Quantisal Oral Fluid Collection Device
Device Facts
| Record ID | K232898 |
|---|---|
| Device Name | Quantisal Oral Fluid Collection Device |
| Applicant | Immunalysis Corporation |
| Product Code | PJD · Clinical Chemistry |
| Decision Date | Nov 21, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
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.
Device Story
The Quantisal™ Oral Fluid Collection Device is a manual specimen collection tool used in clinical settings. It consists of a cellulose pad attached to a polypropylene stem and a transport tube containing 3 mL of preservative buffer. A clinician or operator places the pad under the patient's tongue until a blue indicator in the stem window confirms saturation (1 mL of oral fluid). The pad is then transferred to the transport tube, resulting in a 1:4 dilution. The device preserves the specimen for subsequent laboratory analysis (e.g., LC-MS/MS or GC-MS) to detect drugs of abuse. It facilitates standardized sample collection and maintains analyte stability during transport to a laboratory, aiding healthcare providers in identifying drug use.
Clinical Evidence
No clinical data. Bench testing only. Stability studies performed to validate extended refrigerated storage claims for THC, benzoylecgonine, cocaine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines, and tramadol. Previous drug recovery and sample volume data from K200801 cited as supporting evidence.
Technological Characteristics
Materials: cellulose pad, polypropylene stem, preservative buffer, polypropylene transport tube. Principle: passive absorption of oral fluid until volume saturation indicated by color change. Form factor: handheld collector with transport tube. Connectivity: none. Sterilization: not specified. Software: none.
Indications for Use
Indicated for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing in patients requiring such testing. Prescription use only.
Regulatory Classification
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.
Predicate Devices
- Quantisal™ Oral Fluid Collection Device (K200801)
Related Devices
- K200801 — Quantisal Oral Fluid Collection Device · Immunalysis Corporation · Jul 28, 2020
- K183048 — Quantisal II Oral Fluid Collection Device · Immunalysis Corporation · Jul 29, 2019
Submission Summary (Full Text)
{0}
FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K232898
B Applicant
Immunalysis Corporation
C Proprietary and Established Names
Quantisal™ Oral Fluid Collection Device
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PJD | Class II | 21 CFR 862.1675 - Blood Specimen Collection Device | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Modification to an existing device.
B Measurand:
Not applicable.
C Type of Test:
For the collection, preservation, and transport of oral fluid specimens with drugs of abuse testing.
## III Intended Use/Indications for Use:
A Intended Use(s):
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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See Indications for Use below.
## B Indication(s) 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.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
The Quantisal Oral Fluid Collection Devices has been previously cleared for the measurement of THC, Benzoylecgonine, Cocaine, Morphine, Codeine, Oxycodone, Hydrocodone, 6-acetylmorphine, Phencyclidine, Amphetamine, Methamphetamine, Buprenorphine, Methadone, Benzodiazepines and Tramadol. Use of the device for the collection, preservation, and transport of any other analyte for drugs of abuse testing should be validated prior to such use.
## D Special Instrument Requirements:
Not applicable.
## IV Device/System Characteristics:
### A 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 Quantisal device is designed to collect 1 mL ± 10% oral fluid sample. Each device contains (a) cellulose pad affixed to a polypropylene stem and (b) one transportation tube.
### B Principle of Operation:
The Quantisal device is designed to collect 1 mL ± 10% oral fluid sample. Each device contains a collector made up of a cellulose pad with cellulose extending into the interior of a polypropylene stem. Blue dye is pre-applied to the cellulose inside the stem. When the cellulose pad is placed under the tongue of a donor, oral fluid is collected via passive diffusion. Upon saturating the cellulose pad, oral fluid migrates along the cellulose tail through capillary action and dissolves the dye. As oral fluid collection continues, the dye becomes visible in the window on the stem. Specimen collection is complete when the window is completely blue. The collector is then removed from the mouth. The pad is transferred into provided polypropylene transport tube which contains 3 mL of preservative buffer. The preservative buffer serves as a reservoir into which analytes may distribute, permitting recovery of analytes from the pad during the time the specimens are in storage or being transported.
The Quantisal device collects 1 mL sample of neat oral fluid and dilutes it with 3 mL of preservative buffer in each tube. This results in a 1 to 4 dilution factor.
### V Substantial Equivalence Information:
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A Predicate Device Name(s):
Quantisal™ Oral Fluid Collection Device
B Predicate 510(k) Number(s):
K200801
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K232898 | K200801 |
| --- | --- | --- |
| Device Trade Name | Quantisal™ Oral Fluid Collection Device | Same |
| General Device Characteristic Similarities | | |
| Intended Use/Indications for Use | For the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. | Same |
| Materials | Cellulose pad, polypropylene stem, preservative buffer and transport tube | Same |
| Body Contact | Cellulose pad placed under the tongue for up to 10 minutes | Same |
| Sample Collection | A cellulose pad is placed 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 |
| Collector | Collector containing one pad | Same |
| Sample Volume | 1 mL | Same |
| General Device Characteristic Differences | | |
| Refrigerated Sample Stability | Benzoylecgonine, Morphine, Codeine, Oxycodone, Hydrocodone, 6-Acetylmorphine, | Benzoylecgonine, Morphine, Codeine, Oxycodone, Hydrocodone, 6-Acetylmorphine, Phencyclidine, |
K232898 - Page 3 of 7
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| | Phencyclidine, Amphetamine, Methamphetamine, Buprenorphine, Methadone, Benzodiazepines, and Tramadol are stable for 12 months when stored refrigerated (2-8°C, 36-46°F).
THC is stable for 2 months and Cocaine for 1 month when stored refrigerated (2-8°C, 36-46°F). | Amphetamine, Methamphetamine, Buprenorphine, Methadone, Benzodiazepines, and Tramadol are stable for 3 months when stored refrigerated (2-8°C, 36-46°F)
The stability of THC and Cocaine are the same. |
| --- | --- | --- |
VI Standards/Guidance Documents Referenced:
None.
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Not applicable.
2. Linearity:
Not applicable.
3. Analytical Specificity/Interference:
Not applicable.
4. Assay Reportable Range:
Not applicable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Sample Volume
Data submitted in k200801 to support that a consistent sample volume is collected supports the sample volume claims for the candidate device.
Sample Collection Time
K232898 - Page 4 of 7
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Data submitted in k200801 to support a consistent sample collection time supports the sample collection time claims for the candidate device.
## Drug Recovery
The sponsor previously provided in k200801 drug recovery data for THC, benzoylecgonine, cocaine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, nordiazepam, and tramadol which support the drug recovery claims for the candidate device. Use of this device with a drugs of abuse assay intended to measure any other analytes must be validated prior to such use.
## Oral Fluid Sample Stability
The sponsor evaluated the stability of the previously cleared analytes and extended their stability claims as follows:
Based upon these results, the sponsor has the following stability:
| 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 |
| 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 |
Use of this device with a drug of abuse assay intended to measure any other analytes must be validated by the assay manufacturer prior to such use.
## Clinical Specimens Testing
The sponsor previously provided in k200801 information on the device performance versus expectoration for THC, benzoylecgonine, cocaine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines, and tramadol which also supports the performance versus expectoration claims for the candidate device.
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Use of this device with a drugs of abuse assay intended to measure any other analytes must be validated by the assay manufacturer prior to such use.
## Biocompatibility
The duration of body contact, materials of construction, design, physico-chemical properties and the manufacturing method of Quantisal™ Oral Fluid Collection Device is identical to the predicate device k200801.
6. Detection Limit:
Not applicable.
7. Assay Cut-Off:
Not applicable.
## B Comparison Studies:
1. Method Comparison with Predicate Device:
Not applicable.
2. Matrix Comparison:
Not applicable.
## C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
## D Clinical Cut-Off:
Not applicable.
## E Expected Values/Reference Range:
Not applicable.
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VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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