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, buprenorphine, methadone, benzodiazepines and tramadol.

Device Description

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, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines and tramadol. This device is for prescription use only.

An oral fluid specimen is collected by placing a cellulose pad affixed to a polypropylene stem (Collector) 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 transferred into a provided polypropylene tube containing a specific volume of preservative buffer. The tube is stoppered with provided caps. The specimen is ready for storage or transport.

The Quantisal Oral Fluid Collection System collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer. This results in a 1 to 4 dilution factor.

Immunalysis Quantisal Oral Fluid Collection Device is sold as a stand-alone collection device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Quantisal™ Oral Fluid Collection Device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
1. Sample Volume Consistency	The implicit criterion is that the collected sample volume should be consistent at 1 mL, as indicated by the blue coloration in the collector stem's window.	The results confirmed consistency of sample volume of 1 mL collected by the Quantisal collector.
2. Sample Collection Time	The implicit criterion is that the collection time should be within the claimed time of 10 minutes for a high percentage of subjects.	The results verified the sample collection time for Quantisal Oral Fluid Collection Device is within the claimed time of 10 minutes in over 90% of subjects.
3. Drug Recovery	Greater than 80% recovery of the original drug concentration after overnight storage at room temperature. (This is inferred from the statement that the studies demonstrated recovery greater than 80%). The document does not explicitly state this as an acceptance criterion but as a demonstrated outcome.	Recovered tested drugs at greater than 80% of the original concentration for all drugs listed (THC, Benzoylecgonine, Cocaine, Morphine, Codeine, Oxycodone, Hydrocodone, 6-acetylmorphine, Phencyclidine, Amphetamine, Methamphetamine, Buprenorphine, Methadone, Benzodiazepines, Tramadol).
4. Oral Fluid Sample Extraction Efficiency	Minimum acceptance criterion of >80% drug recovery at 4 hours post-collection, and >90% at 24 hours for complete extraction.	Met the minimum acceptance criterion of >80% at 4 hours post-collection for all drugs and reached >90% at 24 hours for all drugs to show a complete extraction.
4. Oral Fluid Sample Stability	Data is presented in Table 2, showing stability for specified durations at different temperatures (8-25°C and 2-8°C). The implicit criterion is that drugs remain stable for these durations. Specific quantitative criteria are not stated for stability (e.g., within X% of initial concentration), but the results presented indicate meeting these stability claims.	Stability at 8-25°C: 5 to 10 days depending on the drug. Stability at 2-8°C: 1 to 3 months depending on the drug. (See Table 2 for full details).
5. Sample Transportation Stability	Drug concentration of the sample collected by Quantisal Oral Fluid Collection Device is within 20% of the reference value during transportation.	Demonstrated the drug concentration of the sample collected by Quantisal Oral Fluid Collection Device is within 20% of the reference value during transportation for a 4-day (96 hours) simulated study and a 24-hour supplemental study at various temperatures.
6. Borosilicate Glass Vial Stability	Drug loss of the samples collected by borosilicate glass vial was within ±10% of the initial value after 48 hours storage at 25°C.	The drug loss of the samples collected by borosilicate glass vial was within ±10% of the initial value after 48 hours storage at 25°C.
7. Expectorated Oral Fluid Samples Processed Through Quantisal (Dipping Study)	Quantisal concentration was within ±20% of the expectorated result.	899/900 paired results met the criteria that Quantisal concentration was within ±20% of the expectorated result. The study demonstrated no difference in drug concentrations.
8. Drug-Free Clinical Specimens Accuracy	The results of all expectorated samples and Quantisal samples are negative for each drug. (Implicitly, 100% accuracy for drug-free samples).	All expectorated samples and Quantisal samples were negative for each drug. The study demonstrated the accuracy of the Quantisal Oral Fluid Collection Device when collecting drug-free clinical specimens.

2. Sample Size Used for the Test Set and Data Provenance

Sample Volume Consistency: 75 oral fluid samples from known drug users. Data provenance is not specified beyond "known drug users." This sounds like prospective collection for the study.
Sample Collection Time: 75 oral fluid samples from known drug users. Data provenance is not specified beyond "known drug users." This sounds like prospective collection for the study.
Drug Recovery: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples, not human subjects.
Oral Fluid Sample Extraction Efficiency and Stability: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
Sample Transportation Stability: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
Borosilicate Glass Vial Stability: Drug-free expectorated oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
Expectorated Oral Fluid Samples Processed Through Quantisal (Dipping Study): At least 60 de-identified, unaltered drug-containing oral fluid samples. Provenance is "collected by expectoration (spitting) at clinical research facility." This indicates prospective collection of clinical samples.
Drug Free Clinical Specimens: At least 40 de-identified, unaltered drug-free clinical oral fluid samples. Provenance is "obtained from clinical research facility." This indicates prospective collection of clinical samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

No specific information is provided regarding the number or qualifications of experts for establishing ground truth.
For spiked samples, the "ground truth" is the known concentration of the spiked drugs, as determined by laboratory methods.
For clinical samples (Dipping Study and Drug-Free Clinical Specimens), the ground truth was established by LC-MS/MS or GC-MS analysis of the expectorated (neat) oral fluid samples, which are high-accuracy analytical methods typically used in forensic or clinical toxicology laboratories. This is considered an analytical ground truth rather than an expert consensus based on visual assessment or interpretation.

4. Adjudication Method for the Test Set

Not applicable as this is a device for specimen collection and preservation, with performance evaluated by objective analytical methods (LC-MS/MS, GC-MS) rather than subjective human assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation devices where human readers are involved in making decisions, and the AI's impact on human performance is assessed. This device is a collection tool, not an interpretive one.

6. Standalone (Algorithm Only) Performance

This device is not an algorithm or AI in the traditional sense. It's a physical collection device. Its "standalone" performance refers to its ability to collect, preserve, and transport samples effectively, and this was evaluated by the various laboratory performance studies (e.g., drug recovery, stability, comparison to expectorated samples). The analytical tests (LC-MS/MS, GC-MS) were performed on the collected samples to determine the device's performance.

7. The Type of Ground Truth Used

Analytical Ground Truth:
- For spiked samples and stability studies: The known concentration of drugs in the prepared solutions.
- For clinical samples (Dipping Study and Drug Free Clinical Specimens): The drug concentrations (or absence of drugs) as determined by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GC-MS) of the neat/expectorated oral fluid. These are highly accurate, gold-standard analytical methods for drug quantification and identification.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or algorithms. It is a physical device, and its performance is evaluated through a series of analytical and clinical studies as described.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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July 28, 2020

Immunalysis Corporation Wenying (Jessica) Zhu Manager, Regulatory Affairs 829 Towne Center Drive Pomona, CA 91767

Re: K200801

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: June 26, 2020 Received: June 30, 2020

Dear Wenying (Jessica) Zhu:

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.

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

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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, M.T., Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K200801

Device Name Quantisal™ Oral Fluid Collection Device

Indications for Use (Describe)

For In Vitro Diagnostic Use

Type of Use (Select one or both, as applicable)
❌ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

A. GENERAL INFORMATION

Applicant Name:	Immunalysis Corporation829 Towne Center DrivePomona, CA 91767Establishment # 2020952
Company Contact:	Wenying (Jessica) ZhuManager, Regulatory AffairsPhone: (909) 451-6697Email: wzhu@immunalysis.com
Date Prepared:	July 23, 2020

B. DEVICE IDENTIFICATION

Trade or Proprietary Names:	Quantisal™ Oral Fluid Collection Device
Common Name:	Oral Fluid Collection Device

C. REGULATORY INFORMATION

Device Classification Name:	Oral Fluid Drugs Of Abuse And Alcohol Test SpecimenCollection Device
Product Codes:	PJD
Regulatory Class:	Class II
Classification Regulation:	862.1675
Panel:	Clinical Chemistry (75)
Predicate Device:	Quantisal™ II Oral Fluid Collection Device [K183048]

D. DEVICE DESCRIPTION

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, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines and tramadol. This device is for prescription use only.

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The Quantisal Oral Fluid Collection System collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer. This results in a 1 to 4 dilution factor.

Immunalysis Quantisal Oral Fluid Collection Device is sold as a stand-alone collection device.

E. INTENDED USE

For In Vitro Diagnostic Use

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, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines and tramadol.

Attribute	Predicate DeviceQuantisal II Oral Fluid CollectionDevice [K183048]	Candidate DeviceQuantisal Oral Fluid CollectionDevice
Similarities
Intended Use	Collection, preservation and transportof oral fluid specimens fortetrahydrocannabinol (THC), cocaineand its metabolite benzoylecgonine,morphine, codeine, oxycodone,hydrocodone, 6-acetylmorphine,phencyclidine, amphetamine,methamphetamine, buprenorphine,methadone, benzodiazepines andtramadol. For prescription Use only.	Identical
Material	Cellulose pad, polypropylene stem andtransport tube	Identical
Body Contact	Cellulose pad placed under the tonguefor up to 10 mins	Identical
Principle	Collecting an oral fluid specimen on acellulose pad and preserving it in abuffer solution contained in acollection tube	Identical
Sample Collection	Place cellulose pad under the tonguefor collection until blue dye visible inthe window of the stem	Identical
Transport Tube	Polypropylene tube containingpreservative buffer	Identical
Sample Matrix	Human oral fluid	Identical
Differences
Collector	Collector containing two pads. Thesetwo pads can be separated aftercollection	Collector containing one pad
Sample Volume	1 mL on each pad, 2 mL in total	1 mL

F. COMPARISON WITH PREDICATE

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Attribute	Predicate DeviceQuantisal II Oral Fluid CollectionDevice [K183048]	Candidate DeviceQuantisal Oral Fluid CollectionDevice
Qty. of TransportTube	2 transport tubes, 1 for each pad	1 transport tube

G. PERFORMANCE CHARACTERISTICS

The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Quantisal Oral Fluid Collection Devices to the predicate device. Clinical and analytical performances were established using Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and Gas chromatography-mass spectrometry (GC-MS).

1. Sample Volume

Seventy-five oral fluid samples from known drug users were collected using Quantisal collectors (collection pad with plastic stem). After the volume adequacy indicator turned blue on the collector stem, the collector was weighed and compared to the average weight of collector before collection. The difference in weight was noted. Specific gravity of saliva was rounded to 1.000 to compute the volume collection. The results confirmed consistency of sample volume of 1 mL collected by the Ouantisal collector.

2. Sample Collection Time

Seventy-five oral fluid samples from known drug users were collected using Quantisal collector (collection pad with plastic stem). The collection time was documented. The results verified the sample collection time for Quantisal Oral Fluid Collection Device is within the claimed time of 10 minutes in over 90% of subjects.

3. Drug Recovery

Drug free negative oral fluid spiked with the drug listed in Table 1 at ±25%, +50% of the cutoff were collected and stored in Quantisal Oral Fluid Collection Device overnight at room temperature. LC-MS/MS or GC-MS testing was performed the next day to determine percentage recovery. The studies demonstrated the Quantisal Collection Device recovers tested drugs at greater than 80% of the original concentration.

Drugs	TestingMethod	SAMHSA ScreeningCutoff (ng/mL)
THC	GC-MS	4
Benzoylecgonine	LC-MS/MS	15
Cocaine	LC-MS/MS	15
Morphine	LC-MS/MS	30
Codeine	LC-MS/MS	30
Oxycodone	LC-MS/MS	30

Table 1. Drug Information

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Drugs	TestingMethod	SAMHSA ScreeningCutoff (ng/mL)
Hydrocodone	LC-MS/MS	30
6-acetylmorphine	LC-MS/MS	4
Phencyclidine	LC-MS/MS	10
Amphetamine	LC-MS/MS	50
Methamphetamine	LC-MS/MS	50
Buprenorphine*	LC-MS/MS	3
Methadone*	LC-MS/MS	20
Benzodiazepines *	LC-MS/MS	5
Tramadol*	GC-MS	50

*Cutoff not established by SAMHSA. Buprenorphine cutoff is suggested by Brigham and Women's Hospital, Boston, MA. Methadone cutoff is determined by the reference article (1). Benzodiazepines and Tramadol cutoffs are determined by referencing 2013-2014 National Roadside Study of Alcohol and Drug Use by Drivers.

4. Oral Fluid Sample Extraction Efficiency and Stability

Drug free negative oral fluid spiked with drugs listed in Table 1 at +50% of the cutoff were collected and stored in Quantisal Oral Fluid Collection Device and tested by LC-MS/MS or GC/MS at each time point at 25°C during the first 24 hours post-collection to determine the point at which extraction was complete and used as a baseline for comparison for determining sample stability. The drug recovery met the minimum acceptance criterion of >80% at 4 hours post collection for all drugs and reached >90% at 24 hours for all drugs to show a complete extraction.

Sample Stability testing was performed using LC-MS/MS or GC/MS at multiple timepoints postcollection at 25°C and at 2°C - 8°C. The results are presented in Table 2.

Drugs	Stability at 8-25°C	Stability at 2-8°C
THC	10 days	2 months
Benzoylecgonine	10 days	3 months
Cocaine	5 days	1 month
Morphine	10 days	3 months
Codeine	10 days	3 months
Oxycodone	10 days	3 months
Hydrocodone	10 days	3 months
6-acetylmorphine	10 days	3 months
Phencyclidine	10 days	3 months
Amphetamine	10 days	3 months
Methamphetamine	10 days	3 months
Buprenorphine	10 days	3 months
Methadone	10 days	3 months

Table 2. Oral Fluid Sample Stability Results

1 Teresa R. Gray, Riet Dams, Robin E. Choo, Hendree E. Jones, Marilyn A. Huestis, Methadone disposition in oral fluid during pharmacotherapy for opioid-dependence, Forensic Science International 206 (2011)98-102.

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Drugs	Stability at 8-25°C	Stability at 2-8°C
Benzodiazepines	10 days	3 months
Tramadol	10 days	3 months

5. Sample Transportation Stability

Drug free negative oral fluid spiked with drugs listed in Table 1 at ±50% of the cutoff were collected and stored in Ouantisal Oral Fluid Collection Device and packed in standard boxes used by common carrier (FedEx). During the 4-day (96 hours) simulated transportation study, the samples were stored in oven/freezer at temperatures ranged from -20°C to encompass the temperatures likely to occur during shipment of products. The device used as the reference (unstressed) condition was stored continuously at the recommended storage condition at 2°C -8°C. LC-MS/MS or GC/MS testing was performed in replicates of two and compared to the reference sample. Additionally, a supplemental study was performed by testing samples collected by Quantisal device stored at three different temperature ranges for 24 hours respectively: 25°C, 40°C and 2°C-8°C. The studies demonstrated the drug concentration of the sample collected by Quantisal Oral Fluid Collection Device is within 20% of reference value during transportation.

6. Borosilicate Glass Vial Stability

Drug free expectorated oral fluid was spiked with the drug analyte at a concentration +50% of the confirmation cutoffs listed in Table 3. The initial concentration of the solution was analyzed by mass spectrometry. Three borosilicate glass vials were introduced sequentially into each aliquot, stored at 25℃ for 48 hours, and then tested using the same analytical method. The drug loss of the samples collected by borosilicate glass vial was within ±10% of the initial value after 48 hours storage at 25°C.

Drugs	TestingMethod	SAMHSA Confirmation Cutoff(ng/mL)
THC	GC-MS	2
Benzoylecgonine	LC-MS/MS	8
Cocaine	LC-MS/MS	8
Morphine	LC-MS/MS	15
Codeine	LC-MS/MS	15
Oxycodone	LC-MS/MS	15
Hydrocodone	LC-MS/MS	15
6-acetylmorphine	LC-MS/MS	2
Phencyclidine	LC-MS/MS	10 (laboratory LOQ 5 ng/mL was used)
Amphetamine	LC-MS/MS	25 (15 ng/mL was used according topreviously proposed SAMHSA cutoff)
Methamphetamine	LC-MS/MS	25 (15 ng/mL was used according topreviously proposed SAMHSA cutoff)
Buprenorphine*	LC-MS/MS	3

Table 3. Drug Information

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Drugs	TestingMethod	SAMHSA Confirmation Cutoff(ng/mL)
Methadone*	LC-MS/MS	20
Benzodiazepines*	LC-MS/MS	5
Tramadol*	GC-MS	50

*Cutoff not established by SAMHSA.

7. Expectorated Oral Fluid Samples Processed Through Quantisal (Dipping Study)

At least sixty deidentified, unaltered drug containing oral fluid samples were collected by expectoration (spitting) at clinical research facility, and analyzed using LC-MS/MS or GC/MS. A minimum of ten samples of each drug were within ±50% of the confirmation cutoffs listed in Table 3. A Quantisal device was introduced into each expectorated sample. The next day, Quantisal samples were analyzed by mass spectrometry. 899/900 paired results meet the criteria that Quantisal concentration was within ±20% of the expectorated result. This study demonstrated no difference in drug concentrations in oral fluid when expectorated samples are compared to the same oral fluid subjected to Quantisal collection regardless of drug class. The Quantisal oral fluid collection device does not introduce bias to quantitative results of expectoration neat oral fluid sample (clinical truth).

8. Drug Free Clinical Specimens

At least forty deidentified, unaltered drug free clinical oral fluid samples collected by expectoration (spitting) and Quantisal Oral Fluid Collection Devices were obtained from clinical research facility, analyzed for drug listed in Table 3 using LC-MS/MS or GC/MS. The results of all expectorated samples and Quantisal samples are negative for each drug. The study demonstrated the accuracy of the Quantisal Oral Fluid Collection Device when collecting drug free clinical specimens.

H. CONCLUSION

The information provided in this premarket notification demonstrates that the Immunalysis Quantisal Oral Fluid Collection Device is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 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.