(64 days)
The Quantisal™ 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™ 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 cellulose pad 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 pad is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then transferred into a polypropylene tube (provided) containing 3 mL of preservative buffer. The tube is stoppered with provided cap. The specimen is ready for storage and transport.
The Quantisal™ 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 Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The subject device is substantially equivalent to the predicate device (K200801) as they share the same design, materials, and functionality. The primary difference lies in the updated "Indications for Use" to broaden the scope beyond a specific list of drugs, relying on the established performance data of representative analytes from the predicate device.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance is based on the substantial equivalence to a legally marketed predicate device (K200801) and the device's ability to maintain the stability of various drug analytes in oral fluid samples. The acceptance criteria are implicitly related to maintaining drug stability and collection efficiency demonstrated in the previous submission.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Device Performance | Sample Volume Collected (1 mL) | Performance studies to verify this were submitted and cleared in K200801. |
| Sample Collection Time (until blue dye visible) | Performance studies to verify this were submitted and cleared in K200801. | |
| Drug Recovery (for representative analytes) | Studies performed on representative drug analytes using Quantisal™ Oral Fluid Collection Device were submitted and cleared in K200801. | |
| Oral Fluid Sample Stability (8-25°C) | THC: 10 days; Benzoylecgonine: 10 days; Cocaine: 5 days; Morphine: 10 days; Codeine: 10 days; Oxycodone: 10 days; Hydrocodone: 10 days; 6-acetylmorphine: 10 days; Phencyclidine: 10 days; Amphetamine: 10 days; Methamphetamine: 10 days; Buprenorphine: 10 days; Methadone: 10 days; Benzodiazepines: 10 days; Tramadol: 10 days. | |
| Oral Fluid Sample Stability (2-8°C) | THC: 2 months; Benzoylecgonine: 12 months; Cocaine: 1 month; Morphine: 12 months; Codeine: 12 months; Oxycodone: 12 months; Hydrocodone: 12 months; 6-acetylmorphine: 12 months; Phencyclidine: 12 months; Amphetamine: 12 months; Methamphetamine: 12 months; Buprenorphine: 12 months; Methadone: 12 months; Benzodiazepines: 12 months; Tramadol: 12 months. | |
| Sample Transportation Stability | Studies performed on representative drug analytes using Quantisal™ Oral Fluid Collection Device were submitted and cleared in K200801. | |
| Methodology | Acceptable Analytical Method for Drug Detection and Quantification | Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and Gas chromatography-mass spectrometry (GC-MS) for performance evaluation. |
| Intended Use Generalization | Applicability to "drugs of abuse testing" beyond specific analytes listed | The device demonstrated safety and efficacy for a representative group of analytes (THC, Benzoylecgonine, Cocaine, Morphine, Codeine, Oxycodone, Hydrocodone, 6-acetylmorphine, Phencyclidine, Amphetamine, Methamphetamine, Buprenorphine, Methadone, Benzodiazepines, Tramadol) and their concentrations. This supports generalization, with the caveat that new analytes require validation by the user. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to performance studies submitted and cleared in K200801 for sample volume, collection time, drug recovery, and clinical specimen studies. For the extended refrigerated sample stability, the samples were low positive samples (+50% cutoff). The exact number of samples used for each test (sample size for the test set) is not explicitly stated in this document, as it refers back to the K200801 submission. The provenance of the data (country of origin, retrospective/prospective) and detailed sample sizes are also not provided in this document but would have been part of the K200801 submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the current 510(k) summary. The ground truth for drug detection and quantification would typically be established by the analytical methods themselves (LC-MS/MS, GC-MS), which are considered definitive. Expert interpretation might come into play during method development or result validation, but details are not given here.
4. Adjudication Method for the Test Set
This information is not applicable in the context of analytical device performance studies where objective measurements (e.g., drug concentrations by LC-MS/MS or GC-MS) establish the "ground truth." Adjudication methods like 2+1 or 3+1 are typically used in image-based diagnostic studies involving human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not applicable and therefore not done. This device is an oral fluid collection device, not an AI-assisted diagnostic tool that requires human interpretation. The performance relates to its ability to collect and preserve samples for subsequent laboratory analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the device is a collection device, not an algorithm. Its performance is evaluated based on its physical properties for collection, preservation, and chemical stability of the analytes.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations (drug recovery, stability) was established using definitive analytical methods: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and Gas chromatography-mass spectrometry (GC-MS). These methods are considered the gold standard for identifying and quantifying drugs, serving as the "pathology" equivalent in this context.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. As a physical collection device, it does not rely on machine learning or algorithms that require training data. All mentioned studies are performance evaluations.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Immunalysis Corporation Shubhajit Mitra Regulatory Affairs Manager 829 Towne Center Drive Pomona, California 91767
Re: K232898
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: September 18, 2023 Received: September 18, 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Joseph A. Digitally signed by Kotarek -S Date: 2023.11.21
14:08:41 -05'00'
Josepk Kotarek, Ph.D. Toxicology Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics 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) K232898
Device Name Quantisal™ Oral Fluid Collection Device
Indications for Use (Describe)
The Quantisal™ 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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Image /page/3/Picture/0 description: The image shows the logo for Abbott. The logo consists of a stylized, sans-serif letter 'A' in blue, positioned above the name 'Abbott' in a bold, black, sans-serif font. The 'A' symbol is simple and modern, and the overall design is clean and corporate.
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: | K232898 |
|---|---|
| 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: | Iris SalibaAssociate Director, Regulatory Affairs |
| Secondary Phone: | 619-540-3931 |
| Alternate Email: | iris.saliba@abbott.com |
| Date Prepared: | Nov 3, 2023 |
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5.1 Device Information
| Trade or Proprietary Names: | QuantisalTM Oral Fluid Collection Device |
|---|---|
| Common Name: | QuantisalTM |
| Device Classification Name: | Oral Fluid Drugs of Abuse and Alcohol Test Specimen Collection Device |
| Product Codes: | PJD |
| Regulatory Class: | Class II |
| Classification Regulation: | 21 CFR 862.1675 |
| Panel: | Clinical Chemistry |
Predicate Information
| Company: | Immunalysis Corporation |
|---|---|
| Device: | Quantisal™ Oral Fluid Collection Device (K200801) |
5.2 Device Description
The Quantisal™ 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 cellulose pad 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 pad is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then transferred into a polypropylene tube (provided) containing 3 mL of preservative buffer. The tube is stoppered with provided cap. The specimen is ready for storage and transport.
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Image /page/5/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized letter 'a' in blue, positioned above the company name 'Abbott' in black, sans-serif font. The 'a' symbol is a rounded, geometric shape, and the overall design is clean and modern.
The Quantisal™ 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™ 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™ OralFluid Collection Device | Predicate Device (K200801) |
|---|---|---|
| Similarities | ||
| Manufacturer | Immunalysis Corporation | Identical |
| Proprietary Name | Quantisal™ Oral Fluid CollectionDevice | 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 transporttube | Identical |
| Body Contact | Cellulose pad placed under thetongue for up to 10 mins | Identical |
| Principle | Collecting an oral fluid specimen ona cellulose pad and preserving it in abuffer solution contained in acollection tube | Identical |
| Sample Collection | Place cellulose pad under the tonguefor collection until blue dye is visiblein the window of the stem | Identical |
| Transport Tube | Polypropylene tube containingpreservative buffer | Identical |
| Sample Matrix | Human oral fluid | Identical |
| Collector | Collector containing a pad | Identical |
| Sample Volume | 1 mL | Identical |
Table 5-1: Device Comparison
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| Device Characteristics | Subject Device - Quantisal™ OralFluid Collection Device | Predicate Device (K200801) |
|---|---|---|
| Intended Use | Intended for use in the collection,preservation, and transport of oralfluid specimens for drugs of abusetesting | Identical |
| Differences | ||
| Indication for Use | The Quantisal™ Oral Fluid CollectionDevice is intended for the collection,preservation, and transport of oralfluid specimens for drugs of abusetesting. This device is forprescription use only. | The Quantisal™ Oral Fluid CollectionDevice is intended for the Collection,preservation and transport of oralfluid specimens fortetrahydrocannabinol (THC), cocaineand its metabolite benzoylecgonine,morphine, codeine, oxycodone,hydrocodone, 6-acetylmorphine,phencyclidine, amphetamine,methamphetamine, buprenorphine,methadone, benzodiazepines andtramadol. For prescription Use only. |
5.5 Performance Characteristics
The subject and predicate device are similar except for 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 K200801 was established using a representative group of analytes that supports the general intended use of the device. The representative drug analytes studied on Quantisal™ represent frequently abused drug classes and variable physicochemical properties. The representative drug analytes evaluated for performance of Quantisal™ Oral Fluid Collection Device are listed in Table 5-2 below:
| Representative Drugs | Cutoff Concentration (ng/mL) used forperformance evaluation |
|---|---|
| THC | 4 |
| Benzoylecgonine | 15 |
| Cocaine | 15 |
| Morphine | 30 |
| Codeine | 30 |
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Image /page/7/Picture/1 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized letter "a" in blue, positioned above the company name "Abbott" in black, sans-serif font. The "a" symbol is a rounded, geometric shape. The overall design is clean and modern.
| Representative Drugs | Cutoff Concentration (ng/mL) used for performance evaluation |
|---|---|
| Oxycodone | 30 |
| Hydrocodone | 30 |
| 6-acetylmorphine | 4 |
| Phencyclidine | 10 |
| Amphetamine | 50 |
| Methamphetamine | 50 |
| Buprenorphine | 3 |
| Methadone | 20 |
| Benzodiazepines(Nordiazepam) | 5 |
| Tramadol | 50 |
Clinical and analytical performance 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™. 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 5-1must be validated prior to such use. The following performance studies were performed on the Quantisal™:
5.5.1 Sample Volume
The performance studies to verify the sample volume collected using Quantisal™ were submitted and cleared in K200801.
5.5.2 Sample Collection Time
The performance studies to verify the sample collection time were submitted and cleared in K200801.
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Image /page/8/Picture/0 description: The image shows the text "Quantisal™ Oral Fluid Collection Device" in blue font. Below this text, the words "Premarket Notification" are written in a smaller, black font. The text appears to be part of a document or presentation slide.
Image /page/8/Picture/1 description: The image contains the logo for Abbott, a healthcare company. The logo features a stylized, abstract letter 'A' in blue, positioned above the company name 'Abbott' in black, sans-serif font. The 'A' symbol is composed of interconnected, rounded shapes, giving it a modern and clean appearance. The overall design is simple, recognizable, and conveys a sense of professionalism and trust.
5.5.3 Drug Recovery
Drug recovery studies performed on representative drug analytes using Quantisal™ Oral Fluid Collection Device were submitted and cleared in K200801.
Oral Fluid Sample Stability 5.5
The stability of the representative drugs in the oral fluid specimens collected with the Quantisal™ Oral Fluid Collection Device was evaluated with low positive samples (+50%) cutoff at room temperature (8-25°C) and refrigerated (2-8°C). Sample Stability testing was performed using LC-MS/MS or GC/MS at multiple timepoints post collection at 8℃ - 25℃ and at 2℃ - 8℃. The stability results of the representative analytes from K200801 and refrigerated sample stability extension results in this submission are presented in Table 5-3.
| Drugs | Initial Concentration(ng/mL) | Stability at8-25°C | Stability at2-8°C |
|---|---|---|---|
| THC | 6.0 | 10 days | 2 months |
| Benzoylecgonine | 22 | 10 days | 12 months |
| Cocaine | 22 | 5 days | 1 month |
| Morphine | 45 | 10 days | 12 months |
| Codeine | 46 | 10 days | 12 months |
| Oxycodone | 47 | 10 days | 12 months |
| Hydrocodone | 46 | 10 days | 12 months |
| 6-acetylmorphine | 5.8 | 10 days | 12 months |
| Phencyclidine | 14 | 10 days | 12 months |
| Amphetamine | 75 | 10 days | 12 months |
| Methamphetamine | 74 | 10 days | 12 months |
Table 5-3: Oral Fluid Specimens Stability in the Quantisal™
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| Drugs | Initial Concentration(ng/mL) | Stability at8-25°C | Stability at2-8°C |
|---|---|---|---|
| Buprenorphine | 4.5 | 10 days | 12 months |
| Methadone | 29 | 10 days | 12 months |
| Benzodiazepines | 7.5 | 10 days | 12 months |
| Tramadol | 75 | 10 days | 12 months |
5.5.6 Sample Transportation Stability
Sample Transportation Stability performed on representative drug analytes using Quantisal™ Oral Fluid Collection Device was submitted and cleared in K200801.
5.5.7 Clinical Specimen Study
Clinical specimen testing performed on the representative analytes listed in Table 5-2 using Quantisal Oral Fluid Collection Device was submitted and cleared in K200801.
5.6 Substantial Equivalence
Quantisal™ 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 have same 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™ Oral Fluid Collection Device is substantially equivalent to the legally marketed predicate device for its Section 5: 510(k) Summary Page 7 of 8
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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.