← Product Code [LCM](/productcode/LCM) · K163220

# Atellica CH Phencyclidine (Pcp) (K163220)

_Siemens Healthcare Diagnostics, Inc. · LCM · Apr 6, 2017 · TX · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K163220

## Device Facts

- **Applicant:** Siemens Healthcare Diagnostics, Inc.
- **Product Code:** [LCM](/productcode/LCM.md)
- **Decision Date:** Apr 6, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** TX
- **Attributes:** Real-World Evidence

## Real-World Evidence

| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
| --- | --- | --- | --- | --- | --- |
| K163220 · Apr 6, 2017 | Atellica CH Phencyclidine (Pcp) | Siemens Healthcare Diagnostics, Inc. | Anonymous, discarded clinical urine samples | Method comparison study comparing the Atellica CH Phencyclidine (Pcp) assay performance against a GC/MS reference method using clinical urine samples. | Method comparison; Clinical urine samples; Diagnostic accuracy |

### Clinical Evidence

| Study Design | Population | Comparator | Key Endpoints |
| --- | --- | --- | --- |
| Method comparison study | Clinical urine samples; Sample Size: Not explicitly stated (total count derived from contingency table: 112 samples) | GC/MS (Gas Chromatography/Mass Spectrometry) | Qualitative and semi-quantitative agreement with reference method |

## 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.

## Predicate Devices

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

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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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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**Source:** [https://fda-staging.innolitics.com/device/K163220](https://fda-staging.innolitics.com/device/K163220)

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