(269 days)
No
The summary describes a standard enzyme immunoassay and collection device, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic device intended for qualitative and semi-quantitative analysis of PCP in human oral fluid, not for treating or preventing disease.
Yes
The text explicitly states: "This in vitro diagnostic device is for prescription use only." and "The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a sensitive in vitro diagnostic test to detect the presence of PCP in human oral fluid samples".
No
The device is an in vitro diagnostic test that includes a physical collection device (Quantisal II Oral Fluid Collection Device) and reagents for an enzyme immunoassay, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic device is for prescription use only."
- Device Description: The "Device Description" section also refers to it as a "sensitive in vitro diagnostic test".
- Intended Use: The intended use is for the qualitative and semi-quantitative analysis of PCP in human oral fluid, which is a biological specimen. This type of analysis performed on biological samples outside of the body is the definition of an in vitro diagnostic.
- Performance Studies: The document details various performance studies (Precision, Specificity, Interference, Linearity, Stability, etc.) which are typical requirements for demonstrating the analytical performance of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K122703) indicates that this device is being compared to a previously cleared IVD by a regulatory body like the FDA.
N/A
Intended Use / Indications for Use
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 10 ng/mL in neat oral fluid collected with the 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. This in vitro diagnostic device is for prescription use only.
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
LCM
Device Description
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a sensitive in vitro diagnostic test to detect the presence of PCP in human oral fluid samples collected with the Quantisal II Oral Fluid Collection Device.
Quantisal II Oral Fluid Collection Device is a collection system comprised of a dual pad collector and transport vials. The dual pad collector is separated after collection of oral fluid from a subject's mouth enabling each specimen-saturated collection pad to be placed into its own transport vial. The split specimen (referred to as "A" and "B") allows for one sample to be tested in a screening assay and confirmed by a quantitative laboratory method (such as liquid chromatography tandem mass spectrometry [LC-MS/MS] and the second sample to be stored for secondary confirmation if needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human oral fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
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 specimen was made from drug free oral fluid. Each pool was collected using Quantisal II oral fluid collection devices and tested in triplicate to calculate the mean concentration values that were used to calculate drug recovery.
Eighty 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 Immunalysis 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 with neat oral fluid collected by expectoration (spitting). The instruments used were the Beckman Coulter AU480 chemistry analyzer and an Agilent 6430 Liquid Chromatography-Tandem Mass Spectrometry.
Precision/ Cutoff Characterization study was performed over 15 days, two collection device runs per day with two collections per run (N=60) on three lots of Quantisal II oral fluid collection devices. Drug free negative urine was spiked to concentrations of assay cutoff and ±25%, ±50%, ±75%, ±100% of the cutoff and transferred to the collection devices. The spiked concentrations were confirmed by mass spectrometry (LC-MS/MS).
Fifty oral fluid samples were collected using Quantisal II collectors (collection pad with plastic stem) from fifty volunteers. Prior to collection, each collector (A and B) was weighed. After the volume adequacy indicator turned blue on both A and B collector stems, each collector was weighed again. The difference in weight was noted. Specific gravity of saliva was rounded to 1.000 to compute the volume collection.
Additional seventy-five oral fluid samples from known drug users were collected using Quantisal II collector. After the volume adequacy indicator turned blue on both A and B collector stems, each 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.
Fifty oral fluid samples from volunteers and seventy-five oral fluid samples from known drug users were collected using Quantisal II collection pad with plastic stem). The collection time was documented.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision/Cutoff Characterization
Study Type: Precision/Cutoff Characterization
Sample Size: N=60 for each of three lots of Quantisal II oral fluid collection devices.
Key Results: The study established the repeatability of the testing system, including assay and oral fluid collection device. At the cutoff concentration (10 ng/mL), for Quantisal II "A" Qualitative mode, there were 29 Negative / 31 Positive results; for Semi-Quantitative, 28 Neg / 32 Pos. For Quantisal II "B" Qualitative mode, there were 32 Neg / 28 Pos; for Semi-Quantitative, 29 Neg / 31 Pos. At concentrations below cutoff, all results were negative; at concentrations above cutoff, all results were positive.
Specificity and Cross-Reactivity
Study Type: Specificity and Cross-Reactivity
Key Results: Structurally and functionally similar compounds were spiked into drug free oral fluid. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs. Various compounds showed cross-reactivity at different percentages, e.g., Amitriptyline (0.05%), Chlorpromazine (0.19%), 4-Hydroxyphencyclidine (11.76%). Many compounds showed 15 ng/mL. For concentrations between 10-15 ng/mL, the qualitative and semi-quantitative results were 5 positive, and for 5-9 ng/mL, they were 4 negative.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Agreements, positive/negative counts are reported, but not summarized as sensitivity/specificity).
Predicate Device(s)
RapidFRET Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and RapidEase Oral Fluid Collector [K122703]
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 24, 2019
Immunalysis Corporation Michelle Bodien Associate Director, Regulatory Affairs 829 Towne Center Drive Pomona, CA 91767
Re: K181135
Trade/Device Name: Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay Regulatory Class: Unclassified, 510(k) required Product Code: LCM Dated: December 13, 2018 Received: December 14, 2018
Dear Michelle Bodien:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181135
Device Name
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
Indications for Use (Describe)
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 10 ng/mL in neat oral fluid collected with the 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. This in vitro diagnostic device is for prescription use only.
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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K181135
A. GENERAL INFORMATION
| Applicant Name: | Immunalysis Corporation
829 Towne Center Drive
Pomona, CA 91767
Establishment # 2020952 |
|------------------|-------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Michelle Bodien
Assoc. Director, Regulatory Affairs
Phone: (210)4058453
Email: michelle.bodien@alere.com |
| Date Prepared: | January 22, 2019 |
B. DEVICE IDENTIFICATION
| Trade or Proprietary Names: | Immunalysis SEFRIA™ PCP Oral Fluid Enzyme Immunoassay |
|---|---|
| ----------------------------- | ------------------------------------------------------- |
C. REGULATORY INFORMATION
| Device Classification Name: | Enzyme Immunoassay, Phencyclidine |
|---|---|
| Product Codes: | LCM |
| Regulatory Class: | Class II |
| Classification Regulation: | Unclassified |
| Panel: | Toxicology (91) |
| Predicate Device: | RapidFRET Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and RapidEase Oral Fluid Collector [K122703] |
D. DEVICE DESCRIPTION
The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a sensitive in vitro diagnostic test to detect the presence of PCP in human oral fluid samples collected with the Quantisal II Oral Fluid Collection Device.
Quantisal II Oral Fluid Collection Device is a collection system comprised of a dual pad collector and transport vials. The dual pad collector is separated after collection of oral fluid from a subject's mouth enabling each specimen-saturated collection pad to be placed into its own transport vial. The split specimen (referred to as "A" and "B") allows for one sample to be tested in a screening assay and confirmed by a quantitative laboratory method (such as liquid chromatography tandem mass spectrometry [LC-MS/MS] and the second sample to be stored for secondary confirmation if needed.
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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 Nacetylaspartate and Nacetylaspartylglutamate 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
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
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 with the 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. This in vitro diagnostic device is for prescription use only.
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.
| Attribute | Predicate Device
RapidFRET Oral Fluid Assay
for PCP [K122703] | Candidate Device
Immunalysis SEFRIA PCP
Oral Fluid Enzyme
Immunoassay |
|----------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Similarities | | |
| Test Principle | Homogeneous enzyme
immunoassay | Same |
| Antibody | Antibodies to PCP | Same |
F. COMPARISON WITH PREDICATE
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| Attribute | Predicate Device
RapidFRET Oral Fluid Assay
for PCP [K122703] | Candidate Device
Immunalysis SEFRIA PCP
Oral Fluid Enzyme
Immunoassay |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | PCP specific antibody reagent,
PCP drug conjugate reagent | Same |
| Cutoff Level | 10 ng/mL | Same |
| User Environment | For use in laboratories | Same |
| Sample Matrix | Human oral fluid | Same |
| Reagent Storage | 2-8°C until expiration date | Same |
| | Differences | |
| Intended Use | Qualitative determination of
phencyclidine in human oral
fluid | Qualitative and semi-
quantitative determination of
phencyclidine in human oral
fluid. |
| Sample Collection Device | Neat oral fluid is collected with
the RapidEASE Oral Fluid
Collector via direct
expectoration. No diluent is used
and sample is stored in a glass
sample tube with inert screw
cap. | Oral fluid is collected with the
Quantisal II Oral Fluid
Collection Device. Sample is
stored in a plastic tube
containing preservative buffer
with snap cap. |
G. PERFORMANCE CHARACTERISTICS
The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay and Quantisal II Oral Fluid Collection Devices to the predicate device. Assay performance was established using the Beckman Coulter AU480 chemistry analyzer.
1. Precision/ Cutoff Characterization
Precision/ Cutoff Characterization study was performed over 15 days, two collection device runs per day with two collections per run (N=60) on three lots of Quantisal II oral fluid collection devices. Drug free negative urine was spiked to concentrations of assay cutoff and ±25%, ±50%, ±75%, ±100% of the cutoff and transferred to the collection devices. The spiked concentrations were confirmed by mass spectrometry (LC-MS/MS). 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 to 6.
| Concentration
(ng/mL) | % of cutoff | # of
determinations | Result |
|--------------------------|-------------|------------------------|-------------|
| 0 | -100% | 60 | 60 Negative |
Table 1. Precision - Quantisal II "A" - Qualitative
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| Concentration
(ng/mL) | % of cutoff | # of
determinations | Result |
|--------------------------|-------------|------------------------|----------------|
| 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 2. Precision – Quantisal II "A" - Semi-Quantitative
| Concentration
(ng/mL) | % of cutoff | # of
determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|-------------|------------------------|-----------------------|-----------------|
| 0 | -100% | 60 | 0.5 | 60 Negative |
| 2.5 | -75% | 60 | 2.7 | 60 Negative |
| 5 | -50% | 60 | 5.5 | 60 Negative |
| 7.5 | -25% | 60 | 7.8 | 60 Negative |
| 10 | Cutoff | 60 | 10.1 | 28 Neg / 32 Pos |
| 12.5 | 25% | 60 | 12.5 | 60 Positive |
| 15 | 50% | 60 | 15.5 | 60 Positive |
| 17.5 | 75% | 60 | 17.4 | 60 Positive |
| 20 | 100% | 60 | 20.2 | 60 Positive |
Table 3. Precision – Quantisal II "B" - Qualitative
| 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 | 32 Neg /28 Pos |
| 12.5 | 25% | 60 | 60 Positive |
| 15 | 50% | 60 | 60 Positive |
| 17.5 | 75% | 60 | 60 Positive |
| 20 | 100% | 60 | 60 Positive |
Table 4. Precision – Quantisal II "B" - Semi-Quantitative
| Concentration
(ng/mL) | % of cutoff | # of
determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|-------------|------------------------|-----------------------|-------------|
| 0 | -100% | 60 | 0.5 | 60 Negative |
| 2.5 | -75% | 60 | 2.7 | 60 Negative |
| 5 | -50% | 60 | 5.5 | 60 Negative |
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| Concentration
(ng/mL) | % of cutoff | # of
determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|-------------|------------------------|-----------------------|-----------------|
| 7.5 | -25% | 60 | 8.0 | 60 Negative |
| 10 | Cutoff | 60 | 10.1 | 29 Neg / 31 Pos |
| 12.5 | 25% | 60 | 12.7 | 60 Positive |
| 15 | 50% | 60 | 15.5 | 60 Positive |
| 17.5 | 75% | 60 | 17.5 | 60 Positive |
| 20 | 100% | 60 | 20.2 | 60 Positive |
2. Specificity and Cross-Reactivity
Structurally and functionally similar compounds were spiked into drug free oral fluid at levels that will yield a result that is equivalent to the cutoff. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs, in both the qualitative and semi-quantitative modes. Cross-reactivity test results for qualitative and semi-quantitative modes are presented in Table 7.
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| Compound | Compound
Conc.
(ng/mL) | PCP
Equivalent
Conc.
(ng/mL) | Result | Cross-
Reactivity
(%) |
|----------------------------------|------------------------------|---------------------------------------|--------|-----------------------------|
| Amitriptyline | 22,000 | 10 | POS | 0.05 |
| Chlorpromazine | 5,200 | 10 | POS | 0.19 |
| Clomipramine | 22,000 | 10 | POS | 0.05 |
| Cyclobenzaprine | 1,900 | 10 | POS | 0.53 |
| Desipramine | 40,000 | 15 ng/mL
(greater
than +50%
cutoff) | |
| Qual. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
| Semi-
Quant. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| | Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
Table 12. Method Comparison - Quantisal II "A"
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| Immunalysis SEFRIA
PCP Oral Fluid
Enzyme Immunoassay
| Result | LC-MS/MS PCP Neat Oral Fluid Concentration | |||||
|---|---|---|---|---|---|---|
| 15 ng/mL | ||||||
| (greater | ||||||
| than +50% | ||||||
| cutoff) | Agreement | |||||
| (%) | ||||||
| Qual. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| Negative | 36 | 4 | 0 | 0 | 100% (40/40) | |
| Semi- | ||||||
| Quant. | Positive | 0 | 0 | 5 | 35 | 100% (40/40) |
| Negative | 36 | 4 | 0 | 0 | 100% (40/40) |
H. CONCLUSION
The information provided in this pre-market notification demonstrates that the Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay and Immunalysis Quantisal II Oral Fluid Collection Device are substantially equivalent to the legally marketed predicate device for their intended uses.