(144 days)
No
The summary describes a standard enzyme immunoassay for detecting PCP in oral fluid. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The analysis relies on chemical reactions and standard laboratory procedures.
No
This device is for In Vitro Diagnostic Use to detect PCP in oral fluid, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is explicitly stated as being "For In Vitro Diagnostic Use" and "an in vitro diagnostic test," which directly categorize it as a diagnostic device.
No
The device is an in vitro diagnostic test that utilizes an enzyme immunoassay and requires a physical oral fluid collection device (Quantisal or Quantisal II) and clinical analyzers. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
- Device Description: The "Device Description" section also explicitly states: "The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is an in vitro diagnostic test..."
- Nature of the Test: The device performs an enzyme immunoassay on human oral fluid samples to detect the presence of PCP. This is a laboratory test performed on a biological sample outside of the body, which is the definition of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use.
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 10 ng/mL in neat oral fluid collected by Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of PCP in human oral fluid with clinical analyzers. This assay is calibrated against PCP.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result. particularly when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
LCM
Device Description
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is an in vitro diagnostic test to detect the presence of PCP in human oral fluid samples collected by Quantisal or Quantisal II Oral Fluid Collection Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For use in laboratories
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)
Precision: Precision study was performed over 15 days, 2 runs per day with 2 collection devices per run (N=60), one replicate per collection device on 1 lot of reagent and 3 lots of Quantisal oral fluid collection devices. Drug free negative oral fluid was spiked to concentrations of assay cutoff and +/- 25%, +/- 50%, +/- 75%, +/- 100% of the cutoff and was collected using the collection devices. The spiked concentrations were confirmed by mass spectrometry (LC-MS/MS) before collection. The study established the repeatability of the testing system, including assay and oral fluid collection device.
Specificity and Cross-Reactivity: Data were reported in K181135.
Interference Structurally Unrelated Compounds, Endogenous Compounds and Exogenous Compounds: Data were reported in K181135.
Interference - Orally Used Endogenous Compounds: Orally used exogenous compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free oral fluid containing PCP at +/- 25% of the cutoff. The drug free oral fluid samples were collected using Quantisal Oral Fluid Collection Device from volunteers after use of the substances. No interference was observed with any of the compounds at the concentrations tested.
Interference - pH: Data were reported in K181135.
Linearity/Recovery: A linearity study in the semi-quantitative mode was conducted by spiking a drug free oral fluid pool with a high concentration of PCP above the highest calibrator. Additional pools were made by serially diluting the high concentration specimen with drug free oral fluid to achieve concentrations ranging from 4 ng/mL to 44 ng/mL. The 0 ng/mL specimen was made from drug free oral fluid. Each pool was collected by Quantisal oral fluid collection device and tested in triplicate to calculate the mean concentration values that were used to calculate drug recovery. The study confirmed the linear range to be 4-40 ng/mL.
PCP Stability in Oral Fluid: Drug free negative oral fluid spiked with PCP at +50% of the 10 ng/mL cutoff were collected and stored in Quantisal and Quantisal II Oral Fluid Collection Devices at 2 degC - 8 degC, tested by LC-MS/MS at each time point and compared to the baseline concentration results indicate that oral fluid samples containing PCP are stable for up to 12 months stored in Quantisal II Oral Fluid Collection Device at 2 degC - 8 degC. Data to support 10-day storage in Quantisal II Oral Fluid Collection Device at ambient temperature 8 degC - 25 degC were reported in K183048 and K200801.
Calibration Duration: Drug free negative oral fluid spiked with PCP at +/- 25% of the cutoff were tested in semi-quantitative at time points up to 14 days. At the initial time point, a multi-points calibration curve was established in semi-quantitative mode. These calibrations were used through the duration of the study. The test results met acceptance criteria at each timepoint. The recommended frequency of calibration is 14 days. Data for qualitative mode were reported in K181135.
Method Comparison: Eighty (80) deidentified, unaltered clinical oral fluid samples collected by Quantisal II Oral Fluid Collection Devices were obtained from drug treatment facilities, analyzed for PCP at assay cutoff with the SEFRIA PCP Oral Fluid Enzyme Immunoassay in both qualitative and semi-quantitative modes and compared to Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) results. The instruments used were the Beckman Coulter AU480 chemistry analyzer and an Agilent 6430 Liquid Chromatography/Tandem Mass Spectrometry.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision (Qualitative):
0 ng/mL: 60 Negative
2.5 ng/mL: 60 Negative
5 ng/mL: 60 Negative
7.5 ng/mL: 60 Negative
10 ng/mL: 29 Neg/31 Pos
12.5 ng/mL: 60 Positive
15 ng/mL: 60 Positive
17.5 ng/mL: 60 Positive
20 ng/mL: 60 Positive
Precision (Semi-Quantitative):
0 ng/mL: Mean Conc. -0.2, 60 Negative
2.5 ng/mL: Mean Conc. 2.3, 60 Negative
5 ng/mL: Mean Conc. 4.9, 60 Negative
7.5 ng/mL: Mean Conc. 7.3, 60 Negative
10 ng/mL: Mean Conc. 10.1, 30 Neg /30 Pos
12.5 ng/mL: Mean Conc. 13.2, 60 Positive
15 ng/mL: Mean Conc. 15.9, 60 Positive
17.5 ng/mL: Mean Conc. 18.3, 60 Positive
20 ng/mL: Mean Conc. 21.7, 60 Positive
Linearity/Recovery:
0 ng/mL: Mean Conc. 0.0, Recovery N/A
4 ng/mL: Mean Conc. 3.9, Recovery 97.5%
8 ng/mL: Mean Conc. 8.2, Recovery 102.1%
10 ng/mL: Mean Conc. 10.2, Recovery 102.3%
12 ng/mL: Mean Conc. 13.0, Recovery 108.1%
16 ng/mL: Mean Conc. 17.3, Recovery 108.3%
20 ng/mL: Mean Conc. 19.8, Recovery 98.8%
24 ng/mL: Mean Conc. 25.5, Recovery 106.1%
28 ng/mL: Mean Conc. 30.5, Recovery 108.8%
32 ng/mL: Mean Conc. 34.4, Recovery 107.4%
36 ng/mL: Mean Conc. 38.9, Recovery 108.1%
40 ng/mL: Mean Conc. 40.2, Recovery 100.6%
44 ng/mL: Mean Conc. 49.0, Recovery 111.4%
Method Comparison (Quantisal):
Qual. Positive: 0 (15 ng/mL). Agreement 100% (40/40)
Qual. Negative: 36 (15 ng/mL). Agreement 100% (40/40)
Semi-Quant. Positive: 0 (15 ng/mL). Agreement 100% (40/40)
Semi-Quant. Negative: 36 (15 ng/mL). Agreement 100% (40/40)
Method Comparison (Quantisal II A):
Qual. Positive: 0 (15 ng/mL). Agreement Not provided in table, but implicit 100% based on negative counts.
Qual. Negative: 36 (15 ng/mL). Agreement 100% (40/40)
Semi-Quant. Positive: 0 (15 ng/mL). Agreement 100% (40/40)
Semi-Quant. Negative: 36 (15 ng/mL). Agreement 100% (40/40)
Method Comparison (Quantisal II B):
Qual. Positive: 0 (15 ng/mL). Agreement 100% (40/40)
Qual. Negative: 36 (15 ng/mL). Agreement 100% (40/40)
Semi-Quant. Positive: 0 (15 ng/mL). Agreement 100% (40/40)
Semi-Quant. Negative: 36 (15 ng/mL). Agreement 100% (40/40)
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.
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay [K181135]
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.
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
N/A
0
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April 20, 2021
Elina Arroyo Manager Regulatory Affairs Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767
Re: K203489
Trade/Device Name: SEFRIA PCP Oral Fluid Enzyme Immunoassay Regulatory Class: unclassified, 510(k) required Product Code: LCM Dated: November 24, 2020 Received: November 27, 2020
Dear Elina Arroyo:
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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 medical devices and radiation-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.
Kellie B. Kelm, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K203489
Device Name SEFRIATM PCP Oral Fluid Enzyme Immunoassay
Indications for Use (Describe) For In Vitro Diagnostic Use.
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 10 ng/mL in neat oral fluid collected by Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of PCP in human oral fluid with clinical analyzers. This assay is calibrated against PCP.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result. particularly when preliminary positive results are used.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
A. GENERAL INFORMATION
| Applicant Name: | Immunalysis Corporation
829 Towne Center Drive
Pomona, CA 91767
Establishment # 2020952 |
|------------------|--------------------------------------------------------------------------------------------------|
| Company Contact: | Wenying (Jessica) Zhu |
Manager, Regulatory Affairs Phone: (909) 451-6697
November 24, 2020 Date Prepared:
B. DEVICE IDENTIFICATION
Trade or Proprietary Names: SEFRIA PCP Oral Fluid Enzyme Immunoassay
Common Name: PCP Oral Fluid Enzyme Immunoassay
C. REGULATORY INFORMATION
Device Classification Name: Enzyme Immunoassay, Phencyclidine
| Product Codes: | LCM |
|---|---|
| Regulatory Class: | Unclassified |
| Classification Regulation: | Unclassified |
| Panel: | Toxicology (91) |
| Predicate Device: | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay [K181135] |
4
D. DEVICE DESCRIPTION
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is an in vitro diagnostic test to detect the presence of PCP in human oral fluid samples collected by Quantisal or Quantisal II Oral Fluid Collection Device.
Phencyclidine (PCP) was first synthesized in 1926 and later tested after World War II as a surgical anesthetic. Because of its adverse side effects, such as hallucinations, mania, delirium, and disorientation, it was shelved until the 1950s. The drug is easily synthesized by anyone with a basic knowledge of chemistry and has become one of the drugs most frequently used by drug abusers. It has a variety of street names, including "angel dust," "animal tranquilizer," "PCP," "peace pill," "crystal joints," and "peace weed," with the name often reflecting the form in which it is taken. It can be smoked, "snorted" through the nose, ingested, or taken intravenously. Phencyclidine has also been shown to cause schizophrenia-like changes in N-acetylaspartate and N-acetylaspartylglutamate in the rat brain, which are detectable both in living rats and upon necropsy examination of brain tissue. It also induces symptoms in humans that mimic schizophrenia. Behavioral effects can vary by dosage. Low doses produce numbness in the extremities and intoxication, characterized by staggering, unsteady gait, slurred speech, bloodshot eyes, and loss of balance. Moderate doses (5-10 mg intranasal, or 0.01-0.02 mg/kg intramuscular or intravenous) will produce analgesia and anesthesia. High doses may lead to convulsions. Users frequently do not know how much of the drug they are taking due to the tendency of the drug to be made illegally in uncontrolled conditions.
E. INTENDED USE
For In Vitro Diagnostic Use.
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a homogenous enzyme immunoassay with a cutoff of 10 ng/mL in neat oral fluid collected by Quantisal™ or Quantisal™ II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of PCP in human oral fluid with clinical analyzers. This assay is calibrated against PCP.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
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The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.
F. COMPARISON WITH PREDICATE
| Attribute | Candidate Device
SEFRIA PCP Oral Fluid Enzyme
Immunoassay | Predicate Device
SEFRIA PCP Oral Fluid Enzyme
Immunoassay [K181135] |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Qualitative and semi-quantitative
analysis of PCP in human oral fluid | Qualitative and semi-quantitative
analysis of PCP in human oral fluid |
| Test Principle | Identical | Homogeneous enzyme
immunoassay |
| Calibrated
Against | Identical | PCP |
| Assay Materials | Identical | antibody reagent, drug conjugate
reagent |
| Cutoff Level | Identical | 10 ng/mL |
| User
Environment | Identical | For use in laboratories |
| Sample Matrix | Identical | Human oral fluid |
| Reagent Storage | Identical | 2-8°C until expiration date |
| Instrumentation | Identical | Automated clinical chemistry
analyzer |
| Mass
Spectrometry
Confirmation | Identical | Required for preliminary positive
analytical results |
| Differences | | |
| Sample
Collection
Device | Oral fluid is collected with the
Quantisal or Quantisal II Oral Fluid
Collection Device. Samples are
stored in plastic tubes containing | Oral fluid is collected with the
Quantisal II Oral Fluid Collection
Device. Samples are stored in
plastic tubes containing |
| | preservative buffer with snap caps. | preservative buffer with snap caps. |
The selected predicate device is Immunalysis SEFRIA PCP Enzyme Immunoassay K181135.
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IMMUNALYSIS
G. PERFORMANCE CHARACTERISTICS
The following laboratory performance studies were performed to determine substantial equivalence of the SEFRIA PCP Oral Fluid Enzyme Immunoassay to the predicate device. Assay performance was established using the Beckman Coulter AU480 chemistry analyzer.
1. Precision
Precision study was performed over 15 days, 2 runs per day with 2 collection devices per run (N=60), one replicate per collection device on 1 lot of reagent and 3 lots of Quantisal oral fluid collection devices. Drug free negative oral fluid was spiked to concentrations of assay cutoff and ±25%, ±50%, ±75%, ±100% of the cutoff and was collected using the collection devices. The spiked concentrations were confirmed by mass spectrometry (LC-MS/MS) before collection. The study established the repeatability of the testing system, including assay and oral fluid collection device. Test results in qualitative and semi-quantitative modes for a representative lot are presented in Tables 1 and 2.
Data for the candidate device used with Quantisal II device were reported in K181135.
| Concentration
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 0 | -100% | 60 | 60 Negative |
| 2.5 | -75% | 60 | 60 Negative |
| 5 | -50% | 60 | 60 Negative |
| 7.5 | -25% | 60 | 60 Negative |
| 10 | Cutoff | 60 | 29 Neg/31 Pos |
| 12.5 | +25% | 60 | 60 Positive |
| 15 | +50% | 60 | 60 Positive |
| 17.5 | +75% | 60 | 60 Positive |
| 20 | +100% | 60 | 60 Positive |
Table 1. Precision - Qualitative
| Concentration
(ng/mL) | % of
Cutoff | # of
Determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|----------------|
| 0 | -100% | 60 | -0.2 | 60 Negative |
| 2.5 | -75% | 60 | 2.3 | 60 Negative |
| 5 | -50% | 60 | 4.9 | 60 Negative |
| 7.5 | -25% | 60 | 7.3 | 60 Negative |
| 10 | Cutoff | 60 | 10.1 | 30 Neg /30 Pos |
Table 2. Precision - Semi-Quantitative
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| 12.5 | 25% | 60 | 13.2 | 60 Positive |
|---|---|---|---|---|
| 15 | 50% | 60 | 15.9 | 60 Positive |
| 17.5 | 75% | 60 | 18.3 | 60 Positive |
| 20 | 100% | 60 | 21.7 | 60 Positive |
2. Specificity and Cross-Reactivity
Data were reported in K181135.
-
- Interference Structurally Unrelated Compounds, Endogenous Compounds and Exogenous Compounds
Data were reported in K181135.
- Interference Structurally Unrelated Compounds, Endogenous Compounds and Exogenous Compounds
4. Interference - Orally Used Endogenous Compounds
Orally used exogenous compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free oral fluid containing PCP at ±25% of the cutoff. The drug free oral fluid samples were collected using Quantisal Oral Fluid Collection Device from volunteers after use of the substances. Orally used compounds tested are presented in Table 3. No interference was observed with any of the compounds at the concentrations tested.
Data for the candidate device used with Quantisal II device were reported in K181135.
| Compound | Concentration Tested |
|---|---|
| Teeth Whitener | 2 strips |
| Hydrogen Peroxide (3% OTC) | Neat (2 min mouth rinse) |
| Cigarette | 1 cigarette |
| Hard Candy | 1 piece |
| Chewing Gum | 1 piece |
| Cough Syrup | 2 Teaspoons |
Table 3. Non-interfering Orally Used Exogenous Products
5. Interference - pH
Data were reported in K181135.
6. Linearity/Recovery
A linearity study in the semi-quantitative mode was conducted by spiking a drug free oral fluid pool
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with a high concentration of PCP above the highest calibrator. Additional pools were made by serially diluting the high concentration specimen with drug free oral fluid to achieve concentrations ranging from 4 ng/mL to 44 ng/mL. The 0 ng/mL specimen was made from drug free oral fluid. Each pool was collected by Quantisal oral fluid collection device and tested in triplicate to calculate the mean concentration values that were used to calculate drug recovery. Linearity test results in semi-quantitative mode are presented in Tables 4. The study confirmed the linear range to be 4-40 ng/mL.
Data for the candidate device used with Quantisal II device were reported in K181135.
| Expected Concentration | Mean Concentration | Recovery (%) |
|---|---|---|
| (ng/mL) | (ng/mL) | |
| 0 | 0.0 | N/A |
| 4 | 3.9 | 97.5 |
| 8 | 8.2 | 102.1 |
| 10 | 10.2 | 102.3 |
| 12 | 13.0 | 108.1 |
| 16 | 17.3 | 108.3 |
| 20 | 19.8 | 98.8 |
| 24 | 25.5 | 106.1 |
| 28 | 30.5 | 108.8 |
| 32 | 34.4 | 107.4 |
| 36 | 38.9 | 108.1 |
| 40 | 40.2 | 100.6 |
| 44 | 49.0 | 111.4 |
Table 4. Linearity/Recovery
7. PCP Stability in Oral Fluid
Drug free negative oral fluid spiked with PCP at +50% of the 10 ng/mL cutoff were collected and stored in Quantisal and Quantisal II Oral Fluid Collection Devices at 2°C - 8°C, tested by LC-MS/MS at each time point and compared to the baseline concentration results indicate that oral fluid samples containing PCP are stable for up to 12 months stored in Quantisal II Oral Fluid Collection Device at 2°C - 8°C.
Data to support 10-day storage in Quantisal II Oral Fluid Collection Device at ambient temperature 8°C - 25°C were reported in K183048 and K200801.
8. Calibration Duration
Drug free negative oral fluid spiked with PCP at ±25% of the cutoff were tested in semi-quantitative at
9
IMMUNALYSIS
time points up to 14 days. At the initial time point, a multi-points calibration curve was established in semi-quantitative mode. These calibrations were used through the duration of the study. The test results met acceptance criteria at each timepoint. The recommended frequency of calibration is 14 days.
Data for qualitative mode were reported in K181135.
9. Method Comparison
Eighty (80) deidentified, unaltered clinical oral fluid samples collected by Quantisal II Oral Fluid Collection Devices were obtained from drug treatment facilities, analyzed for PCP at assay cutoff with the SEFRIA PCP Oral Fluid Enzyme Immunoassay in both qualitative and semi-quantitative modes and compared to Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) results. The instruments used were the Beckman Coulter AU480 chemistry analyzer and an Agilent 6430 Liquid Chromatography/Tandem Mass Spectrometry. Method comparison test results in qualitative and semiquantitative modes are presented from Tables 5 to 7.
| Quantisal | ||||||
|---|---|---|---|---|---|---|
| LC-MS/MS PCP Neat Oral Fluid Concentration | ||||||
| SEFRIA PCP | ||||||
| Oral Fluid EIA | ||||||
| Result | 15 ng/mL | |||||
| (greater | ||||||
| than +50% | ||||||
| cutoff) | Agreement (%) | |||||
| Positive | 0 | 0 | 7 | 33 | 100% (40/40) | |
| Qual. | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi- | Positive | 0 | 0 | 7 | 33 | 100% (40/40) |
| Quant. | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
Table 5. Method Comparison
Table 6. Method Comparison
| Quantisal II A | |||||
|---|---|---|---|---|---|
| LC-MS/MS PCP Neat Oral Fluid Concentration | |||||
| SEFRIA PCP | |||||
| Oral Fluid EIA | |||||
| Result | 15 ng/mL | ||||
| (greater | |||||
| than +50% | |||||
| cutoff) | Agreement (%) | ||||
| Qual. | |||||
| Positive | 0 | 0 | 4 | 36 | |
| Qual. | |||||
| Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi- | |||||
| Quant. | |||||
| Positive | 0 | 0 | 4 | 36 | 100% (40/40) |
| Semi- | |||||
| Quant. | |||||
| Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
10
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| Quantisal II B | ||||||
|---|---|---|---|---|---|---|
| LC-MS/MS PCP Neat Oral Fluid Concentration | ||||||
| SEFRIA PCP | ||||||
| Oral Fluid EIA | ||||||
| Result | 15 ng/mL | |||||
| (greater | ||||||
| than +50% | ||||||
| cutoff) | Agreement (%) | |||||
| Qual. | Positive | 0 | 0 | 6 | 34 | 100% (40/40) |
| Qual. | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi- | ||||||
| Quant. | Positive | 0 | 0 | 6 | 34 | 100% (40/40) |
| Semi- | ||||||
| Quant. | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
Table 7. Method Comparison
H. CONCLUSION
The information provided in this pre-market notification demonstrates that the Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its intended use.