Quantisal™ II Oral Fluid Collection Device

K223781 · Immunalysis Corporation · PJD · Jul 28, 2023 · Clinical Chemistry

Device Facts

• Record ID: K223781
• Device Name: Quantisal™ II Oral Fluid Collection Device
• Applicant: Immunalysis Corporation
• Product Code: PJD · Clinical Chemistry
• Decision Date: Jul 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Indications 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.

Device Story

Quantisal™ II is a split oral fluid collection device consisting of two cellulose pads on a polypropylene stem. The device is placed under the tongue until a volume adequacy indicator (blue color) appears in a window on the stem. The collector is then separated into two pads/stems and transferred into two separate polypropylene tubes containing 3 mL of preservative buffer each. This allows for simultaneous collection of two aliquots: one for screening/confirmation and one for retention. The device is used in clinical settings by healthcare professionals to collect specimens for subsequent laboratory analysis (LC-MS/MS or GC-MS). By providing a standardized collection and preservation method, the device ensures sample integrity for drug testing, facilitating accurate clinical decision-making regarding substance use.

Clinical Evidence

No new clinical data provided. Performance claims for sample volume, collection time, drug recovery, and Pad A vs. Pad B consistency rely on data previously submitted in K183048. Stability testing was performed to extend refrigerated storage claims for 15 analytes.

Technological Characteristics

Materials: cellulose pads, polypropylene stem, preservative buffer. Sensing: passive diffusion and capillary action with visual dye indicator. Form factor: split collector with two 1 mL pads. Connectivity: none. Sterilization: not specified.

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 II Oral Fluid Collection Device (K183048)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K223781

B Applicant

Immunalysis Corporation

C Proprietary and Established Names

Quantisal™ II 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:

Collection, preservation, and transport of oral fluid specimens for drugs of abuse testing.

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) 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.

C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

The Quantisal II Oral Fluid Collection Devices has been previously cleared for the measurement of THC, Benzoylecgonine, 6-acetylmorphine, Phencyclidine, Amphetamine, Methamphetamine, Buprenorphine, Methadone, Nordiazepam, 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™ II Oral Fluid Collection Device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The Quantisal II device simultaneously collects two 1 mL ± 10% oral fluid samples. Each device contains a split collector made up of two cellulose pads affixed to a two component polypropylene stem and two transportation tubes (labelled A and B).

B Principle of Operation:
The Quantisal II device is designed to simultaneously collect two oral fluid samples. Each device contains a split collector made up of two cellulose pads with cellulose extending into the interior of a two-component polypropylene stem. Blue dye is pre-applied to the cellulose inside the stem. When the cellulose pads are 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 windows on the stem. Specimen collection is complete when the windows are completely blue on both sides of the stem. The device stem is split into two separate components, collector 1 and collector 2, each of which contains one half of the stem and a single pad saturated with of oral fluid. The separated pads are transferred into provided polypropylene transport tubes (Tube A and Tube B) which contain 3 mL of preservative buffer each. 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.

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V Substantial Equivalence Information:

A Predicate Device Name(s):
Quantisal II Oral Fluid Collection Device

B Predicate 510(k) Number(s):
K183048

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K223781 | K183048 |
| --- | --- | --- |
| Device Trade Name | Quantisal II 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 |
| Sample Matrix | Human oral fluid | Same |
| Sample Volume | 1 mL on each pad, 2 mL in total | Same |
| Materials | Cellulose pad, polypropylene stem, preservative buffer, and transport tube | Same |
| Contact with human tissue | Cellulose pad placed under the tongue for up to 10 ins | Same |
| Transport Tube | Polypropylene tube containing preservative buffer | Same |
| General Device Characteristic Differences | | |
| Refrigerated Sample stability | Benzoylecgonine, Morphine, Codeine, Oxycodone, Hydrocodone, 6-acetylmorphine, Phencyclidine, Amphetamine, Methamphetamine, Buprenorphine, Methadone, Nordiazepam, and Tramadol are stable for 12 months when stored refrigerated (2-8°C; 36-46°F). | THC, Benzoylecgonine, Morphine, Codeine, Oxycodone, Hydrocodone, 6-acetylmorphine, Phencyclidine, Amphetamine, Methamphetamine, Buprenorphine, Methadone, Nordiazepam , |

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| Device & Predicate Device(s): | K223781 | K183048 |
| --- | --- | --- |
| | THC is stable for 2 months when stored refrigerated (2-8°C; 36-46°F) | and Tramadol are stable for up to one month when stored refrigerated (2-8°C; 36-46°F) |

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 k183048 to support that a consistent sample volume is collected supports the sample volume claims for the candidate device.

Sample Collection Time

Data submitted in k183048 to support a consistent sample collection time supports the sample collection time claims for the candidate device.

Drug Recovery

The sponsor previously provided in k183048 drug recovery data for THC, benzoylecgonine, cocaine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, nordiazepam, and tramadol

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which supports 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 has extended their stability claims as follows:

| Analyte | Pad A Specimen Stability | | Pad B Specimen Stability | |
| --- | --- | --- | --- | --- |
| | 8-25°C | 2-8°C | 8-25°C | 2-8°C |
| THC | 10 days | 2 months | 10 days | 2 months |
| Benzoylecgonine | 10 days | 12 months | 10 days | 12 months |
| Cocaine | 5 days | 1 month | 5 days | 1 month |
| Morphine | 10 days | 12 months | 10 days | 12 months |
| Codeine | 10 days | 12 months | 10 days | 12 months |
| Oxycodone | 10 days | 12 months | 10 days | 12 months |
| Hydrocodone | 10 days | 12 months | 10 days | 12 months |
| 6-acetylmorphine | 10 days | 12 months | 10 days | 12 months |
| Phencyclidine | 10 days | 12 months | 10 days | 12 months |
| Amphetamine | 10 days | 12 months | 10 days | 12 months |
| Methamphetamine | 10 days | 12 months | 10 days | 12 months |
| Buprenorphine | 10 days | 12 months | 10 days | 12 months |
| Methadone | 10 days | 12 months | 10 days | 12 months |
| Nordiazepam | 10 days | 12 months | 10 days | 12 months |
| Tramadol | 10 days | 12 months | 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 k183048 information on the device performance versus expectoration for THC, benzoylecgonine, cocaine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, nordiazepam, and tramadol which also supports the performance versus expectoration claims for the candidate device.

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The sponsor previously provided in k183048 Pad A versus pad B data for THC, benzoylecgonine, cocaine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, nordiazepam, and tramadol which also supports the Pad A versus Pad B claims for the candidate device.

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™ II Oral Fluid Collection Device is identical to the predicate device k183048.

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.

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E Expected Values/Reference Range:

Not applicable.

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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