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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a separate table or section with numerical targets. Instead, it presents performance characteristics and implies that the observed results met the requirements for substantial equivalence. The key performance indicators evaluated were precision, interference, linearity/recovery, stability, calibration duration, and method comparison.

For the purpose of this analysis, I will infer the acceptance criteria from common expectations for FDA-cleared diagnostic devices, particularly for qualitative and semi-quantitative assays, and present the reported device performance against these implicit criteria.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion (Inferred)	Reported Device Performance
Precision	Qualitative: Accurate classification (Negative/Positive) at and around the cutoff (10 ng/mL).	Qualitative:
		* Below Cutoff (-100% to -25%): 60/60 Negative (100% accuracy)
		* At Cutoff (10 ng/mL): 29 Neg / 31 Pos (indicating expected variability at the cutoff)
		* Above Cutoff (+25% to +100%): 60/60 Positive (100% accuracy)
	Semi-Quantitative: Mean concentration values close to expected, with accurate classification at and around the cutoff.	Semi-Quantitative:
		* Below Cutoff (-100% to -25%): Mean concentrations very close to expected, 60/60 Negative.
		* At Cutoff (10 ng/mL): Mean concentration 10.1 ng/mL, 30 Neg / 30 Pos.
		* Above Cutoff (+25% to +100%): Mean concentrations very close to expected, 60/60 Positive.
Specificity & Cross-Reactivity	No significant interference or false positives/negatives from structurally similar compounds or other common substances.	Data reported in K181135 (predicate device submission). Implies acceptable performance for the candidate device.
Interference (Other)	No significant interference from structurally unrelated compounds, endogenous compounds, or exogenous compounds (e.g., orally used products).	Orally Used Exogenous Compounds: No interference observed with any of the tested compounds (e.g., Teeth Whitener, Hydrogen Peroxide, Cigarette, Hard Candy, Chewing Gum, Cough Syrup) at tested concentrations, for both qualitative and semi-quantitative modes (data for Quantisal II device reported in K181135).
		Other Interferents: Data for Structurally Unrelated, Endogenous, and pH interference reported in K181135. Implies acceptable performance.
Linearity/Recovery	Recovery within an acceptable range (e.g., 80-120%) across the linear range.	Linear range confirmed to be 4-40 ng/mL. Recovery percentages ranged from 97.5% to 111.4%, indicating good recovery across the tested range. (Data for Quantisal II device reported in K181135).
PCP Stability	Oral fluid samples containing PCP remain stable for a specified period under recommended storage conditions.	Oral fluid samples containing PCP are stable for up to 12 months at 2°C - 8°C in Quantisal II Oral Fluid Collection Device. Data for 10-day storage at ambient temperature (8°C - 25°C) in Quantisal II were reported in K183048 and K200801.
Calibration Duration	Device maintains performance within acceptable limits for a specified duration between calibrations.	The recommended frequency of calibration is 14 days, as test results met acceptance criteria at each time point in a study up to 14 days. Data for qualitative mode reported in K181135.
Method Comparison	High agreement rates (e.g., usually >95% or 98%) with a confirmed analytical method (LC-MS/MS) for both positive and negative samples.	100% Agreement for both Qualitative and Semi-Quantitative modes across all observed PCP concentration ranges (Quantisal: 40/40 Positive, 40/40 Negative; Quantisal II A: 40/40 Positive, 40/40 Negative; Quantisal II B: 40/40 Positive, 40/40 Negative). This indicates excellent concordance with LC-MS/MS. This high agreement suggests the device effectively identifies PCP presence and absence relative to the gold standard.

Study Details

The provided document describes a series of laboratory performance studies to demonstrate the substantial equivalence of the SEFRIA PCP Oral Fluid Enzyme Immunoassay.

Sample size used for the test set and the data provenance:
- Precision (Quantitative Test Set): For each concentration level (0 ng/mL, 2.5 ng/mL, 5 ng/mL, 7.5 ng/mL, 10 ng/mL, 12.5 ng/mL, 15 ng/mL, 17.5 ng/mL, 20 ng/mL), there were 60 determinations.
  - Data Provenance: Drug-free negative oral fluid was "spiked" to target concentrations. This is a controlled laboratory study, not directly from human patients. The "Data for the candidate device used with Quantisal II device were reported in K181135" indicates that some results, specifically for Quantisal II, were referenced from a previous submission, suggesting a mix of new and previously generated data on the device platform.
- Interference - Orally Used Endogenous Compounds: For each compound tested (e.g., Teeth Whitener, Cigarette), samples were prepared by volunteers using the substance, then spiked with PCP at ±25% of the cutoff. The exact number of samples for each compound is not specified, but the conclusion states "No interference was observed with any of the compounds," implying sufficient testing.
  - Data Provenance: Oral fluid collected from "volunteers" after use of substances. This implies prospective collection in a controlled setting.
- Linearity/Recovery: Multiple pools were created by serial dilution. Each pool was tested in triplicate. (Number of distinct samples not explicitly stated, but 13 concentration levels were tested in triplicate for 39 total runs of the assay).
  - Data Provenance: Drug-free oral fluid pools spiked with PCP. Controlled laboratory study.
- PCP Stability in Oral Fluid: Samples spiked with PCP were stored and tested periodically. The exact number of samples per time point is not specified but referenced baseline concentration results.
  - Data Provenance: Spiked drug-free negative oral fluid. Controlled laboratory study.
- Calibration Duration: Samples spiked with PCP at ±25% of the cutoff were tested at time points up to 14 days. Exact number of samples per time point not specified.
  - Data Provenance: Spiked drug-free negative oral fluid. Controlled laboratory study.
- Method Comparison (Clinical Test Set): 80 deidentified, unaltered clinical oral fluid samples.
  - Data Provenance: Obtained from drug treatment facilities. This indicates retrospective collection from human subjects in a real-world clinical setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Precision, Interference, Linearity/Recovery, Stability, Calibration Duration: For these analytical studies, the ground truth was established by carefully controlled spiking concentrations of PCP, confirmed by mass spectrometry (LC-MS/MS) before collection (for precision) or by reference methods. This doesn't involve "experts" in the clinical sense, but rather relies on the accuracy of the laboratory's preparation and analytical techniques.
- Method Comparison: For the 80 clinical samples, the ground truth was established by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). This is a highly sensitive and specific confirmatory analytical method and acts as the gold standard, so no human experts are used for this type of ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication methods (like 2+1 or 3+1 consensus by experts) are typically used in studies involving subjective interpretation, such as imaging or pathology, where human readers create the initial "truth."
- In this context, where the ground truth is established by objective analytical methods (LC-MS/MS, or precisely prepared spiked samples), there is no human adjudication process described or needed. The analytical results are the ground truth.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not applicable to an in vitro diagnostic device like an enzyme immunoassay, which is a standalone automated analytical test. The "readers" here are the instruments and their output, not human interpreters.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance studies described are inherently "standalone." The SEFRIA PCP Oral Fluid Enzyme Immunoassay is an automated system (used with clinical analyzers like the Beckman Coulter AU480). All performance characteristics (precision, linearity, method comparison, etc.) evaluate the device's analytical output without human intervention in the interpretation of the primary result. Human intervention comes after the preliminary positive result, where confirmation by GC-MS or LC-MS/MS is required.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Primary Ground Truth: For the method comparison and for confirming spiked concentrations, the analytical gold standard was Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
- Other Ground Truths: For precision, linearity/recovery, stability, and calibration duration, the ground truth was established by precisely prepared spiked samples with known concentrations, often verified by LC-MS/MS.
The sample size for the training set:
- The document describes performance validation studies for the device, not the development or training of a machine learning model. Therefore, a "training set" in the context of AI/ML is not explicitly mentioned or relevant here. The device is an enzyme immunoassay, which operates on chemical reactions and optical detection, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- As there's no mention of a machine learning "training set," this question is not applicable. The assay's "learning" or optimization would have occurred during its internal development and formulation, not through an enumerated "training set" in the context of an FDA submission for an in vitro diagnostic immunoassay.

Summary

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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

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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

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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.

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 Corporation829 Towne Center DrivePomona, CA 91767Establishment # 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]

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D. DEVICE DESCRIPTION

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.

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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 DeviceSEFRIA PCP Oral Fluid EnzymeImmunoassay	Predicate DeviceSEFRIA PCP Oral Fluid EnzymeImmunoassay [K181135]
Similarities
Intended Use	Qualitative and semi-quantitativeanalysis of PCP in human oral fluid	Qualitative and semi-quantitativeanalysis of PCP in human oral fluid
Test Principle	Identical	Homogeneous enzymeimmunoassay
CalibratedAgainst	Identical	PCP
Assay Materials	Identical	antibody reagent, drug conjugatereagent
Cutoff Level	Identical	10 ng/mL
UserEnvironment	Identical	For use in laboratories
Sample Matrix	Identical	Human oral fluid
Reagent Storage	Identical	2-8°C until expiration date
Instrumentation	Identical	Automated clinical chemistryanalyzer
MassSpectrometryConfirmation	Identical	Required for preliminary positiveanalytical results
Differences
SampleCollectionDevice	Oral fluid is collected with theQuantisal or Quantisal II Oral FluidCollection Device. Samples arestored in plastic tubes containing	Oral fluid is collected with theQuantisal II Oral Fluid CollectionDevice. Samples are stored inplastic 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)	% ofCutoff	# ofDeterminations	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.

1. Interference Structurally Unrelated Compounds, Endogenous Compounds and Exogenous Compounds
  Data were reported in K181135.

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

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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 PCPOral Fluid EIAResult		< 5 ng/mL(less than-50%cutoff)	5 – 9 ng/mL(between -50% cutoffand cutoff)	10 – 15 ng/mL(betweencutoff and+50% cutoff)	> 15 ng/mL(greaterthan +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 PCPOral Fluid EIAResult	< 5 ng/mL(less than-50%cutoff)	5 – 9 ng/mL(between -50% cutoffand cutoff)	10 – 15 ng/mL(betweencutoff and+50% cutoff)	> 15 ng/mL(greaterthan +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)

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Quantisal II B
		LC-MS/MS PCP Neat Oral Fluid Concentration
	SEFRIA PCPOral Fluid EIAResult	< 5 ng/mL(less than-50%cutoff)	5 - 9 ng/mL(between -50% cutoffand cutoff)	10 - 15 ng/mL(betweencutoff and+50% cutoff)	> 15 ng/mL(greaterthan +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.

Regulation Number and Section

N/A