Device represent frequently abused drug classes and variable physicochemical properties. The representative drug analytes evaluated for performance of Quantisal II Oral Fluid Collection Device are listed in Table 5-2 below:
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| Representative Drugs | Cutoff Concentration (ng/mL) used forperformance evaluation |
|---|---|
| THC | 4 |
| Benzoylecgonine | 15 |
| Cocaine | 15 |
| Morphine | 30 |
| Codeine | 30 |
| Oxycodone | 30 |
| Hydrocodone | 30 |
| 6-acetylmorphine | 4 |
| Phencyclidine | 10 |
| Amphetamine | 50 |
| Methamphetamine | 50 |
| Buprenorphine | 3 |
| Methadone | 20 |
| Nordiazepam | 5 |
| Tramadol | 50 |
Table 5-2: Representative Drug Analytes
Clinical and analytical performances were established using Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and Gas chromatography—mass spectrometry (GC-MS).
The representative drug analytes are not an inclusive list of targets that could be tested in specimens collected using Quantisal II Oral Fluid Collection Device. As per the Instructions for Use, use of this device for the collection, preservation, and transportation of oral fluid specimens for in vitro diagnostic drug of abuse testing for analytes not listed in table 5-2 should be validated prior to such use..
The following performance studies were performed on the Quantisal II Oral Fluid Collection Device:
5.5.1 Sample Volume
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The performance studies to verify the sample volume collected using Quantisal II Oral Fluid Collection Device were submitted and cleared in K183048.
5.5.2 Sample Collection Time
The performance studies to verify the sample collection time were submitted and cleared in K183048.
5.5.3 Drug Recovery
Drug recovery studies performed on representative drug analytes using Quantisal II Oral Fluid Collection Device were submitted and cleared in K183048.
Borosilicate Glass Vial Stability 5.5.4
This study was performed to verify that the borosilicate glass vial used for collection of expectorated neat oral fluid sample does not affect the drug concentrations and has adequate analytical recovery to serve as the "analytical truth". The study results were submitted and cleared under K183048.
Oral Fluid Sample Stability 5.5.5
The stability of the representative drugs in the oral fluid specimens collected with the Quantisal II Oral Fluid Collection Device was evaluated with low positive samples (+50%) at room temperature (8-25°C) and refrigerated (2-8°C). The stability of drugs in oral fluid specimens was measured by comparing the concentration of the primary (A) specimen and the retained split (B) specimen over time to the initial concentration. Results within ±10% of the initial concentration are listed in Table 5-3. For all other drugs or drug analytes that are not included in the representative drugs identified in Table 5-3, it is recommended to establish sample stability before using Quantisal II Oral Fluid Collection Device for drug of abuse testing.
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| RepresentativeDrugs | Initial Concentration(ng/mL) | A Specimen Stability(within ±10% of the initialconc.) | B Specimen Stability(within ±10% of initial conc.) | |||
|---|---|---|---|---|---|---|
| Pad A | Pad B | 8-25°C | 2-8°C | 8-25°C | 2-8°C | |
| THC | 5.9 | 5.9 | 10 days | 2 months | 10 days | 2 months |
| Benzoylecgonine | 21 | 22 | 10 days | 12 months | 10 days | 12 months |
| Cocaine | 22 | 22 | 5 days | 1 month | 5 days | 1 month |
| Morphine | 44 | 45 | 10 days | 12 months | 10 days | 12 months |
| Codeine | 46 | 47 | 10 days | 12 months | 10 days | 12 months |
| Oxycodone | 46 | 47 | 10 days | 12 months | 10 days | 12 months |
| Hydrocodone | 45 | 45 | 10 days | 12 months | 10 days | 12 months |
| 6-acetylmorphine | 6.0 | 6.0 | 10 days | 12 months | 10 days | 12 months |
| Phencyclidine | 14 | 14 | 10 days | 12 months | 10 days | 12 months |
| Amphetamine | 76 | 75 | 10 days | 12 months | 10 days | 12 months |
| Methamphetamine | 76 | 74 | 10 days | 12 months | 10 days | 12 months |
| Buprenorphine | 4.4 | 4.5 | 10 days | 12 months | 10 days | 12 months |
| Methadone | 30 | 30 | 10 days | 12 months | 10 days | 12 months |
| Nordiazepam | 7.4 | 7.3 | 10 days | 12 months | 10 days | 12 months |
| Tramadol | 73 | 75 | 10 days | 12 months | 10 days | 12 months |
Table 5-3: Oral Fluid Specimens Stability in the Quantisal II
5.5.6 Sample Transportation Stability
Sample Transportation Stability performed on representative drug analytes II Oral Fluid Collection Device was submitted and cleared in K183048.
5.5.7 Clinical Specimens
A study was conducted to demonstrate equivalency between the two collection pads of the Quantisal II Oral Fluid Collection Device and the results were submitted and cleared in K183048. At least forty deidentified, unaltered drug free clinical oral fluid samples and up to forty deidentified, unaltered clinical oral fluid samples containing representative drugs collected by expectoration (spitting) and Quantisal II Oral Fluid Collection Devices were obtained from a clinical research facility. These were analyzed for drugs listed in Table 5-2 using LC-MS/MS or GC/MS. Quantisal II Tube "A" and "B" results were compared to each other. The results from the expectorated neat oral fluid and the Quantisal II Oral Fluid Collection Device collected samples
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matched 100%. If representative drugs were present in samples from both oral fluid expectoration and Quantisal II Oral Fluid Collection Device.
5.5.8 Expectorated Oral Fluid Samples Processed Through Quantisal II (Dipping Study)
A study was conducted to verify that drug concentrations in oral fluid samples collected by Quantisal II Oral Fluid Collection Device are analytically comparable to the neat oral fluid samples collected by expectoration was submitted and cleared in K183048. The samples used in the study were collected from self-reported drug user patients at a clinical research facility. At least 60 oral fluid sample for each of the representative drug listed in Table 5-2. was collected by expectoration into a borosilicate glass vial. An aliquot of each sample was subsequently processed through the Quantisal II Oral Fluid Collection Device by dipping the collection pad into the oral fluid until the volume adequacy indicator turned blue. The expectoration samples and Quantisal II Oral Fluid Collection Device samples were assayed by LC-MS/MS or GC-MS. The results showed that the 899/900 Quantisal II Oral Fluid Collection Device samples had concentrations that were within ±20% of expectoration concentration.
5.6 Substantial Equivalence
Quantisal II Oral Fluid Collection Device is substantially equivalent to the predicate device. Both devices are intended to be used for collection, preservation, and transport of oral fluid for drug of abuse testing. Both devices are identical in design, materials and functionality. Both devices, using the same performance data set, have demonstrated safety and efficacy for the intended use regardless of the drug analyte tested.
5.7 Conclusion
The information provided in this pre-market notification demonstrates that the Quantisal II Oral Fluid Collection Device is substantially equivalent to the legally marketed predicate device for its Section 5: 510(k) Summary Page 8 of 9
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intended use for collection, preservation, and transport of oral fluid for drug of abuse testing regardless of the analyte being tested.
§ 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.