RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
Device Facts
| Record ID | K122703 |
|---|---|
| Device Name | RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR |
| Applicant | Biophor Diagnostics, Inc. |
| Product Code | LCM · TX |
| Decision Date | Apr 25, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
Indications for Use
The RapidFRET Oral Fluid Assay for PCP is a homogeneous time-resolved fluorescence assay that is intended for use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Phencyclidine at 10 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For in vitro diagnostic use only. The RapidFRET Oral Fluid PCP Calibrator Set and the RapidFRET Oral Fluid PCP Control Set are intended for use only with the RapidFRET Oral Fluid Assay for PCP and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For in vitro diagnostic use only.
Device Story
The RapidFRET Oral Fluid Assay for PCP is a homogeneous time-resolved fluorescence immunoassay used for qualitative drug screening. It utilizes the RapidEASE Oral Fluid Collector to obtain neat oral fluid samples. The assay operates on the RapidFRET Integrated Workstation, which automates all pipetting and reading steps. The principle of operation is a competitive immunoassay based on Fluorescence Resonance Energy Transfer (FRET); drug in the sample competes with donor-fluorophore-labeled drug for binding sites on an acceptor-fluorophore-labeled antibody. When binding occurs, energy transfer produces a signal inversely proportional to the drug concentration. The workstation software processes the fluorescence signal, comparing it against a 10 ng/mL cutoff calibrator to provide a qualitative positive or negative result. The device is intended for use in central laboratories; results are preliminary and require confirmation by GC/MS or LC/MS/MS. The system aids healthcare providers in identifying potential PCP use, necessitating professional judgment for clinical decision-making.
Clinical Evidence
No clinical data. Performance was established via bench testing, including precision studies (n=88 per concentration level), analytical specificity (testing 40,000 ng/mL for cross-reactants), and a method comparison study (n=246 samples) against GC/MS reference methods. Method comparison showed 100% agreement among positives and 99% agreement among negatives.
Technological Characteristics
Homogeneous time-resolved fluorescence immunoassay. Reagents: liquid, ready-to-use PCP-specific antibody and drug conjugate. Platform: RapidFRET Integrated Workstation. Sample collection: RapidEASE Oral Fluid Collector (direct expectoration, no diluent, glass tube). Cutoff: 10 ng/mL. Detection principle: FRET signal measurement.
Indications for Use
Indicated for qualitative screening of Phencyclidine (PCP) in neat oral fluid at a 10 ng/mL cutoff. Intended for use in central laboratories by professional personnel. Not for point-of-care settings.
Predicate Devices
- Thermo Scientific CEDIA® Phencyclidine (PCP) OFT Assay (k101746)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k122703
B. Purpose for Submission:
New device
C. Measurand:
Phencyclidine (PCP)
D. Type of Test:
Qualitative immunoassay
E. Applicant:
Biophor Diagnostics, Inc.
F. Proprietary and Established Names:
RapidFRET Oral Fluid Assay for PCP
RapidFRET Oral Fluid PCP Calibrator Set
RapidFRET Oral Fluid PCP Control Set
RapidEASE Oral Fluid Collector
RapidFRET Integrated Workstation
G. Regulatory Information:
1. Regulation section:
862.3100, Enzyme immunoassay, phencyclidine
862.3200, clinical toxicology calibrator
862.3280, clinical toxicology control material
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2. Classification:
Unclassified, 510(k) required
Class II
Class I, reserved
3. Product code:
LCM, enzyme immunoassay, phencyclidine
DKB, calibrator, drug mixture
DIF, drug mixture control materials
4. Panel:
Toxicology (91)
H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
The RapidFRET Oral Fluid Assay for PCP is a homogeneous time-resolved fluorescence assay that is intended for use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Phencyclidine at 10 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For in vitro diagnostic use only.
The RapidFRET Oral Fluid PCP Calibrator Set and the RapidFRET Oral Fluid PCP Control Set are intended for use only with the RapidFRET Oral Fluid Assay for PCP and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For in vitro diagnostic use only.
3. Special conditions for use statement(s):
For prescription use in central laboratories only.
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The assay is not designated for use in point-of-care settings.
4. Special instrument requirements:
RapidFRET Integrated Workstation instrument
I. Device Description:
The assay consists of PCP Acceptor Reagent (Reagent A), PCP Donor Reagent (Reagent B), Matrix Blank Reagent, the RapidEASE Oral Fluid Collector, Negative Calibrator (0 ng/mL), Cutoff Calibrator (10 ng/mL), Negative Control (5 ng/mL), Positive Control (15 ng/mL), and 96 Well Microtiter Plates. All pipetting and reading steps are controlled by the software and performed automatically on the RapidFRET Integrated Workstation instrument.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Thermo Scientific CEDIA® Phencyclidine (PCP) OFT Assay
2. Predicate 510(k) number(s):
k101746
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device (RapidFRET Oral Fluid Assay for PCP) | Predicate (k101746) |
| Indications for Use | Same | Qualitative determination of phencyclidine in human oral fluid. |
| Methodology | Same | Homogeneous competitive immunoassay |
| Kit Reagents | Same | PCP specific antibody reagent, PCP drug conjugate reagent |
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| Differences | | |
| --- | --- | --- |
| Item | Candidate Device
(RapidFRET Oral Fluid Assay for PCP) | Predicate (k101746) |
| Reagent Formulation | Liquid, ready-to-use | Lyophilized, with reconstitution buffer |
| Cutoff | 10 ng/mL | 3 ng/mL |
| Sample Collection Device | Neat oral fluid is collected with the RapidEASE Oral Fluid Collector via direct expectoration. No diluent is used and sample is stored in a glass sample tube with inert screw cap. | Oral fluid is collected with the Oral-Eze Saliva Collection System using an absorbent swab and diluent. Sample is stored in a plastic tube with snap cap. |
K. Standard/Guidance Document Referenced (if applicable):
None referenced
L. Test Principle:
The RapidFRET Oral Fluid Assay for PCP is a competitive immunoassay used to detect PCP in human oral fluid. It is a homogenous assay that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to monitor the precision and accuracy of the assay.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Three independently manufactured lots of RapidFRET reagent were evaluated in the precision study at concentrations of negative (zero),
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cutoff, +/-25%, +/-50%, +/-75% and 100% of the cutoff. All data was generated in-house in a simulated laboratory environment using a single RapidFRET Integrated Workstation instrument. Study data collection days typically had 4 complete runs per day with singlicate data collected for each PCP concentration during each run.
Representative data from lot 1 is summarized below. The percentage of negative and positive results was consistent across the three lots tested.
Precision data from lot 1 was collected over 43 days total with 22 data collection days. Two professional laboratory operators were used to collect this data. Results are summarized below.
| Analyte | Concentration (eg, -75%) | Number of Determinations | Number of negative results | Number of positive results |
| --- | --- | --- | --- | --- |
| PCP | 0 | 88 | 88 | 0 |
| PCP | -75% | 88 | 88 | 0 |
| PCP | -50% | 88 | 88 | 0 |
| PCP | -25% | 88 | 88 | 0 |
| PCP | Cutoff | 88 | 88 | 0 |
| PCP | +25% | 87 | 0 | 87 |
| PCP | +50% | 88 | 0 | 88 |
| PCP | +75% | 88 | 0 | 88 |
| PCP | +100% | 88 | 0 | 88 |
b. Linearity/assay reportable range:
Not applicable. This is a qualitative assay.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability – Calibrators and Controls
Calibrators and controls are ready-to-use synthetic oral fluid solutions.
The cutoff calibrator and controls are prepared by spiking known concentrations of PCP into synthetic oral fluid to obtain the cutoff level calibrator, and the positive and negative controls. The negative calibrator is drug free synthetic oral fluid.
Calibrators and controls are prepared from Phencyclidine, 1 mg/mL in methanol commercial primary standards, which use NIST traceable weights and specific assays, such as GC/MS, to confirm drug levels. Certificates of Analysis are available for all standards at time of purchase.
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# Stability - Calibrators and Controls
Real-time stability studies were conducted for the calibrators and controls. Protocols and acceptance criteria were reviewed and found to be acceptable. The shelf life (closed-vial) claim for the calibrators and controls is 12 months when stored at 2 - 8°C. The opened-vial claim for the calibrators and controls is 30 days when stored at 2 - 8°C.
# Value Assignment – Calibrators and Controls
Calibrator and Control lots are value assigned during the manufacturing process in two steps. First, following bottling and labeling, sampled vials are assayed against at least one previously accepted, released and unexpired Calibrator and Control lot using Rapid FRET reagents. Results are qualitatively evaluated for performance relative to the previously accepted lots. Second, each new manufactured lot of Calibrator or Control (POS and NEG) is quantitatively confirmed by GC/MS for target analyte concentration externally by a SAMHSA certified lab. Protocols and acceptance criteria were reviewed and found to be acceptable.
# Sample Shipping Study
To evaluate shipping stability, oral fluid pool samples were prepared at approximately 0%, 25%, 50%, 75%, 100%, 125%, 150%, 175% and 200% of the cutoff, mixed thoroughly and poured into a Rapid EASE Collector to mimic actual usage as closely as possible. Samples were packaged according to the Rapid EASE product insert and carrier instructions and shipped multiple times from California to Maine and back again. Following shipping, all samples were assayed with Rapid FRET reagents against GC/MS quantified calibrators and controls. During the 17 day study, temperatures ranged from approximately 4 – 30°C and the relative humidity (RH) ranged from 7% to 100%. The data support the sponsor’s shipping claim stability of up to 7 days. Recoveries comparing pre-shipping concentrations vs. post-shipping concentrations ranged from 92% to 100%.
# Sample Stability Study
In this study a neat oral fluid pool was spiked with PCP at 0 - 200% of cutoff corresponding to approximately 0 ng/ml, 2.5 ng/ml, 5.0 ng/ml, 7.5 ng/ml, 10 ng/ml, 12.5 ng/ml, 15 ng/ml, 17.5 ng/ml and 20 ng/ml. Six sets of nine samples each (54 total spikes) were prepared and 2 sets (18 samples) were stored at room temperature, two sets (18 samples) were stored refrigerated and the remaining two sets (18 samples) were frozen. Samples from each set were periodically assayed with the Rapid FRET Oral Fluid Assay for PCP using GC/MS confirmed calibrators and
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controls. Recovery for samples stored at room temperature ranged from 100% to 111.5%. Recovery for refrigerated samples ranged from 100% to 110.7%, and for frozen samples ranged from 92% to 108.7%. Samples are stable for up to 7 days at room temperature, up to 21 days at 2 – 8°C, and up to six months at -10 to -25°C.
## Sample Recovery Study
A sample recovery study was performed in conjunction with the precision studies. An oral fluid pool was spiked with known quantities of PCP at nine different levels between 0 ng/mL and 20 ng/mL. These spikes were processed through a new RapidEASE Oral Fluid collector including the funnel, mimicking as close as possible actual collection protocol. The sample was then stored according to the product package insert and samples were removed for analysis by the reference method (GC/MS). Recoveries ranged from a low of 86% to a high of 104%. Results are summarized in the table below:
| Target Value (ng/mL) | Measured Value Mean (ng/mL) | Percent Recovery |
| --- | --- | --- |
| 0 | 0.0 | n/a |
| 2.5 | 2.6 | 104 |
| 5.0 | 4.5 | 90 |
| 7.5 | 6.9 | 92 |
| 10.0 | 9.1 | 91 |
| 12.5 | 10.9 | 87 |
| 15.0 | 12.9 | 86 |
| 17.5 | 15.3 | 87 |
| 20.0 | 17.7 | 88 |
## d. Detection limit:
Not applicable. This is a qualitative assay.
## e. Analytical specificity:
The sponsor performed studies to evaluate the effects of structurally related and structurally unrelated compounds, and food, drinks, medications, and tobacco products that may be present in oral fluid. Compounds were tested up to a concentration of 40,000 ng/mL. Results are summarized below.
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Structurally Related Compounds That Cross-React
| Compound | Concentration Equivalent to the cutoff (ng/mL) | Percent cross-reactivity |
| --- | --- | --- |
| Amitriptyline | 23,200 | 0.04% |
| (+) Brompheniramine | 24,100 | 0.04% |
| (+) Chlorphenamine | 24,800 | 0.04% |
| Chlorpromazine | 13,200 | 0.08% |
| Clomipramine | 18,300 | 0.05% |
| Cyclizine | 26,200 | 0.04% |
| Cyclobenzaprine | 23,100 | 0.04% |
| Dexbrompheniramine | 31,600 | 0.03% |
| Doxepin | 23,100 | 0.04% |
| 4-Hydroxy-PCP | 620 | 1.6% |
| Thioridazine | 10,100 | 0.1% |
| 1-(1-phenylcyclohexyl) morpholine (PCM) | 310 | 3.1% |
| EDDP | 20,200 | 0.5% |
| Imipramine | 22,200 | 0.05% |
| Prazepam | 14,200 | 0.07% |
Structurally Related Compounds That Do Not Cross React
No cross-reactivity was observed with the following structurally related compounds when tested up to a concentration of 30,000 ng/mL.
| O-Desmethylvenlafaxine |
| --- |
| Dextromethorphan |
| Diphenhydramine |
| Doxylamine |
| Ketamine |
| Venlafaxine |
Potential interference from structurally unrelated compounds was tested by spiking the potentially interfering compound into human oral fluid drug controls having drug concentration at +/-50 % of the cutoff.
All were tested at a concentration of 30,000 ng/mL. No negative or positive interference was seen in this study.
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| Compound | | Clobazam | | 1-Methamphetamine |
| --- | --- | --- | --- | --- |
| | | Clonazepam | | Loperamide |
| | | Clorazepate | | Lorazepam |
| Cotinine | | Cocaethylene | | 1-Phenylalanine |
| (-) Ephedrine | | Cocaine | | 1-Phenylephrine |
| (-) Epinephrine | | Codeine | | LSD |
| (+) Naproxen | | Creatine | | Maprotiline |
| (+/-) Chlorpheniramine | | d-Amphetamine | | MBDB |
| (+/-) Epinephrine | | d-Ephedrine | | MDA |
| Isoprenaline | | Desipramine | | MDE |
| (+/-) Methadone | | D-Glucose | | MDEA |
| (+/-) Pseudoephedrine | | Diacetylmorphine (Heroin) | | MDMA |
| (R, 2R) Pseudoephedrine | | Diazepam | | Medazepam |
| 11-Hydroxy-Δ-9-THC | | Dihydrocodeine | | Meperidine |
| 4-Aminophenylsulfone | | Diphenylhydantoin | | Mephentermine |
| 4-Dimethylaminoantipyrine | | d-Methamphetamine | | Methadol |
| 6-Monoacetylmorphine | | Dopamine | | Methaqualone |
| Acetaminophen | | d-Propoxyphene | | Methylphenidate |
| Acetylsalicylic acid | | Ecgonine | | Morphine |
| Alprazolam | | Ecgonine methyl ester | | Morphine-3 DG |
| Amobarbital | | | | Nalorphine |
| Ampicillin | | Erythromycin | | Naloxone |
| Aprobarbital | | Ethylmorphine | | Naltrexone |
| Ascorbic acid | | Fenfluramine | | Niacinamide |
| Aspartame | | Fenoprofen | | Nicotine |
| Atropine | | Fentanyl | | Nitrazepam |
| Benzodioxolylbutanamine | | Flunitrazepam | | N-Methylephedrine |
| Benzocaine | | Fluoxetine | | Norcocaine |
| Benzoylecgonine | | Flurazepam | | Nordiazepam |
| Phenethylamine | | Furosemide | | Norketamine |
| Bromazepam | | Gentisic Acid | | Normorphine |
| Buprenorphine | | Glipizide | | Norpropoxyphene |
| Butabarbital | | Guaiacol glycerol | | Nortriptyline |
| Butalbital | | Hydrocodone | | O-Desmethylvenlafaxine |
| Caffeine | | Hydromorphone | | Oxalic acid |
| Cannabidiol | | Ibuprofen | | Oxazepam |
| Cannabinol | | Isoxsuprine | | Oxycodone |
| Carbamazepine | | 1-Amphetamine | | Oxymorphone |
| Chlordiazepoxide | | Levorphanol | | Pantoprazole |
| Chloroquine | | Lidocaine | | Penicillin G |
| Chlorothiazide | | | | |
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| Pentazocine | | Procaine | | Triazolam |
| --- | --- | --- | --- | --- |
| Pentobarbital | | Procainamide | | Trifluoperazine |
| Perphenazine | | Promethazine | | Trimethobenzamide |
| Phencyclidine | | Protriptyline | | Trimipramine |
| Phendimetrazine | | Pseudoephedrine | | Tyramine |
| Pheniramine | | Quetiapine | | Δ-8-THC |
| Phenobarbital | | Quinidine | | Δ-9-THC |
| Phenothiazine | | Ranitidine | | Δ-9-THC acid |
| Phentermine | | Rifampin | | Buproprion |
| Phenylpropanolamine | | Secobarbital | | Hydroxy-buproprion |
| PMA | | Sulindac | | Dihydrobupropion |
| PMMA | | Theophylline | | |
| Primidone | | Tramadol | | |
The sponsor also evaluated the effect of endogenous substances, pH, and food, drinks, medications, and tobacco products that may be present in oral fluid samples. These were spiked at the concentrations listed below into human oral fluid drug controls having drug concentration at $+/-50\%$ of the cutoff. No negative or positive interference was seen in this study.
| Compound Name | Neat Oral Fluid Concentration |
| --- | --- |
| Human Serum Albumin (HSA) | 1.0 mg/mL |
| Alcohol (Ethanol) | 1% v/v |
| Baking Soda | 6% w/v |
| Whole Blood | 0.4% v/v |
| Hemoglobin | 0.5 mg/mL |
| Hydrogen Peroxide, OTC (3%) | 6% v/v |
| Sodium Chloride | 18 ng/mL |
| pH 5, 6, 7, 8, 9 | N/A |
| Cholesterol | 45 ng/mL |
| Denture Adhesive | 0.6% w/v |
| Ascorbic Acid | 1 mg/mL |
| Bilirubin | 150 ug/mL |
| IgA | 0.1 mg/mL |
| IgG | 0.5 mg/mL |
| IgM | 0.1 mg/mL |
| Antiseptic Mouthwash | 1 oz. |
| Cough Syrup | 1 teaspoon |
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| Compound Name | Neat Oral Fluid Concentration |
| --- | --- |
| Cranberry Juice | 6 oz. |
| Orange Juice | 6 oz. |
| Tooth Paste | 1 gram |
| Chewing Tobacco | 1 gram |
| Cigarettes | 1 cigarette |
| Chewing Gum | 1 piece |
| Hard Candy | 1 piece |
| Teeth Whitening Strips | 2 strips |
| Cola | 12 oz. |
| Water | 6 oz. |
| Antacid | 2 x 500 mg tablets |
| Coffee | 8 oz. |
| Tea | 8 oz. |
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.
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:
The sponsor performed a method comparison study with 246 oral fluid samples with concentrations ranging from 0 – 18, 915 ng/mL PCP. Because of the difficulty in finding native near-cutoff samples, 15 of the 246 samples were prepared by diluting a high concentration sample. Each of the diluted samples was made from a single dilution of a unique high concentration sample. Results are summarized below:
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| | Negative by the predicate device or less than half the cutoff concentration by GC/MS analysis | 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 | 1* | 11 | 107 |
| Negative | 114 | 13 | 0 | 0 |
* The concentration of PCP in this sample was 9 ng/mL as measured by GC/MS
Agreement among positives is 100% (118/118)
Agreement among negatives is 99% (127/128)
b. Matrix comparison:
Not applicable. Oral fluid is the only acceptable matrix.
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):
Not applicable.
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
N. Instrument Name:
RapidFRET Integrated Workstation instrument
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O. System Descriptions:
1. Modes of Operation:
RapidFRET Integrated Workstation instrument
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐
3. Specimen Identification:
Oral fluid samples may be identified by a barcode on the sample container. The barcode may be scanned or entered manually.
4. Specimen Sampling and Handling:
Prior to sample collection, individuals should rinse their mouth with at least 2 oz. of water and wait a minimum of 10 minutes before initiation of sample collection. Neat oral fluid specimens are collected directly into the RapidEASE® Oral Fluid Collector. Samples should be shipped for analysis as soon as possible following collection, preferably within 24 hours.
Samples should be at room temperature before testing. Sample fluid volume should meet or exceed the “Adequate Fill Volume Line” when the sample vial is held upright (approximately 2.0 mL). Low volume samples should not be used. Sample tubes containing excess sample volume (greater than Max Fill indicator line, approximately half of tube volume) should not be run directly on the RapidFRET Integrated Workstation instrument. Excess volume should be decanted or pipetted off prior to analysis.
5. Calibration:
The labeling directs the user to calibrate with each microtiter plate. Controls and patient samples are interpreted as positive or negative depending upon whether they read above or below the 10 ng/mL cutoff calibrator.
6. Quality Control:
Positive and negative controls are provided at -50% and +50% of the cutoff (5 ng/mL and 15 ng/mL). Users are instructed to follow the appropriate federal, state and local guidelines concerning the running of external quality controls.
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P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
Not applicable.
Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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