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K Number
K152176
Device Name
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
Manufacturer
Immunalysis Corporation
Date Cleared
2015-09-04

(31 days)

Product Code
LCM
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Immunalysis PCP Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 25ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of PCP in human urine with automated clinical chemistry 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 permitting laboratories to establish quality control procedures. The Immunalysis PCP Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and PCP. The calibrators are designed for prescription use with immunoassays.
Device Description
1. The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes recombinant antibodies to Phencyclidine. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes phencyclidine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. 2. All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture. The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles. The concentration of drug analyte in the corresponding calibrators are summarized as follows: Table 1 Immunalysis Multi-Drug Calibrators Analyte, Multi-Drug Calibrators, Level 1, Level 2, Level 3, Level 4 Benzoylecgonine, 150ng/mL, 300ng/mL, 500ng/mL, 1000ng/mL Morphine, 100ng/mL, 300ng/mL, 500ng/mL, 1000ng/mL PCP, 12.5ng/mL, 25ng/mL, 50ng/mL, 100ng/mL
More Information

K935320, K051088

Not Found

No
The device is a homogeneous enzyme immunoassay kit and calibrators, which are chemical reagents used with automated clinical chemistry analyzers. The description focuses on the chemical components and performance characteristics of the assay, with no mention of AI or ML algorithms for data analysis or interpretation.

No.
The device is an in-vitro diagnostic test intended for qualitative and semi-quantitative analysis of PCP in human urine, used in laboratories for diagnostic purposes, not for treating diseases or conditions.

Yes
The 'Intended Use / Indications for Use' section explicitly states, "This in-vitro diagnostic device is for prescription use only," and describes its use for the analysis of PCP in human urine for preliminary analytical test results.

No

The device description clearly outlines physical components including reagents and calibrators, indicating it is not a software-only device.

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."
  • Intended Use: The device is intended for the qualitative and semi-quantitative analysis of PCP in human urine, which is a biological sample. This analysis is performed in vitro (outside the body).
  • Laboratory Use: The assay is intended for use in laboratories, which is a typical setting for IVD testing.
  • Calibration: The device uses calibrators (Immunalysis Multi-Drug Calibrators) which are also explicitly stated as being for "in vitro diagnostic use for the calibration of assays".
  • Regulatory Context: The mention of "prescription use only" and the inclusion of predicate devices (K numbers) strongly indicate that this device is subject to regulatory oversight as an IVD.

N/A

Intended Use / Indications for Use

The Immunalysis PCP Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 25ng/mL. The assay is intended for use in laboratories for the qualitative analysis of PCP in human urine with automated clinical chemistry analyzers. This assay is callibrated 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 permitting laboratories to establish quality control procedures.

The Immunalysis PCP Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and PCP. The calibrators are designed for prescription use with immunoassays.

Product codes (comma separated list FDA assigned to the subject device)

LCM, DKB

Device Description

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. 1. The antibody/ substrate reagent includes recombinant antibodies to Phencyclidine. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes phencyclidine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
2. All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture. The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles. The concentration of drug analyte in the corresponding calibrators are summarized as follows:

Table 1 Immunalysis Multi-Drug Calibrators
Analyte | Multi-Drug Calibrators
| Level 1 | Level 2 | Level 3 | Level 4
Benzoylecgonine | 150ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL
Morphine | 100ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL
PCP | 12.5ng/mL | 25ng/mL | 50ng/mL | 100ng/mL

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

laboratories, prescription use only

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

Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed with the test device.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

  1. Precision/Cutoff Characterization Study: Performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75%, and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result.

    • Qualitative Analysis (25ng/mL cutoff):
      • 0 ng/mL (-100% cutoff): 80 determinations, 80 Negative
      • 6.25 ng/mL (-75% cutoff): 80 determinations, 80 Negative
      • 12.5 ng/mL (-50% cutoff): 80 determinations, 80 Negative
      • 19 ng/mL (-25% cutoff): 80 determinations, 80 Negative
      • 25 ng/mL (Cutoff): 80 determinations, 35 Negative/45 Positive
      • 31 ng/mL (+25% cutoff): 80 determinations, 80 Positive
      • 37.5 ng/mL (+50% cutoff): 80 determinations, 80 Positive
      • 43.75 ng/mL (+75% cutoff): 80 determinations, 80 Positive
      • 50 ng/mL (+100% cutoff): 80 determinations, 80 Positive
    • Semi-Quantitative Analysis (25ng/mL cutoff):
      • 0 ng/mL (-100% cutoff): 80 determinations, 80 Negative
      • 6.25 ng/mL (-75% cutoff): 80 determinations, 80 Negative
      • 12.5 ng/mL (-50% cutoff): 80 determinations, 80 Negative
      • 19 ng/mL (-25% cutoff): 80 determinations, 80 Negative
      • 25 ng/mL (Cutoff): 80 determinations, 30 Negative/50 Positive
      • 31 ng/mL (+25% cutoff): 80 determinations, 80 Positive
      • 37.5 ng/mL (+50% cutoff): 80 determinations, 80 Positive
      • 43.75 ng/mL (+75% cutoff): 80 determinations, 80 Positive
      • 50 ng/mL (+100% cutoff): 80 determinations, 80 Positive

  2. Specificity and Cross-Reactivity Study: Structurally similar compounds were spiked into drug free urine 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.

  3. Interference Study: Structurally non-similar compounds, endogenous compounds, the effect of pH, the effect of specific gravity and boric acid was evaluated by spiking the potential interferent into drug free urine containing the target analyte at ±25% of the cutoff. All potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds or an internally existing physiological condition. Boric Acid interferes with the assay and the limitations have been added to the labeling regarding this compound.

  4. Linearity/Recovery Study: A drug free urine pool was spiked with high concentration of the target analyte as a high value specimen. Additional pools were made by serially diluting the high value specimen.

    • Recovery (%): Ranged from 94.7% (10 ng/mL expected) to 111.9% (70 ng/mL expected).

  5. Method Comparison Study: Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed with the test device. The study verified that the product performance can be verified by Mass Spectrometry.

    • Qualitative Assay Performance (25ng/mL cutoff) vs. LC/MS Confirmation:
      • Test Device (+), LC/MS (+): 40
      • Test Device (+), LC/MS (-): 0
      • Test Device (-), LC/MS (+): 0
      • Test Device (-), LC/MS (-): 40
    • Assay Performance verified by LC/MS – 25ng/mL Cutoff:
      • Qualitative/Positive: Agreement 100%
      • Qualitative/Negative: Agreement 100%
    • Semi-Quantitative Assay Performance (25ng/mL cutoff) vs. LC/MS Confirmation:
      • Test Device (+), LC/MS (+): 40
      • Test Device (+), LC/MS (-): 0
      • Test Device (-), LC/MS (+): 0
      • Test Device (-), LC/MS (-): 40
    • Semi-Quantitative Assay Performance verified by LC/MS – 25ng/mL Cutoff:
      • Semi-Quantitative/Positive: Agreement 100%
      • Semi-Quantitative/Negative: Agreement 100%

  6. Calibrator and Control Analytical Performance - Immunalysis Multi-Drug Calibrators:

    • Traceability: All components traced to a commercially available PCP solution.
    • Closed Vial Stability: Supported an initial expiration date of 12 months at 25℃. All calibrator levels (1, 2, 3, and 4) for PCP were within specifications for Day 0, 8, 16, 24, 32, and 40. Real time stability studies are ongoing.
    • Open Vial Stability: Supported an initial open vial expiration date of 60 days at 5℃. All calibrator levels (1, 2, 3, and 4) for PCP were within specifications for Day 0, 19, 26, 33, 41, and 60.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not directly stated as Sensitivity, Specificity, PPV, NPV. However, for Method Comparison:
Qualitative/Positive Agreement (%): 100
Qualitative/Negative Agreement (%): 100
Semi-Quantitative/Positive Agreement (%): 100
Semi-Quantitative/Negative Agreement (%): 100

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.

K935320, K051088

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.

Not Found

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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DRIVE POMONA CA 91767

September 4, 2015

Re: K152176

Trade/Device Name: Immunalysis PCP Urine Enzyme Immunoassay and Immunalysis Multi-Drug Calibrators Regulation Number: 21 CFR 862.3100 Regulatory Class: Unclassified Product Code: LCM. DKB Dated: August 3, 2015 Received: August 4, 2015

Dear Joseph Ginete:

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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -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

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Indications for Use

510(k) Number (if known)K152176

Device Name

Immunalysis PCP Urine Enzyme Immunoassay and Immunalysis Multi-Drug Calibrators

Indications for Use (Describe)

The Immunalysis PCP Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 25ng/mL. The assay is intended for use in laboratories for the qualitative analysis of PCP in human urine with automated clinical chemistry analyzers. This assay is callbrated 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 permitting laboratories to establish quality control procedures.

The Immunalysis PCP Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and PCP. The calibrators are designed for prescription use with immunoassays.

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

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

  • A. Contact Information
1.Manufacturer:Immunalysis Corporation
2.Contact Name:Joseph Ginete
3.Contact Title:Regulatory Affairs Specialist II
4.Address:829 Towne Center Drive Pomona, CA 91767
5.Phone:(909) 482-0840
6.Fax:(909) 482-0850
7.Email:jginete@immunalysis.com
8.Summary prepared on:September 3, 2015
B. Device Information
1.Trade Name:Immunalysis PCP Urine Enzyme Immunoassay
Immunalysis Multi-Drug Calibrators
2.Common Name:Immunalysis PCP Urine Enzyme Immunoassay
Immunalysis Multi-Drug Calibrators
C. Regulatory Information
1.510(k) Number:K152176
2.Device Classification:Unclassified
3.Regulation Section:Enzyme Immunoassay, Phencyclidine
CFR 862.3200 Clinical Toxicology Calibrator
4.Panel:Toxicology(91)
5.Product Code:LCM
DKB

D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))

| 1. Predicate Device: | DRI Phencyclidines Assay
LZI Multiple Analyte Drugs of Abuse Calibrators
and Controls |
|------------------------|---------------------------------------------------------------------------------------------|
| 2. Predicate Company: | Diagnostic Reagents Inc.
Lin-Zhi International, Inc. |
| 3. Predicate K Number: | K935320
K051088 |

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  • E. Device Description
    • The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. 1. The antibody/ substrate reagent includes recombinant antibodies to Phencyclidine. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes phencyclidine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
      1. All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture. The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles. The concentration of drug analyte in the corresponding calibrators are summarized as follows:
Table 1 Immunalysis Multi-Drug Calibrators
AnalyteMulti-Drug Calibrators
Level 1Level 2Level 3Level 4
Benzoylecgonine150ng/mL300ng/mL500ng/mL1000ng/mL
Morphine100ng/mL300ng/mL500ng/mL1000ng/mL
PCP12.5ng/mL25ng/mL50ng/mL100ng/mL
  • F. Intended Use
      1. Immunalysis PCP Urine Enzyme Immunoassay

The Immunalysis PCP Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 25ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of PCP in human urine with automated clinical chemistry 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 permitting laboratories to establish quality control procedures.

The Immunalysis PCP Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

    1. Immunalysis Multi-Drug Calibrators
      The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and PCP. The calibrators are designed for prescription use with immunoassays.

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  • G. Comparison of the new device with the predicate device
ItemPCP Assay K935320Immunalysis PCP Urine EIA
Intended UseFor the qualitative and semi-
quantitative determination of the
presence of PCP in human urine at a
cutoff of 25ng/mLSame
Type of ProductAnalytical ReagentsSame
Measured AnalytesPCPSame
Test MatrixUrineSame
Cutoff Levels25ng/mL of PCPSame
Test SystemHomogeneous Enzyme ImmunoassaySame
MaterialsLiquid Ready-to-Use Two Reagent
Assay (R1 and R2)Antibody/Substrate Reagents and
Enzyme Labeled Conjugate
Mass Spectroscopy
ConfirmationRequired for preliminary positive
analytical resultsSame
AntibodyMonoclonal antibodies to PCPRecombinant antibody to PCP
Storage2 - 8°C until expiration dateSame
ItemLZI Multiple Analyte K051088Immunalysis Multi-Drug Calibrators
Analytebenzoylecgonine, d-
methamphetamine, methadone,
morphine, oxazepam, secobarbital,
phencyclidine, propoxyphenebenzoylecgonine, morphine,
phencyclidine
MatrixUrineSame
Calibrator Levels5 Levels – See Table 2 Below4 Levels (Negative and Level 1, 2, 3 and
    • See Device Description Table 1 |
      | Storage | 2 – 8°C until expiration date | Same |

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  • H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Phencyclidine Enzyme Immunoassay to the predicate
      1. Precision/Cutoff Characterization Study was performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75%, and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. The instruments used for this was Beckman Coulter AU 400e.

a. The following is a summary table of the Qualitative Analysis for the 25ng/mL cutoff test data results

Table 3 - Qualitative Analysis (for 25ng/mL cutoff)
Concentration
(ng/mL)% of
cutoff# of
determinationsResult
0-100%8080 Negative
6.25-75%8080 Negative
12.5-50%8080 Negative
19-25%8080 Negative
25Cutoff8035 Negative/45 Positive
31+25%8080 Positive
37.5+50%8080 Positive
43.75+75%8080 Positive
50+100%8080 Positive

b. The following is a summary table of the Semi-Quantitative Analysis for the 25ng/mL cutoff test data results

Table 4 - Semi-Quantitative Analysis (for 25ng/mL cutoff)
Concentration
(ng/mL)% of cutoff# of
determinationsResult
0-100%8080 Negative
6.25-75%8080 Negative
12.5-50%8080 Negative
19-25%8080 Negative
25Cutoff8030 Negative/50 Positive
31+25%8080 Positive
37.5+50%8080 Positive
43.75+75%8080 Positive
50+100%8080 Positive

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IMMUNALYSIS

    1. Specificity and Cross-Reactivity Structurally similar compounds were spiked into drug free urine 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. The instrument used for this test was a Beckman Coulter AU 400e.
a. The qualitative result summary table for the 25ng/mL cutoff is outlined
below:
Table 5 - Structurally Related Compounds (for 25 ng/mL cutoff) - Qualitative
CompoundConcentration Tested (ng/mL)ResultCross-Reactivity (%)
PCP25Positive100
Chlorpromazine140,000Positive0.01785
Clomipramine350,000Positive0.00714
Cyclobenzaprine25,000Positive0.10000
Dextromethorphan80,000Positive0.03125
Diphenhydramine220,000Positive0.01136
Doxepin90,000Positive0.02777
4 – Hydroxyphencyclidine3,500Positive0.71429
Imipramine200,000Positive0.01250
Methoxetamine36,000Positive0.06944
Thioridazine140,000Positive0.01785
Venlafaxine1,000,000Positive0.00250

b. The semi-quantitative result summary table for the 25ng/mL cutoff is outlined below:

Table 6 - Structurally Related Compounds (for 25ng/mL cutoff) – Semi-Quantitative
CompoundConcentration Tested (ng/mL)Mean ValueCross-Reactivity (%)
PCP2526.7100
Chlorpromazine140,00025.90.01785
Clomipramine350,00024.80.00714
Cyclobenzaprine25,00024.90.10000
Dextromethorphan80,00024.10.03125
Diphenhydramine220,00026.60.01136
Doxepin90,00027.10.02777
4 – Hydroxyphencyclidine3,50025.60.71429
Imipramine200,00026.40.01250
Methoxetamine36,00025.90.06944
Thioridazine140,00025.40.01785
Venlafaxine1,000,00023.90.00250
    1. Interference Structurally non-similar compounds, endogenous compounds, the effect of pH, the effect of specific gravity and boric acid was evaluated by spiking the potential interferent into drug free urine containing the target analyte at ±25% of the cutoff. All potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds or an internally existing physiological condition. The instrument used for this test was a Beckman Coulter AU 400e.

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Table 7 - Structurally Non-Similar Compounds (for 25ng/mL cutoff)
Concentration-25% Cutoff (19ng/mL)+25% Cutoff (31ng/mL)
CompoundTested
(ng/mL)ResultInterference?ResultInterference?
Acetaminophen500000NegativeNoPositiveNo
6-Acetylcodeine100000NegativeNoPositiveNo
6-Acetylmorphine100000NegativeNoPositiveNo
Acetylsalicylic Acid500000NegativeNoPositiveNo
Alprazolam100000NegativeNoPositiveNo
7-Aminoclonazepam100000NegativeNoPositiveNo
7-Aminoflurnitrazepam100000NegativeNoPositiveNo
7-Aminonitrazepam100000NegativeNoPositiveNo
Amitriptyline70000NegativeNoPositiveNo
Amobarbital100000NegativeNoPositiveNo
S-(+)-Amphetamine100000NegativeNoPositiveNo
Benzylpiperzine100000NegativeNoPositiveNo
Bromazepam100000NegativeNoPositiveNo
4-bromo 2-5,
dimethoxyphenethylamine100000NegativeNoPositiveNo
Buprenorphine100000NegativeNoPositiveNo
Bupropion100000NegativeNoPositiveNo
Butabarbital100000NegativeNoPositiveNo
Butalbital100000NegativeNoPositiveNo
Caffeine500000NegativeNoPositiveNo
Cannabidiol100000NegativeNoPositiveNo
Cannabinol100000NegativeNoPositiveNo
Carbamazepine100000NegativeNoPositiveNo
Carisoprodol100000NegativeNoPositiveNo
Chlordiazepoxide100000NegativeNoPositiveNo
cis-Tramadol100000NegativeNoPositiveNo
Clobazam100000NegativeNoPositiveNo
Clonazepam100000NegativeNoPositiveNo
Clozapine100000NegativeNoPositiveNo
Codeine100000NegativeNoPositiveNo
Cotinine100000NegativeNoPositiveNo
Demoxepam100000NegativeNoPositiveNo
Desalkyflurazepam100000NegativeNoPositiveNo
Desipramine100000NegativeNoPositiveNo
Diazepam100000NegativeNoPositiveNo
Digoxin100000NegativeNoPositiveNo
Dihydrocodeine100000NegativeNoPositiveNo
Dehydronorketamine100000NegativeNoPositiveNo
$\Delta^9$THC100000NegativeNoPositiveNo
Table 7 - Structurally Non-Similar Compounds (for 25ng/mL cutoff)
CompoundConcentration
Tested
(ng/mL)-25% Cutoff (19ng/mL)
Result-25% Cutoff (19ng/mL)
Interference?+25% Cutoff (31ng/mL)
Result+25% Cutoff (31ng/mL)
Interference?
EDDP100000NegativeNoPositiveNo
EDMP100000NegativeNoPositiveNo
1R,2S Ephedrine100000NegativeNoPositiveNo
1S,2R Ephedrine100000NegativeNoPositiveNo
Ethyl-ẞ-D-Glucuronide100000NegativeNoPositiveNo
Ethylmorphine100000NegativeNoPositiveNo
Fenfluramine100000NegativeNoPositiveNo
Fentanyl100000NegativeNoPositiveNo
Flunitrazepam100000NegativeNoPositiveNo
Fluoxetine100000NegativeNoPositiveNo
Flurazepam100000NegativeNoPositiveNo
Haloperidol100000NegativeNoPositiveNo
Heroin100000NegativeNoPositiveNo
Hexobarbital100000NegativeNoPositiveNo
Hydrocodone100000NegativeNoPositiveNo
Hydromorphone100000NegativeNoPositiveNo
11-hydroxy-△' THC100000NegativeNoPositiveNo
Ibuprofen500000NegativeNoPositiveNo
Ketamine100000NegativeNoPositiveNo
Lamotrigine100000NegativeNoPositiveNo
Levorphanol Tartrate100000NegativeNoPositiveNo
Lidocaine100000NegativeNoPositiveNo
Lorazepam100000NegativeNoPositiveNo
Lorazepam Glucuronide50000NegativeNoPositiveNo
Lormetazepam100000NegativeNoPositiveNo
LSD100000NegativeNoPositiveNo
Maprotiline100000NegativeNoPositiveNo
MDA100000NegativeNoPositiveNo
MDEA100000NegativeNoPositiveNo
MDMA100000NegativeNoPositiveNo
Meperidine100000NegativeNoPositiveNo
Meprobamate100000NegativeNoPositiveNo
Methadone100000NegativeNoPositiveNo
Methylphenidate100000NegativeNoPositiveNo
R(-)-Methamphetamine100000NegativeNoPositiveNo
S(+)-Methamphetamine100000NegativeNoPositiveNo
Methaquolone100000NegativeNoPositiveNo
Methylone100000NegativeNoPositiveNo
Midazolam100000NegativeNoPositiveNo
Morphine100000NegativeNoPositiveNo
Morphine-3- ẞ-Glucuronide100000NegativeNoPositiveNo
Morphine-6ẞ-D-Glucuronide50000NegativeNoPositiveNo
Table 7 - Structurally Non-Similar Compounds (for 25ng/mL cutoff)
CompoundConcentration
Tested
(ng/mL)-25% Cutoff (19ng/mL)
Result-25% Cutoff (19ng/mL)
Interference?+25% Cutoff (31ng/mL)
Result+25% Cutoff (31ng/mL)
Interference?
N-Desmethyltapentadol100000NegativeNoPositiveNo
Nalorphine100000NegativeNoPositiveNo
Naloxone100000NegativeNoPositiveNo
Naltrexone100000NegativeNoPositiveNo
Naproxen100000NegativeNoPositiveNo
Nitrazepam100000NegativeNoPositiveNo
11-nor-9-carboxy-Δ9-THC100000NegativeNoPositiveNo
Norbuprenorphine50000NegativeNoPositiveNo
Norcodeine100000NegativeNoPositiveNo
Nordiazepam100000NegativeNoPositiveNo
Norketamine100000NegativeNoPositiveNo
Normorphine100000NegativeNoPositiveNo
Norproxyphene100000NegativeNoPositiveNo
Norpseudoephedrine100000NegativeNoPositiveNo
Nortriptyline100000NegativeNoPositiveNo
Olanzapine100000NegativeNoPositiveNo
Oxazepam100000NegativeNoPositiveNo
Oxycodone100000NegativeNoPositiveNo
Oxymorphone100000NegativeNoPositiveNo
Pentazocine100000NegativeNoPositiveNo
Pentobarbital100000NegativeNoPositiveNo
Phenobarbital100000NegativeNoPositiveNo
Phentermine100000NegativeNoPositiveNo
Phenylephrine100000NegativeNoPositiveNo
Phenylpropanolamine100000NegativeNoPositiveNo
Phenytoin100000NegativeNoPositiveNo
PMA100000NegativeNoPositiveNo
Prazepam100000NegativeNoPositiveNo
Propoxyphene100000NegativeNoPositiveNo
Propranolol100000NegativeNoPositiveNo
Protripyline100000NegativeNoPositiveNo
R,R Pseudoephedrine100000NegativeNoPositiveNo
S,S Pseudoephedrine100000NegativeNoPositiveNo
Ranitidine100000NegativeNoPositiveNo
Ritalinic Acid100000NegativeNoPositiveNo
Salicylic Acid100000NegativeNoPositiveNo
Secobarbital100000NegativeNoPositiveNo
Sertraline100000NegativeNoPositiveNo
Sufentanil Citrate50000NegativeNoPositiveNo
Tapentadol100000NegativeNoPositiveNo
Temazepam100000NegativeNoPositiveNo
Theophylline100000NegativeNoPositiveNo
Table 7 - Structurally Non-Similar Compounds (for 25ng/mL cutoff)
CompoundConcentration
Tested
(ng/mL)-25% Cutoff (19ng/mL)
Result-25% Cutoff (19ng/mL)
Interference?+25% Cutoff (31ng/mL)
Result+25% Cutoff (31ng/mL)
Interference?
Triazolam100000NegativeNoPositiveNo
Trifluoromethylphenyl-
piperazine100000NegativeNoPositiveNo
Trimipramine100000NegativeNoPositiveNo
Verapamil60000NegativeNoPositiveNo
Zolpidem Tartrate100000NegativeNoPositiveNo

a. The following is a table of the structurally non-similar compounds for the 25ng/mL cutoff

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b.The following is a table of the endogenous compounds results for the 25ng/mL cutoff

Table 8 - Endogenous Compounds (for 25ng/mL cutoff)
CompoundConcentration Tested (ng/mL)-25% Cutoff (19ng/mL) ResultInterference?+25% Cutoff (31ng/mL) ResultInterference?
Acetone1.0 g/dLNegativeNoPositiveNo
Ascorbic Acid1.5 g/dLNegativeNoPositiveNo
Bilirubin0.002 g/dLNegativeNoPositiveNo
Creatinine0.5 g/dLNegativeNoPositiveNo
Ethanol1.0 g/dLNegativeNoPositiveNo
Galactose0.01 g/dLNegativeNoPositiveNo
y-Globulin0.5 g/dLNegativeNoPositiveNo
Glucose2.0 g/dLNegativeNoPositiveNo
Hemoglobin0.115 g/dLNegativeNoPositiveNo
Human Serum Albumin0.5 g/dLNegativeNoPositiveNo
Oxalic Acid0.1 g/dLNegativeNoPositiveNo
Riboflavin0.0075 g/dLNegativeNoPositiveNo
Sodium Azide1% w/vNegativeNoPositiveNo
Sodium Chloride6.0 g/dLNegativeNoPositiveNo
Sodium Fluoride1% w/vNegativeNoPositiveNo
Urea6.0 g/dLNegativeNoPositiveNo
c. The following is a table of the boric acid for the 25ng/mL cutoff results
Table 9 - Boric Acid (for 25ng/mL cutoff)
CompoundConcentration Tested (ng/mL)-25% Cutoff (19ng/mL) ResultInterference?+25% Cutoff (31ng/mL) ResultInterference?
Boric Acid1% w/vNEGNoNEGYes
d.The following is a table of the boric acid for the 25ng/mL cutoff results
Table 10 - Boric Acid (for 25ng/mL cutoff)
CompoundConcentration Tested-50% Cutoff (13ng/mL) ResultInterference?+50% Cutoff (38ng/mL) ResultInterference?

(ng/mL) 1% w/v

Yes NEG e. Boric Acid interferes with the assay and the limitations have been added to the labeling regarding this compound

No

NEG

Boric Acid

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Table 11 - Effect of pH (for 25ng/mL cutoff)
Test ParameterValue-25% Cutoff (19ng/mL)+25% Cutoff (31ng/mL)
ResultInterference?ResultInterference?
pH3.0NegativeNoPositiveNo
pH4.0NegativeNoPositiveNo
pH5.0NegativeNoPositiveNo
pH6.0NegativeNoPositiveNo
pH7.0NegativeNoPositiveNo
pH8.0NegativeNoPositiveNo
pH9.0NegativeNoPositiveNo
pH10.0NegativeNoPositiveNo
pH11.0NegativeNoPositiveNo

f. The following is a table of the effect of pH results for the 25ng/mL cutoff

g.The following is a summary table of the effect of specific gravity results for the 25ng/mL cutoff

Table 12 - Effect of Specific Gravity (for 25ng/mL cutoff)
Test ParameterValue-25% Cutoff (19ng/mL)+25% Cutoff (31ng/mL)
ResultInterference?ResultInterference?
Specific Gravity1.000NegativeNoPositiveNo
Specific Gravity1.002NegativeNoPositiveNo
Specific Gravity1.005NegativeNoPositiveNo
Specific Gravity1.010NegativeNoPositiveNo
Specific Gravity1.015NegativeNoPositiveNo
Specific Gravity1.020NegativeNoPositiveNo
Specific Gravity1.025NegativeNoPositiveNo
Specific Gravity1.030NegativeNoPositiveNo
    1. Linearity/ Recovery A drug free urine pool was spiked with high concentration of the target analyte as a high value specimen. Additional pools were made by serially diluting the high value specimen. The instrument used for this test was a Beckman Coulter AU 400e.
      a.The following is a summary table of the linearity/recovery:
Table 13 - Linearity/ Recovery
Expected Concentration (ng/mL)Mean Concentration (ng/mL)Recovery (%)
109.594.7
2019.698.2
2527.0108.1
3032.4108.0
4042.2105.6
5052.4104.9
6064.6107.6
7078.3111.9
8085.4106.8
9094.6105.1

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Table 13 - Linearity/ Recovery
Expected Concentration (ng/mL)Mean Concentration (ng/mL)Recovery (%)
100100.8100.8
110110.0100.0
    1. Method Comparison Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed with the test device. The study verified that the product performance can be verified by Mass Spectrometry. The instrument used for this test was a Beckman Coulter AU 400e and an Agilent 6430 Liquid Chromatography Tandem Mass Spectrometry.
    • a. The following is a comparison table of qualitative assay performance for the 25ng/mL cutoff:
    • Table 14 Method Comparison for the 25ng/mL Qualitative
LC/MS Confirmation
(+)(-)
Test
Device(+)400
(-)040

b. The following is a summary table of the qualitative assay performance for the 25ng/mL cutoff

Table 15 - Assay Performance verified by LC/MS – 25ng/mL Cutoff
TypePCP ConcentrationAgreement (%)
37.5 ng/mL
Qualitative/ Positive00634100
Qualitative/ Negative36400100

c. The following is a comparison table of semi-quantitative assay performance for the 25ng/mL cutoff

Table 16 - Method Comparison for the 25ng/mL - Semi-Quantitative

LC/MS Confirmation
(+)(-)
Test(+)400
Device(-)040

d.The following is a summary table of semi-quantitative assay performance for the 25ng/mL cutoff

Table 16 - Assay Performance verified by LC/MS – 25ng/mL Cutoff
Type37.5 ng/mLAgreement (%)
Semi-Quantitative/ Positive00634100
Semi-Quantitative / Negative36400100
  1. Calibrator and Control Analytical Performance - Immunalysis Multi-Drug Calibrators

a. Immunalysis Multi-Drug Calibrators Traceability - all components of the calibrators and controls have been traced to a commercially available PCP solution.

b.Immunalysis Multi-Drug Calibrators Closed Vial Stability – A closed vial stability study was performed at 25℃ to establish the initial vial expiration

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IMMUNALYSIS

dating. The stability study supported an initial expiration date of 12 months. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) for PCP were within specifications for Day 0, 8, 16, 24, 32, and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.

  • a. Immunalysi Multi-Drug Calibrators Open Vial Stability An open vial stability study was performed at 5℃ to establish the initial open vial expiration dating. The stability study supported an initial open vial expiration date of 60 days. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) for PCP were within specifications for Day 0, 19, 26, 33, 41, and 60. This stability study was performed to establish initial expiration dating.
  • b.Immunalysis Multi-Drug Calibrators Value Assignment Calibrators are manufactured and are tested by mass spectrometry. If any of the analytes are not of the acceptable range, then the calibrator is adjusted and retested. Values are assigned to the calibrators once the mass spectrometry results are within the acceptable ranges.
  • I. Conclusion

The information provided in this pre-market notification demonstrates that the Immunalysis PCP Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.