Atellica CH Phencyclidine (Pcp)
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 |
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 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
Homogeneous enzyme immunoassay; liquid reagents (polyclonal sheep anti-PCP antibodies, PCP-labeled G6PDH). Spectrophotometric detection at 340/410 nm. Calibrated for 60-day interval. Onboard reagent stability 30 days. Referenced CLSI guidelines: EP05-A3, EP07-A2, EP17-A2, EP25-A. Standalone assay for Atellica CH Analyzer.
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)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k163220
B. Purpose for Submission:
New device
C. Measurand:
Phencyclidine (PCP)
D. Type of Test:
Enzyme immunoassay
E. Applicant:
Siemens Healthcare Diagnostics Inc.
F. Proprietary and Established Names:
Atellica CH Phencyclidine (PCP)
G. Regulatory Information:
1. Regulation section:
Enzyme Immunoassay, Phencyclidine
2. Classification:
Unclassified, 510(k) required
3. Product code:
LCM
4. Panel:
Toxicology (91)
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H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) 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.
3. Special conditions for use statement(s):
Prescription use only.
For In Vitro Diagnostic Use only.
4. Special instrument requirements:
Atellica CH Analyzer
I. Device Description:
The Atellica CH Phencyclidine reagents are liquid, ready to use. There are two reagents packaged in two separate reagent packs. These include a reagent with antibodies to phencyclidine (polyclonal sheep) and glucose-6-phosphate. The second reagent is phencyclidine labeled with bacterial glucose-6-phosphate dehydrogenase.
The Atellica CH Analyzer has been previously cleared as part of the Trinidad CH System under k151767. The assay uses a previously cleared calibrator (k993755).
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J. Substantial Equivalence Information:
1. Predicate device name(s):
Siemens Urine phencyclidine (PCP) screen flex reagent cartridge
2. Predicate 510(k) number(s):
k000462
3. Comparison with predicate:
| Similarities/Differences | | |
| --- | --- | --- |
| Item | k163220
Atellica CH Phencyclidine (PCP)
Candidate Device | k000462
Urine Phencyclidine (PCP)
Screen Flex Reagent Cartridge
Predicate Device |
| Intended Use: | Qualitative or semiquantitative analysis of phencyclidine (PCP) in human urine using the Atellica CH analyzer. | Qualitative or semiquantitative analysis of phencyclidine (PCP) in human urine using the Dimension clinical chemistry system. |
| Methodology: | Enzyme Immunoassay | Same |
| Type of Test: | Qualitative or semiquantitative | Same |
| Specimen Type: | Human urine | Same |
| Cutoff: | 25 ng/mL | Same |
| Intended Users: | Prescription use only | Same |
| Calibration Frequency: | 60 days | 30 days |
K. Standard/Guidance Document Referenced (if applicable):
The following guidelines from the Clinical and Laboratory Standards Institute (CLSI) were referenced:
EP05-A3. Evaluation of Precision Performance of Quantitative Measurement Methods, Approved Guideline; Third edition
EP07-A2. Interference Testing of Clinical Chemistry; Approved Guidelines
EP17-A2. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, Approved Guideline, Second edition
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EP25-A. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline
L. Test Principle:
The Atellica CH PCP assay is a homogenous enzyme immunoassay based on competition between drug present in the specimen and drug labeled-glucose-6-phosphate dehydrogenase (PCP-G6PDH) for antibodies raised to PCP. PCP-G6PDH activity decreases upon binding to the anti-PCP antibodies and free PCP in the specimen competitively prevents this binding, so that PCP-G6PDH enzyme activity is proportional to drug concentration in the specimen. Active PCP-G6PDH enzyme converts nicotinamide adenine dinucleotide (NAD+) to NADH in the presence of glucose-6-phosphate, resulting in an absorbance change that is measured spectrophotometrically at 340/410 nm.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Precision study samples were prepared from negative urine samples spiked with nine different concentrations: +100%, +75%, +50%, +25%, cut-off, -25%, -50%, -75% and -100% of the drug cutoff concentration (25 ng/mL) for PCP. Precision was tested using two replicates, two times a day for at least 20 days for a total of at least 80 replicates. The results in the qualitative mode and semi-quantitative mode are identical. The results are summarized below.
| Urine Pool (ng/mL) | % of Cutoff | # of Results | Repeatability and Within-Laboratory Results |
| --- | --- | --- | --- |
| 0 | -100 | 80 | 80 Negative |
| 6.25 | -75 | 80 | 80 Negative |
| 12.5 | -50 | 80 | 80 Negative |
| 18.75 | -25 | 80 | 80 Negative |
| 25 | Cut-off | 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. Linearity/assay reportable range:
Urine samples were spiked with PCP concentrations ranging from 4.0 - 80.0 ng/mL. Seven replicates were processed in the same analytical run. For each known
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concentration, drug recovery was calculated using the mean concentration of the replicates. The data support the semi-quantitative reportable range of 5 - 75 ng/mL. The data are summarized below.
| 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 |
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The assay uses previously cleared calibrators (k993755).
Reagent Stability:
A real time stability study to support a claim of 12 months shelf life is ongoing. Unopened reagents are stable until the expiration date on the product when stored at 2 - 8 °C. Reagents are stable onboard the system for 30 days.
Calibration Interval:
All protocols and acceptance criteria for Lot Calibration and Pack Calibration Intervals were reviewed and found to be acceptable. The study results support a calibration interval of 60 days and a pack calibration interval of 19 days.
d. Detection limit:
Not applicable.
e. Analytical specificity:
Cross-reactivity was evaluated by spiking the structurally similar compounds shown below into drug free urine. All samples were tested in replicates of N = 6. The results are summarized in the table below.
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| Compound | % Cross-Reactivity |
| --- | --- |
| 1-(4-Hydroxypiperidino)phenylcyclohexane | 5.97 |
| 1-(1-Phenylcyclohexyl)pyrrolidine | 38.33 |
| 1-[1-(2-Thienyl)-cyclohexyl]piperidine | 58.11 |
| trans-4-phenyl-4-Piperidinocyclohexanol | 74.38 |
| Chlorpromazine | 0.02 |
| Clomipramine | 0.02 |
| Cyclobenzaprine | 0.03 |
| Dextromethorphan | 0.02 |
| Diphenhydramine | 0.01 |
| Doxepin | 0.01 |
| Imipramine | 0.01 |
| Methoxetamine | 0.03 |
| 4-Methoxyphencyclidine | 8.43 |
| Thioridazine | 0.04 |
| Venlafaxine | 0.01 |
Endogenous interferents were evaluated by spiking urine aliquots, with PCP concentrations at $+/-25\%$ of the cutoff, with endogenous interferents at the below indicated concentrations. No positive or negative interference was detected at the indicated concentrations.
| Compound | Concentration Tested |
| --- | --- |
| Acetone | 1.0 g/dL |
| Ascorbic Acid | 0.75 g/dL |
| Conjugated bilirubin | 0.25 mg/dL |
| Creatinine | 0.5 g/dL |
| Ethanol | 1.0 g/dL |
| Gamma Globulin | 0.5 g/dL |
| Galactose | 0.01 g/dL |
| Glucose | 2.0 g/dL |
| Hemoglobin | 115 mg/dL |
| Human Serum Albumin | 0.5 g/dL |
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| Oxalic Acid | 0.1 g/dL |
| --- | --- |
| Riboflavin | 7.5 mg/dL |
| Sodium Azide | 1% (w/v) |
| Sodium Chloride | 1.5 g/dL |
| Sodium Fluoride | 1% (w/v) |
| Urea | 6.0 g/dL |
Structurally unrelated interferents were evaluated by spiking urine aliquots, with PCP with concentrations at +/-25% of the cutoff, with structurally unrelated interferents at the below indicated concentrations. No positive or negative interference was detected at the indicated concentrations.
| Compound | Concentration Tested (ng/mL) |
| --- | --- |
| Acetaminophen | 500,000 |
| I-α-Acetylmethadol (LAAM) | 25,000 |
| N-Acetyl Procainamide (NAPA) | 100,000 |
| Acetylsalicylic Acid | 500,000 |
| Amitriptyline | 8,750 |
| S-(+)-Amphetamine | 100,000 |
| Benzoylecgonine | 100,000 |
| Buprenorphine | 100,000 |
| Caffeine | 500,000 |
| Cannabinol | 100,000 |
| Carbamazepine | 100,000 |
| Chlordiazepoxide | 100,000 |
| Cimetidine | 100,000 |
| Clonidine | 100,000 |
| Codeine | 25,000 |
| Cotinine | 100,000 |
| Desipramine | 75,000 |
| Dextrorphan | 781 |
| Diazepam | 100,000 |
| Digoxin | 100,000 |
| 2-Ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 12,500 |
| EMDP | 100,000 |
| 1R,2S-Ephedrine | 100,000 |
| 1S,2R-Ephedrine | 100,000 |
| Fluoxetine | 75,000 |
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| Compound | Concentration Tested (ng/mL) |
| --- | --- |
| Flurazepam | 50,000 |
| Glutethimide | 100,000 |
| Haloperidol | 100,000 |
| Heroin | 25,000 |
| Hydrocodone | 25,000 |
| Ibuprofen | 500,000 |
| Ketamine | 75,000 |
| Ketorolac Tromethamine | 100,000 |
| Lidocaine | 100,000 |
| Lorazepam | 100,000 |
| Lormetazepam | 100,000 |
| LSD | 100,000 |
| MDMA | 100,000 |
| Meperidine | 1,563 |
| Methadone | 50,000 |
| S(+) - Methamphetamine | 100,000 |
| Methaqualone | 100,000 |
| Morphine | 75,000 |
| Naproxen | 100,000 |
| Nordiazepam | 100,000 |
| Nortriptyline | 75,000 |
| Oxazepam | 100,000 |
| Oxycodone | 100,000 |
| Phenobarbital | 100,000 |
| Phenylephrine | 100,000 |
| Phenytoin | 100,000 |
| Promethazine | 3,125 |
| Propoxyphene | 100,000 |
| Propranolol | 100,000 |
| Protriptyline | 75,000 |
| R,R - Pseudoephedrine | 100,000 |
| S,S - Pseudoephedrine | 100,000 |
| Ranitidine | 100,000 |
| Ritalinic Acid | 100,000 |
| Salicylic Acid | 100,000 |
| Scopolamine | 100,000 |
| Secobarbital | 100,000 |
| Tapentadol | 50,000 |
| 11-nor-Δ9-THC-9-COOH | 100,000 |
| Tramadol | 50,000 |
| Trazodone | 100,000 |
| Tyramine | 100,000 |
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| Compound | Concentration Tested (ng/mL) |
| --- | --- |
| Verapamil | 60,000 |
| Zidovudine (AZT) | 100,000 |
| Zolpidem | 100,000 |
Boric acid 1% (w/v) results in a false negative result. The labeling states that boric acid not be used as a preservative for urine samples.
Effect of specific gravity: To evaluate the effect of specific gravity, the specific gravity of drug-free urine samples was adjusted with water or addition of creatinine to obtain the following values: 1.000, 1.002, 1.005, 1.010, 1.015, 1.020, 1.025, and 1.030. Specimens were spiked with PCP at ± 25% of the cutoff values. Six replicates of each specific gravity value and PCP concentration were performed. No positive or negative interference was detected with changes in specific gravity.
Effect of pH: To evaluate the effects of pH, drug-free urine was adjusted to 3.0 to 11.0 (+/- 0.2) in increments of 1 pH unit using 0.1N HCL or 0.1N NaOH. Urine pools were spiked with PCP at 25% below and 25% above the cutoff concentrations. Six replicates of each pH value and PCP concentration were analyzed. The pH ranges tested did not affect the results from the device.
f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, M.1.a., above.
2. Comparison studies:
a. Method comparison with predicate device:
A total of 106, unaltered phencyclidine samples, and 6 altered samples (to achieve below cutoff levels), were analyzed using the Atellica CH PCP Assay and the reference method GC/MS. Results were obtained as positive or negative relative to the 25 ng/mL assay cutoff (qualitative mode) or in analyte units (semi-quantitative mode) on the Atellica CH. One replicate was processed for each sample. Twenty-eight samples were within +/- 50% of the cutoff by GC/MS. The results are summarized below by GC/MS and concordance agreement by Atellica CH Phencyclidine:
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| | GC/MS Results | | | | |
| --- | --- | --- | --- | --- | --- |
| Atellica PCP | 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% |
| Semi-Quantitative | | | | | |
| Atellica Pos | 0 | 1 | 17 | 36 | 98% |
| Atellica Neg | 48 | 7 | 3 | 0 | 95% |
Discordant Samples between Atellica CH Phencyclidine and GC/MS:
| Sample ID | Atellica Semi-quant. Value | GC/MS Value (ng/mL) | Atellica Pos/Neg | GC/MS Pos/Neg |
| --- | --- | --- | --- | --- |
| 53 | 25 | 23.7 | Pos | Neg |
| 57 | 23 | 25.3 | Neg | Pos |
| 59 | 23 | 28.2 | Neg | Pos |
| 61 | 22 | 30.0 | Neg | Pos |
b. Matrix comparison:
Not applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
None
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4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Not applicable
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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