Who is the manufacturer of Atellica CH Phencyclidine (Pcp)?

Siemens Healthcare Diagnostics, Inc. filed the 510(k) submission for Atellica CH Phencyclidine (Pcp) (K163220).

What is the FDA product code for Atellica CH Phencyclidine (Pcp)?

LCM. as a Class U device in the TX panel.

What is the regulatory pathway for Atellica CH Phencyclidine (Pcp)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Atellica CH Phencyclidine (Pcp)?

URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE (k000462).

Who can help prepare an FDA 510(k) submission like Atellica CH Phencyclidine (Pcp)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Atellica CH Phencyclidine (Pcp)

K163220 · Siemens Healthcare Diagnostics, Inc. · LCM · Apr 6, 2017 · TX

Device Facts

Record ID	K163220
Device Name	Atellica CH Phencyclidine (Pcp)
Applicant	Siemens Healthcare Diagnostics, Inc.
Product Code	LCM · TX
Decision Date	Apr 6, 2017
Decision	SESE
Submission Type	Traditional
Device Class	Class U

Intended Use

The Atellica™ CH Phencyclidine (Pcp) assay is for in vitro diagnostic use in the qualitative or semiquantitative analyses of phencyclidine in human urine using the Atellica CH Analyzer, using a cutoff of 25 ng/mL. The Pcp assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. 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 Spectrometty (GC-MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Device Story

Atellica CH Phencyclidine (Pcp) assay is a homogenous enzyme immunoassay; utilizes competition between drug in urine specimen and drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. G6PDH activity inversely proportional to drug concentration; active enzyme converts NAD+ to NADH, measured spectrophotometrically at 340/410 nm. Used on Atellica CH Analyzer in clinical laboratories. Provides preliminary qualitative or semiquantitative results; requires confirmatory testing via GC/MS or LC-MS/MS. Assists clinicians in identifying phencyclidine use or overdose; results require professional judgment.

Clinical Evidence

Bench testing only. Precision determined per CLSI EP05-A3 (N=80 per concentration). Method comparison against GC/MS reference method showed 98% positive agreement and 95% negative agreement. Interference testing per CLSI EP07-A2 confirmed assay robustness against endogenous compounds, pH, and specific gravity; boric acid identified as causing false negatives.

Technological Characteristics

Enzyme immunoassay; uses polyclonal antibody reactive to phencyclidine and phencyclidine labeled with G6PDH. Spectrophotometric detection at 340/410 nm. Reagent stable for 30 days on-system. Calibration frequency 60 days. Matrix: human urine. Cutoff: 25 ng/mL.

Indications for Use

Indicated for qualitative or semiquantitative detection of phencyclidine in human urine at a 25 ng/mL cutoff. Intended for use as a preliminary analytical test; requires confirmation by GC/MS or LC-MS/MS. For professional use in clinical laboratories.

Predicate Devices

URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE (k000462)

Related Devices

K020254 — PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 · Lin-Zhi International, Inc. · May 10, 2002
K013096 — PHENCYCLIDINE · Abbott Laboratories · Mar 13, 2002
K062094 — VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V · Ortho-Clinical Diagnostics, Inc. · Nov 22, 2006
K993983 — SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL · Syva Co. · Jan 27, 2000
K033866 — CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) · Lin-Zhi International, Inc. · Apr 7, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle are three stylized human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 6, 2017 SIEMENS HEALTHCARE DIAGNOSTICS, INC. LAURA J. DUGGAN, Ph.D., RAC REGULATORY TECHNICAL SPECIALIST 500 GBC DRIVE, PO BOX 6101 MS 514 NEWARK DE 19711 Re: k163220 Trade/Device Name: Atellica CH Phencvclidine (Pcp) Regulation Number: Unclassified Regulation Name: Enzyme Immunoassay. Phencyclidine Regulatory Class: Unclassified, 510(k) required Product Code: LCM Dated: February 14, 2017 Received: February 15, 2017 Dear Dr. Laura Duggan: 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. Courtney H. Lias -S 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) k163220 Device Name Atellica CH Phencyclidine (Pcp) #### Indications for Use (Describe) The Atellica™ CH Phencyclidine (Pcp) assay is for in vitro diagnostic use in the qualitative or semiquantitative analyses of phencyclidine in human urine using the Atellica CH Analyzer, using a cutoff of 25 ng/mL. The Pcp assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (OC/MS) is the preferred confirmatory method. 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 Spectrometty (GC-MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 10. 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. # ASSIGNED 510(K) NUMBER The assigned 510(k) number is k163220. #### APPLICANT AND DATE Laura J. Duggan, Ph. D., RAC Siemens Healthcare Diagnostics Inc. 500 GBC Drive, M/S 514 Newark, DE 19714-6101 Email: laura.j.duggan@siemens.com Phone: 302-631-7654 Fax: 302-631-6299 March 10, 2017 #### MANUFACTURER Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown, NY 10591 Registration Number: 2432235 # REGULATORY INFORMATION #### Requlatory Submission for the Atellica™ CH Phencyclidine (Pcp) | Common Name: | enzyme immunoassay, phencyclidine | |----------------------|-------------------------------------------------------------------------| | Proprietary Name: | Atellica CH Phencyclidine (Pcp) | | Classification Name: | Enzyme Immunoassay, Phencyclidine | | Regulation Number: | Unclassified | | Classification: | Unclassified, 510(k) required | | Product Code: | LCM | | Panel: | Toxicology | | Predicate Device: | URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE (k000462) | {4}------------------------------------------------ ## ATELLICA CH PHENCYCLIDINE (PCP) The Atellica CH Pcp assay is a homogenous enzyme immunoassay based on competition between drug in the specimen and drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. G6PDH activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD+) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically at 340/410 nm. Image /page/4/Figure/3 description: The image shows two reaction equations. The first equation shows Ab + PCP + PCP-G6PDH reacting to form Ab-PCP + Ab-PCP-G6PDH (inhibited) + PCP-G6PDH (active). The second equation shows Glucose-6-Phosphate + NAD+ reacting with PCP-G6PDH (active) to form 6-phosphogluconolactone + NADH + H+ (340/410 nm). The image also defines Ab as an antibody reactive to phencyclidine, PCP as phencyclidine, and PCP-G6PDH as phencyclidine conjugated to recombinant glucose-6-phosphate dehydrogenase. Urine is the only specimen type. The reagent is stored unopened at 2 - 8 °C and is stable for use on system for 30 days. Calibration is performed every 60 days for a reagent lot or every 19 days for an individual pack. # INTENDED USE/INDICATIONS FOR USE #### ATELLICA CH PHENCYCLIDINE (PCP) The Atellica™ CH Phencyclidine (Pcp) assay is for in vitro diagnostic use in the qualitative or semiquantitative analyses of phencyclidine in human urine using the Atellica CH Analyzer, using a cutoff of 25 ng/mL. The Pcp assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. 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. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result. particularly when preliminary positive results are used. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS {5}------------------------------------------------ Below is a features comparison for the Atellica CH Phencyclidine (Pcp) assay and the predicate device: | Feature | Predicate Device: URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE (k000462) | New Device: Atellica CH Phencyclidine (Pcp) | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use : | The Urine Phencyclidine Screen Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi- quantitative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. The PCP method 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) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. | The Atellica™ CH Phencyclidine (Pcp) assay is for in vitro diagnostic use in the qualitative or semiquantitative analyses of phencyclidine in human urine using the Atellica™ CH Analyzer. The Pcp assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. 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 (LCMS/MS) or permitting laboratories to establish quality control procedures. Clinical consideration and professional judgment should be applied to any drug-of- abuse test result, particularly when preliminary positive results are used. | {6}------------------------------------------------ | Type of Product: | Analytical Reagents | Same | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Measured Analyte: | PCP | Same | | Test Matrix: | Urine | Same | | Device Technology: | Enzyme Immunoassay | Same | | Materials: | Matched lots of polyclonal antibody reactive to phencyclidine and phencyclidine labeled with glucose-6-phosphate dehydrogenase are used in this Syva® Emit® II Plus methodology. | Same | | Cutoff Levels: | 25 ng/mL PCP | Same | | Confirmatory Method: | Gas Chromatography/mass spectrometry | Same | | Calibration Frequency: | 30 days | 60 days | # SUMMARY OF PERFORMANCE TESTING Assay performance comparison results for the Atellica CH Phencyclidine (Pcp) were obtained by processing the appropriate body fluids. Summary statistics for each are provided. These data demonstrate substantial equivalency of the Atellica CH Phencyclidine (Pcp) compared to the predicate device. The following data represent typical assay performance. # PRECISION/CUTOFF CHARACTERIZATION {7}------------------------------------------------ Precision was determined according to the CLSI Document EP05-A3. The study was performed for 20 days, 2 runs per day with 2 replicates (N=80) on concentrations 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. - a) The following is summary table of the Qualitative Analysis for the 25 ng/mL cutoff test data results. | Qualitative Analysis (25 ng/mL cutoff) | | | | | | |----------------------------------------|-------------|-------------------|---------------------------|--|--| | [Urine Pool] (ng/mL) | % of Cutoff | # of Results | Result | | | | 0 | -100 | 80 Negative 80 | | | | | 6.25 | -75 | 80 | 80 Negative | | | | 12.5 | -50 | 80 | 80 Negative | | | | 18.75 | -25 | 80 | 80 Negative | | | | 25 | Cutoff | 80 | 60 Positive / 20 Negative | | | | 31.25 | 25 | 80 | 80 Positive | | | | 37.5 | 50 | 80 | 80 Positive | | | | 43.75 | 75 | 80 | 80 Positive | | | | 50 | 100 | 80 80 Positive | | | | - b) The following is summary table of the semi-quantitative analysis for the 25 ng/mL cutoff test data results. | Semi-quantitative Analysis (25 ng/mL cutoff) | | | | | | | | | | |----------------------------------------------|-------------|--------------|--------------|---------------|--------|------------|--------|---------------------------|---------------------------| | Urine Pool (ng/mL) | % of Cutoff | # of Results | Mean (ng/mL) | Repeatability | | Within-Lab | | Repeatability Results | Within-Laboratory Results | | | | | | SD (ng/mL) | CV (%) | SD (ng/mL) | CV (%) | | | | 0 | -100 | 80 | 0 | 0 | N/A | 1 | N/A | 80 Negative | 80 Negative | | 6.25 | -75 | 80 | 7 | 0 | 3.8 | 1 | 7.7 | 80 Negative | 80 Negative | | 12.5 | -50 | 80 | 12 | 0 | 2.2 | 0 | 4.0 | 80 Negative | 80 Negative | | 18.75 | -25 | 80 | 18 | 0 | 1.8 | 1 | 3.3 | 80 Negative | 80 Negative | | 25 | Cutoff | 80 | 25 | 0 | 1.6 | 1 | 3.4 | 60 Positive / 20 Negative | 60 Positive / 20 Negative | | 31.25 | 25 | 80 | 30 | 1 | 2.2 | 1 | 2.7 | 80 Positive | 80 Positive | | 37.5 | 50 | 80 | 37 | 1 | 1.4 | 1 | 3.3 | 80 Positive | 80 Positive | | 43.75 | 75 | 80 | 43 | 1 | 1.5 | 2 | 4.6 | 80 Positive | 80 Positive | | 50 | 100 | 80 | 51 | 1 | 1.3 | 2 | 4.5 | 80 Positive | 80 Positive | {8}------------------------------------------------ # RECOVERY STUDY A drug free urine pool was spiked with high concentration PCP analyte stock to various target values. | Sample ID | Spiked Pcp (ng/mL) | Mean Pcp (ng/mL) | % Recovery | |-----------|--------------------|------------------|------------| | 1 | 4.0 | 4.3 | 107.5 | | 2 | 5.0 | 5.6 | 112.0 | | 3 | 10.0 | 10.1 | 101.0 | | 4 | 15.0 | 15.0 | 100.0 | | 5 | 20.0 | 19.7 | 98.5 | | 6 | 25.0 | 25.1 | 100.4 | | 7 | 30.0 | 30.0 | 100.0 | | 8 | 40.0 | 41.0 | 102.5 | | 9 | 60.0 | 60.9 | 101.5 | | 10 | 80.0 | 83.7 | 104.6 | # METHOD COMPARISON Anonymous, discarded clinical urine samples were analyzed with the test device. Method Comparison was tested by comparison to the reference method, which is GC/ MS. Six samples were prepared by pooling two native urine samples to span the assay measuring interval. All of the remaining samples were unaltered native samples. {9}------------------------------------------------ # a) Summary of Qualitative Results | | | GC/MS | | |----------|-----|-------|-----| | | (+) | (+) | (-) | | | (+) | 53 | 1 | | Atellica | (-) | 3 | 55 | # b) Summary of the Qualitative Assay Performance for the 25 ng/mL cutoff | | GC/MS Results | | | | | |--------------|------------------|-------------------------------------------------|-------------------------------------------------|------------------|-------------| | Atellica | Neg (< 13 ng/mL) | Neg Within 50% below the cutoff (13 - 24 ng/mL) | Pos Within 50% above the cutoff (25 - 38 ng/mL) | Pos (> 38 ng/mL) | % Agreement | | Qualitative | | | | | | | Atellica Pos | 0 | 1 | 17 | 36 | 98% | | Atellica Neg | 48 | 7 | 3 | 0 | 95% | # c) Summary of Semi-Quantitative Results | | | GC/MS | | |----------|-----|-------|-----| | | | (+) | (-) | | | (+) | 53 | 1 | | Atellica | (-) | 3 | 55 | # d) Summary of the Semi-Quantitative Assay Performance for the 25 ng/mL cutoff · . . | | GC/MS Results | | | | | | | |-------------------|------------------|-------------------------------------------------|-------------------------------------------------|------------------|-------------|--|--| | Atellica | Neg (< 13 ng/mL) | Neg Within 50% below the cutoff (13 - 24 ng/mL) | Pos Within 50% above the cutoff (25 - 38 ng/mL) | Pos (> 38 ng/mL) | % Agreement | | | | Semi-Quantitative | | | | | | | | | Atellica Pos | 0 | 1 | 17 | 36 | 98% | | | | Atellica Neg | 48 | 7 | 3 | 0 | 95% | | | - e) Summary of Discordant Results | Sample ID | Atellica CH (ng/mL) | GC/MS (ng/mL) | Atellica CH vs. GC/MS (POS/NEG) | |-----------|---------------------|---------------|---------------------------------| | 53 | 25 | 23.7 | +/- | {10}------------------------------------------------ | 57 | 23 | 25.3 | -/+ | |---------------|----|------|-----| | 59 | 23 | 28.2 | -/+ | | 61 | 22 | 30.0 | -/+ | | INTERFERENCES | | | | Interference was determined in accordance with CLSI Document EP07-A2. Structurally non-similar compounds, endogenous compounds, the effect of pH, the effect of specific gravity and boric acid were 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 the assay performance is unaffected by externally ingested compounds or an internally existing physiological conditions. Any test compound that was shown to produce a false response at the test concentration optionally underwent does-response testing until a false response was not obtained. | pH Value | -25% Cutoff (19 ng/mL) | | +25% Cutoff (31 ng/mL) | | |----------|------------------------|----------------|------------------------|----------------| | | Result | Intereference? | Result | Intereference? | | 3.1 | Negative | No | Positive | No | | 4.0 | Negative | No | Positive | No | | 5.0 | Negative | No | Positive | No | | 6.0 | Negative | No | Positive | No | | 7.0 | Negative | No | Positive | No | | 8.0 | Negative | No | Positive | No | | 9.0 | Negative | No | Positive | No | | 10.1 | Negative | No | Positive | No | | 11.0 | Negative | No | Positive | No | # a) Summary of the Effect of pH {11}------------------------------------------------ - b) Summary of the Effect of Specific Gravity | ടG | -25% Cutoff Pool Result (19 ng/mL) | Intereference? | +25% Cutoff Pool Result (31 ng/mL) | Intereference? | |-------|------------------------------------------|----------------|------------------------------------------|----------------| | 1.000 | Negative | No | Positive | No | | 1.002 | Negative | No | Positive | No | | 1.005 | Negative | No | Positive | No | | 1.010 | Negative | No | Positive | No | | 1.015 | Negative | No | Positive | No | | 1.020 | Negative | No | Positive | No | | 1.025 | Negative | No | Positive | No | | 1.030 | Negative | No | Positive | No | - c) Summary of the Effect of Endogenous Compounds At the stated concentration, the sample did not give a false response relative to the 25 ng/mL cutoff. | Compound | Concentration Tested | -25% of Cutoff (19 ng/mL) | +25% of Cutoff (31 ng/mL) | |-----------------------------------------------------------------|---------------------------------|---------------------------------|---------------------------------| | Acetone | 1.0 g/dL | Negative | Positive | | Ascorbic Acid | 0.75 g/dL | Negative | Positive | | Conjugated bilirubin | 0.25 mg/dL | Negative | Positive | | Creatinine | 0.5 g/dL | Negative | Positive | | Ethanol | 1.0 g/dL | Negative | Positive | | Gamma Globulin | 0.5 g/dL | Negative | Positive | | Galactose | 0.01 g/dL | Negative | Positive | | Glucose | 2.0 g/dL | Negative | Positive | | Hemoglobin | 115 mg/dL | Negative | Positive | | Human Serum Albumin | 0.5 g/dL | Negative | Positive | | Oxalic Acid | 0.1 g/dL | Negative | Positive | | Riboflavin | 7.5 mg/dL | Negative | Positive | | Sodium Azide | 1% (w/v) | Negative | Positive | | Sodium Chloride | 1.5 g/dL | Negative | Positive | | Sodium Fluoride | 1% (w/v) | Negative | Positive | | Urea | 6.0 g/dL | Negative | Positive | | | Concentration Tested | -25% of Cutoff | +25% of Cutoff | | Compound | (ng/mL) | (19 ng/mL) | (31 ng/mL) | | Acetaminophen | 500,000 | Negative | Positive | | I-a-Acetylmethadol (LAAM) | 25,000 | Negative | Positive | | N-Acetyl procainamide (NAPA) | 100,000 | Negative | Positive | | Acetylsalicylic Acid | 500,000 | Negative | Positive | | Amitriptyline | 8,750 | Negative | Positive | | S-(+)-Amphetamine | 100,000 | Negative | Positive | | Benzoylecgonine | 100,000 | Negative | Positive | | Buprenorphine | 100,000 | Negative | Positive | | Caffeine | 500,000 | Negative | Positive | | Cannabinol | 100,000 | Negative | Positive | | Carbamazepine | 100,000 | Negative | Positive | | Chlordiazepoxide | 100,000 | Negative | Positive | | Cimetidine | 100,000 | Negative | Positive | | Clonidine | 100,000 | Negative | Positive | | Codeine | 25,000 | Negative | Positive | | Cotinine | 100,000 | Negative | Positive | | Desipramine | 75,000 | Negative | Positive | | Dextrorphan | 781 | Negative | Positive | | Diazepam | 100,000 | Negative | Positive | | Digoxin | 100,000 | Negative | Positive | | 2-Ethylidene-1,5-dimethyl- 3,3-diphenylpyrrolidine (EDDP) | 12,500 | Negative | Positive | | EMDP | 100,000 | Negative | Positive | | 1R,2S-Ephedrine | 100,000 | Negative | Positive | | 1S,2R-Ephedrine | 100,000 | Negative | Positive | | Fluoxetine | 75,000 | Negative | Positive | | Flurazepam | 50,000 | Negative | Positive | | Glutethimide | 100,000 | Negative | Positive | | Haloperidol | 100,000 | Negative | Positive | | Heroin | 25,000 | Negative | Positive | | Hydrocodone | 25,000 | Negative | Positive | | Ibuprofen | 500,000 | Negative | Positive | | Ketamine | 75,000 | Negative | Positive | | Ketorolac Tromethamine | 100,000 | Negative | Positive | | Lidocaine | 100,000 | Negative | Positive | | Lorazepam | 100,000 | Negative | Positive | | Lormetazepam | 100,000 | Negative | Positive | | LSD | 100,000 | Negative | Positive | | MDMA | 100,000 | Negative | Positive | | Meperidine | 1,563 | Negative | Positive | | Methadone | 50,000 | Negative | Positive | | Compound | Concentration Tested (ng/mL) | -25% of Cutoff (19 ng/mL) | +25% of Cutoff (31 ng/mL) | | S(+) - Methamphetamine | 100,000 | Negative | Positive | | Methaqualone | 100,000 | Negative | Positive | | Morphine | 75,000 | Negative | Positive | | Naproxen | 100,000 | Negative | Positive | | Nordiazepam | 100,000 | Negative | Positive | | Nortriptyline | 75,000 | Negative | Positive | | Oxazepam | 100,000 | Negative | Positive | | Oxycodone | 100,000 | Negative | Positive | | Phenobarbital | 100,000 | Negative | Positive | | Phenylephrine | 100,000 | Negative | Positive | | Phenytoin | 100,000 | Negative | Positive | | Promethazine | 3,125 | Negative | Positive | | Propoxyphene | 100,000 | Negative | Positive | | Propranolol | 100,000 | Negative | Positive | | Protriptyline | 75,000 | Negative | Positive | | R,R - Pseudoephedrine | 100,000 | Negative | Positive | | S,S - Pseudoephedrine | 100,000 | Negative | Positive | | Ranitidine | 100,000 | Negative | Positive | | Ritalinic Acid | 100,000 | Negative | Positive | | Salicylic Acid | 100,000 | Negative | Positive | | Scopolamine | 100,000 | Negative | Positive | | Secobarbital | 100,000 | Negative | Positive | | Tapentadol | 50,000 | Negative | Positive | | 11-nor-A9-THC-9-COOH | 100,000 | Negative | Positive | | Tramadol | 50,000 | Negative | Positive | | Trazodone | 100,000 | Negative | Positive | | Tyramine | 100,000 | Negative | Positive | | Verapamil | 60,000 | Negative | Positive | | Zidovudine (AZT) | 100,000 | Negative | Positive | | Zolpidem | 100,000 | Negative | Positive | {12}------------------------------------------------ - d) Summary of the Effect of Structurally Unrelated Compounds At the stated concentration, the sample did not give a false response relative to the 25 ng/mL cutoff. {13}------------------------------------------------ Boric acid results in a false negative result. The package insert notifies the user of this limitation. # ______________________________________________________________________________________________________________________________________________________________________________ Specificity was determined in accordance with CLSI Document EP07-A2. Structurally similar compounds were spiked into drug free urine at the levels indicated. Crossreactivity was calculated. Summary of Cross-reactivity: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {14}------------------------------------------------ | Test Compound | Concentration Tested (ng/mL) | Cross-Reactivity (%) | |-------------------------------------------------|------------------------------------|-------------------------| | Chloropromazine | 100000 | 0.02 | | Clomipramine | 100000 | 0.02 | | Cyclobenzaprine | 25000 | 0.03 | | Dextromethorphan | 80000 | 0.02 | | Diphenhydramine | 100000 | 0.01 | | Doxepin | 90000 | 0.01 | | Imipramine | 100000 | 0.01 | | Methoxetamine | 36000 | 0.03 | | 4-Methoxyphencyclidine | 700 | 8.43 | | Thioridazine | 100000 | 0.04 | | Venlafaxine | 100000 | 0.01 | | 1-(4- Hydroxypiperidino)phenylcyclohexane | 419 | 5.97 | | 1-(1-Phenylcyclohexyl)pyrrolidine (PCPy) | 54 | 38.33 | | 1-[1-(2-Thienyl)-cyclohexyl]piperidine (TCP) | 37 | 58.11 | | trans-4-phenyl-4- Piperidinocyclohexanol | 32 | 74.38 | # CONCLUSION The Atellica CH Phencyclidine (Pcp) is substantially equivalent to the Urine Phencyclidine Screen Flex® reagent cartridge used on the Dimension clinical chemistry system in principle and performance based on the similarity of device designs and function demonstrated through method comparison and other performance attributes.