(141 days)
Not Found
No
The device description and performance studies detail a standard enzyme immunoassay and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic assay used to detect phencyclidine in human urine, providing analytical results, not directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the assay is "for in vitro diagnostic use" in the analysis of phencyclidine in human urine, which directly indicates its purpose in diagnosing the presence of PCP.
No
The device description clearly states it 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." This describes a chemical reagent-based test, not a software-only device. The Atellica CH Analyzer is also mentioned as the platform, which is a hardware analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "The Atellica™ CH Phencyclidine (Pcp) assay is for in vitro diagnostic use in the qualitative or semiquantitative analyses of phencyclidine in human urine..." This is a direct statement of its intended use as an IVD.
- Device Description: The description details a laboratory test performed on a biological specimen (human urine) using an immunoassay method to detect a substance (phencyclidine). This aligns with the definition of an in vitro diagnostic device.
- Performance Studies: The document includes detailed performance studies (Precision, Method Comparison, Interferences, Specificity) which are typical for demonstrating the analytical performance of an IVD.
- Key Metrics: The presentation of results in terms of qualitative and semi-quantitative analysis, agreement with a reference method (GC/MS), and cross-reactivity are all standard metrics for evaluating the performance of an IVD for drug testing.
- Predicate Device(s): The mention of a predicate device which is also a "URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE" further supports that this device falls within the category of IVDs used for drug screening.
N/A
Intended Use / Indications for 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 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.
Product codes
LCM
Device Description
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Method comparison study: 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.
Qualitative Analysis (25 ng/mL cutoff) sample size: 80 results for each concentration level (0 ng/mL, 6.25 ng/mL, 12.5 ng/mL, 18.75 ng/mL, 25 ng/mL, 31.25 ng/mL, 37.5 ng/mL, 43.75 ng/mL, 50 ng/mL).
At the 25 ng/mL cutoff, out of 80 results, there were 60 Positive / 20 Negative.
Semi-quantitative analysis (25 ng/mL cutoff) sample size: 80 results for each concentration level (0 ng/mL, 6.25 ng/mL, 12.5 ng/mL, 18.75 ng/mL, 25 ng/mL, 31.25 ng/mL, 37.5 ng/mL, 43.75 ng/mL, 50 ng/mL).
At the 25 ng/mL cutoff, out of 80 results, there were 60 Positive / 20 Negative.
Method Comparison Qualitative Results:
Atellica (+) vs GC/MS (+): 53
Atellica (+) vs GC/MS (-): 1
Atellica (-) vs GC/MS (+): 3
Atellica (-) vs GC/MS (-): 55
Qualitative Assay Performance for 25 ng/mL cutoff (compared to GC/MS):
Atellica Pos for Neg ( 38 ng/mL) GC/MS: 36
Percentage Agreement for Atellica Pos: 98%
Atellica Neg for Neg ( 38 ng/mL) GC/MS: 0
Percentage Agreement for Atellica Neg: 95%
Recovery Study:
Spiked Pcp (ng/mL) vs. Mean Pcp (ng/mL) and % Recovery ranging from 107.5% at 4.0 ng/mL to 104.6% at 80.0 ng/mL.
Interference study: Compounds evaluated by spiking into drug free urine containing target analyte at ±25% of cutoff. Effects of pH, specific gravity, endogenous compounds, and structurally unrelated compounds were assessed. Boric acid resulted in a false negative result.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Qualitative Assay Performance for the 25 ng/mL cutoff:
% Agreement for Atellica Pos: 98%
% Agreement for Atellica Neg: 95%
Predicate Device(s)
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE (K000462)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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)
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)
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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 ( 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 ( 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.