ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000
Device Facts
| Record ID | K060353 |
|---|---|
| Device Name | ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 |
| Applicant | Acro Biotech, LLC |
| Product Code | LCM · TX |
| Decision Date | May 3, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
Indications for Use
The Acro Rapid Phencyclidine Urine Test is a lateral flow, one step immunoassay for the qualitative determination of phencyclidine in human urine at a cutoff of 25 ng/mL. The test is used to obtain a visual qualitative result and is intended for central laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) analysis is preferred.
Device Story
Lateral flow, one-step immunoassay for qualitative detection of Phencyclidine in human urine. Device utilizes competitive binding principle; drug in urine competes with drug conjugate for limited antibody binding sites. Visual qualitative result produced on test strip. Intended for central laboratory use by trained personnel. Provides preliminary screening results; requires confirmation by more specific alternate chemical method, preferably GC/MS. Clinical judgment required for interpretation of preliminary positive results.
Clinical Evidence
No clinical studies performed. Bench testing included precision studies across four sites (n=60 per concentration level) and method comparison against GC/MS and predicate (n=130 samples). Method comparison showed 90% agreement among positives and 96% agreement among negatives relative to GC/MS. Analytical specificity and interference testing (pH, specific gravity, and various compounds) showed no deviations from expected results.
Technological Characteristics
Lateral flow immunochromatographic assay. Cassette format. Reagents: monoclonal mouse anti-PCP antibody (test line), polyclonal goat anti-mouse antibody (control line). Qualitative visual readout. Single-use. No instrumentation required.
Indications for Use
Indicated for the qualitative detection of phencyclidine (PCP) in human urine at a 25 ng/mL cutoff. Intended for professional use in central laboratory settings to obtain preliminary results. Requires confirmation by alternate chemical methods such as GC/MS.
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
k060353
B. Purpose for Submission:
New device
C. Measurand:
Phencyclidine (PCP)
D. Type of Test:
Qualitative immunoassay
E. Applicant:
Acro Biotech LLC
F. Proprietary and Established Names:
Acro Rapid Phencyclidine Urine Test
G. Regulatory Information:
1. Regulation section:
Unclassified
2. Classification:
Unclassified, 510(k) required
3. Product Code:
LCM, Enzyme Immunoassay, PCP
4. Panel:
Toxicology (91)
H. Intended Use:
1. Intended use(s):
Refer to Indications for use.
2. Indication(s) for use:
The Acro Rapid Phencyclidine Urine Test is a lateral flow, one step immunoassay for the qualitative determination of phencyclidine in human urine at a cutoff of 25 ng/mL. The test is used to obtain a visual qualitative result and is intended for central laboratory use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed
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analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) analysis is preferred.
1. Special condition for use statement(s):
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) analysis is preferred
The device is for in vitro diagnostic use.
For central laboratory use only.
2. Special instrument Requirements:
Not applicable. The device is a visually read single-use device.
F. Device Description
The product is a single-use device in a cassette format. Operators add several drops of the sample to the sample well. The test reaction is initiated by movement of the sample through the test strip.
Description of the test antibody: monoclonal mouse antibody against phencyclidine.
Description of the control line antibody: polyclonal goat anti-mouse.
G. Substantial Equivalence Information:
1. Predicate device name(s):
Ameditech ImmuTest Drug Screen PCP
2. Predicate K number(s):
k012582
3. Comparison with predicate:
Both devices are for the qualitative determination of the same analyte in the same matrix, and utilize the same cutoff concentration. Both are visually-read single use devices.
The reagent formulations vary between the two devices.
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Target User Population | Professional Users | Same |
| Cutoff | 25 ng/mL | Same |
| Matrix | Urine | Same |
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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Methodology | Qualitative Lateral Flow Immunochromatographic | Same |
| Internal Control | Included; indicates adequate sample volume and integrity of test strip | Same |
| Differences | | |
| Item | Device | Predicate |
| Test Line Antibodies | Mouse anti-PCP | Mouse anti-PCP and rabbit antibodies |
| Control Line Antibodies | Goat anti-mouse | Goat anti-rabbit |
**H. Standard/Guidance Document Referenced (if applicable):**
The sponsor did not reference any standards in their submission.
**I. Test Principle:**
The test employs lateral flow immunochromatographic technology.
Drug in the sample and drug-labeled conjugate (containing a chromagen) compete for antibody binding sites in the test area of the test strip. Binding of drug in the sample causes the absence of a line at the test area, i.e., a positive result. When drug is not present in the sample, the drug-labeled conjugate binds at the test line, resulting in formation of a line, i.e., a negative result. The absence or presence of the line is determined visually by the operator.
The device also has an internal process control which indicates that an adequate volume of sample has been added and that the immunochromatographic strip is intact.
**J. Performance Characteristics (if/when applicable):**
1. Analytical performance:
a. Precision/Reproducibility:
Although this assay is intended for central laboratory use only, the sponsor collected precision data at four sites including a hospital laboratory and three biotechnology companies. Phencyclidine was spiked into drug free urine at the concentrations listed below. There was one operator per site and all 60 results (4 levels X 15 replicates per level) were run in one day by that operator.
Lots of product used: four
Operator: the sponsor states that all operators had at least one year of experience in research and development of immunoassays. One operator was an employee of the sponsor, one was a laboratorian, and two were employees of biotechnology companies.
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Results of the study are presented below:
Site 1
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 0 | 15 | 15/0 |
| 12.5 | 15 | 15/0 |
| 18.75 | 15 | 11/4 |
| 25 | 15 | 7/8 |
| 31.25 | 15 | 8/7 |
| 37.5 | 15 | 0/15 |
| 50 | 15 | 0/15 |
Site 2
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 0 | 15 | 15/0 |
| 12.5 | 15 | 15/0 |
| 18.75 | 15 | 13/2 |
| 25 | 15 | 6/9 |
| 31.25 | 15 | 5/10 |
| 37.5 | 15 | 0/15 |
| 50 | 15 | 0/15 |
Site 3
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 0 | 15 | 15/0 |
| 12.5 | 15 | 15/0 |
| 18.75 | 15 | 10/5 |
| 25 | 15 | 8/7 |
| 31.25 | 15 | 1/14 |
| 37.5 | 15 | 0/15 |
| 50 | 15 | 0/15 |
Site 4
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 0 | 15 | 15/0 |
| 12.5 | 15 | 15/0 |
| 18.75 | 15 | 13/2 |
| 25 | 15 | 5/10 |
| 31.25 | 15 | 1/14 |
| 37.5 | 15 | 0/15 |
| 50 | 15 | 0/15 |
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Combined data from all four sites
| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 0 | 60 | 60/0 |
| 12.5 | 60 | 60/0 |
| 18.75 | 60 | 47/13 |
| 25 | 60 | 26/34 |
| 31.25 | 60 | 15/45 |
| 37.5 | 60 | 0/60 |
| 50 | 60 | 0/60 |
b. Linearity/assay reportable range:
Not applicable. The assay is intended for qualitative use.
c. Traceability (controls, calibrators, or method):
Control materials are required but are not specifically identified in the labeling.
The device has an internal process control. Users are instructed to follow federal, state, and local guidelines when determining when to run external controls.
d. Detection limit
Sensitivity of this assay is characterized by validating performance around the claimed cutoff concentration of the assay, including a determination of the lowest concentration of drug that is capable of producing a positive result. In addition to the precision study in section M.1.a above, the sponsor performed an in-house study using spiked samples at concentrations of 0, 12.5, 18.75, 25, 31.25, 37.5, and 50 ng/mL. Results were as follows:
| Phencyclidine Conc. | # Tested | # Positive (+) | # Negative (-) |
| --- | --- | --- | --- |
| 0 | 60 | 0 | 60 |
| 12.5 ng/mL | 60 | 0 | 60 |
| 18.75 ng/mL | 60 | 13 | 47 |
| 25 ng/mL | 60 | 34 | 26 |
| 31.25 ng/mL | 60 | 45 | 15 |
| 37.5 ng/mL | 60 | 60 | 0 |
| 50 ng/mL | 60 | 60 | 0 |
e. Analytical specificity:
Cross-reactivity was established by spiking various concentrations of similarly structured drug compounds into drug-free urine /a negative control. By analyzing various concentration of each compound the
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sponsor determined the concentration of the drug that produced a response approximately equivalent to the cutoff concentration of the assay. Results of those studies appear in the table(s) below:
**Phencyclidine**
| Compound | Response equivalent to cutoff in ng/mL |
| --- | --- |
| Phencyclidine | 25 |
| 4-hydroxyphencyclidine | 12,500 |
| Phencyclidine Morpholine | 12.5 |
The following compounds were evaluated for potential positive or negative interference with the assay. To evaluate for interference the sponsor prepared three control samples: one consisted of drug-free urine only, one consisted of drug-free urine spiked with PCP at 12.5 ng/mL, and one consisted of drug-free urine spiked with PCP at 50 ng/mL. Potentially interfering substances were added to the three control samples at concentrations of 10 and 100 µg/mL to test for positive or negative interference. No deviations from the expected results were observed.
(+)-Chlorpheniramine
Diphenhydramine
(+)-Naproxen
Dopamine
(+/-) - Norephedrine
Erythromycin
(+/-)-Chlorpheniramine
Ethanol
(+/-)-Epinephrine
Furosemide
(+/-)-Isoproterenol
Glucose
/3-Phenylethylamine
Guaiacol Glyceryl Ether
1-Phenylephrine
Hemoglobin
4-Dimethylaminoantipine
Ibuprofen
(1 R, 2S)-(+N-Methyl-
Ephedrine
Ketamine
Acetaminophen
Levorphanol
Acetone
Lidocaine
Acetylsalicylic Acid
Niacinamide
Albumin
Nicotine
Ampicillin
Oxalic Acid
Ascorbic acid
Penicillin-G
Aspartame
Phenothiazine
Atropine
Procaine
Benzocaine
Quinidine
Bilirubin
Ranitidine
Caffeine
Riboflavin
Chloroquine
Sodium Chloride
Creatine
Sulindac
Dexbrompheniramine
Theophylline
Dextromethorphan
Tyramine
Dextromethorphan
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There is the possibility that other substances and/or factors not listed above may interfere with the test and cause false results, e.g., technical or procedural errors.
To test for potential positive or negative interference from endogenous conditions the sponsor prepared study control samples. The control samples consisted of drug-free urine spiked with phencyclidine at 50% above and below the cutoff. Aliquots of the control sample were then altered to span the following ranges of conditions, analyzed, and compared to the unaltered control samples:
4-9 pH
1.005 to 1.030 specific gravity
No deviations from the expected results were observed.
f. Assay cut-off:
The identified cutoff concentration of the assay is recommended for use by the Substance Abuse and Mental Health Services Administration (SAMHSA).
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, above.
2. Comparison studies:
a. Method comparison with predicate device:
The candidate device was compared both to a reference method, GC/MS, and to the predicate device.
A total of 130 samples (81 negative and 49 positive) were evaluated by the candidate device and by GC/MS and/or the predicate device.
Sample description: Unaltered clinical urine samples were evaluated.
Sample selection: seventy presumed zero concentration samples were collected from self-declared non-drug users. All 70 samples were compared to the predicate device and 19% of these samples were confirmed by GC-MS. The remainder of the samples all contained phencyclidine (some below and some above the cutoff) and were compared to GC-MS.
The study included an adequate number of samples that contained drugs near to the cutoff concentration of the assay. Approximately 10% of the study samples are evenly distributed between plus and minus 50% of the claimed cutoff concentration.
Number of study sites: two
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Type of study site(s): one biotechnology company, one clinical setting
Operator description: one manufacturer's staff, one clinical site staff
Candidate Device Results vs. stratified GC/MS Values
| Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis or negative by the predicate device* | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- |
| Positive | 0 | 3 | 7 | 37 |
| Negative | 71 | 7 | 5 | 0 |
*57 of these samples were from self-declared non-drug users but were not confirmed by GC-MS.
GC/MS values used to categorize samples in this table are based on the concentration of phencyclidine found in the sample.
% Agreement among positives is 90%
% Agreement among negatives is 96%
b. Matrix comparison:
Not applicable. The assay is intended for only one sample matrix.
3. Clinical studies:
a. Clinical sensitivity:
Not applicable. Clinical studies are not typically submitted for this device type.
b. Clinical specificity:
Not applicable. Clinical studies are not typically submitted for this device type.
c. Other clinical supportive data (when a and b are not applicable):
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10
L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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