(64 days)
Not Found
No
The device description and performance studies focus on the physical collection and preservation of oral fluid, with no mention of AI or ML for analysis or interpretation.
No
This device is for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing, not for therapeutic purposes.
No.
This device is a collection device for diagnostic testing, not a diagnostic device itself.
No
The device description clearly outlines physical components (cellulose pad, polypropylene stem, polypropylene tube, cap) and a physical mechanism for collection and preservation of oral fluid. There is no mention of software as a component or function of the device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "collection, preservation and transport of oral fluid specimens for drugs of abuse testing." This indicates the device is used to collect a biological specimen for subsequent testing outside of the body (in vitro).
- Device Description: The description details how the device collects oral fluid and prepares it for testing.
- Performance Studies: The performance studies described (Sample Volume, Sample Collection Time, Drug Recovery, Oral Fluid Sample Stability, Sample Transportation Stability, Clinical Specimen Study) are all related to the performance of the device in collecting and preserving a specimen for diagnostic testing.
- Clinical and analytical performance: The mention of establishing performance using LC-MS/MS and GC-MS further supports its use in a laboratory setting for diagnostic analysis.
While the device itself is a collection and preservation tool, its purpose is directly tied to enabling in vitro diagnostic testing of the collected oral fluid.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
PJD
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.
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.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Clinical and analytical performance were established using Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and Gas chromatography-mass spectrometry (GC-MS).
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.
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.
5.5 Oral Fluid Sample Stability: 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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).
1
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
2
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 Corporation |
| 829 Towne Center Drive | |
| Pomona, CA 91767 | |
| FDA Establishment #: | 2020952 |
| Primary Correspondent: | Shubhajit Mitra |
| Regulatory Affairs Manager | |
| Primary Phone: | 508-330-4796 |
| Primary Email: | shubhajit.mitra@abbott.com |
| Alternate Correspondent: | Iris Saliba |
| Associate 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™ Oral
Fluid Collection Device | Predicate Device (K200801) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Similarities | | |
| Manufacturer | Immunalysis Corporation | Identical |
| Proprietary Name | Quantisal™ 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 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 is visible
in the window of the stem | Identical |
| Transport Tube | Polypropylene tube containing
preservative 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™ Oral
Fluid Collection Device | Predicate Device (K200801) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use in the collection,
preservation, and transport of oral
fluid specimens for drugs of abuse
testing | Identical |
| Differences | | |
| 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. | 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,
methamphetamine, buprenorphine,
methadone, benzodiazepines and
tramadol. 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 for
performance 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 at
8-25°C | Stability at
2-8°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 at
8-25°C | Stability at
2-8°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.