(96 days)
Not Found
No
The summary describes a standard immunoassay for measuring procalcitonin levels and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
This device is an immunoassay for the quantitative determination of procalcitonin levels, which aids in risk assessment, but it does not directly treat or prevent a disease.
Yes
Explanation: The Access PCT assay is explicitly described as aiding in the "risk assessment of critically ill patients on their first day of ICU admission to severe sepsis and septic shock" by quantifying procalcitonin levels. This risk assessment directly contributes to diagnosis and patient management.
No
The device description clearly outlines physical reagents (paramagnetic particles, buffers, etc.) used in a chemiluminescent immunoassay, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is for "in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma". This clearly indicates it is used to test samples taken from the human body outside of the body.
- Device Description: The description details the components of the "Access PCT assay," which are reagents used in a laboratory setting to perform the test.
- Performance Studies: The document describes various performance studies (Method Comparison, Imprecision, Linearity, etc.) conducted on human samples (serum and plasma) to validate the assay's performance.
- Intended User/Care Setting: The intended users and settings (laboratory, ICU, emergency department) are consistent with the use of an in vitro diagnostic device.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K162827) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
N/A
Intended Use / Indications for Use
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission to severe sepsis and septic shock.
The Access PCT Calibrators are intended to calibrate the Access PCT assay for the quantitative determination of procalcitonin levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems.
Product codes (comma separated list FDA assigned to the subject device)
PTF
Device Description
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission for progressive to severe sepsis and septic shock.
A description of the reagent pack is provided below.
- R1a: Dynabeads* paramagnetic particles coated with mouse anti-human Procalcitonin monoclonal antibody in a TRIS buffer with surfactant, protein (bovine), = 0.95.
Imprecision: The Access PCT assay exhibits total imprecision of = 0.150 ng/mL, and standard deviation (SD) = 0.150 ng/mL, and a standard deviation (SD) = 21 years of age, that were not experiencing an acute bacterial or viral illness. The established Reference Interval (RI) is consistent with commonly used reference intervals for apparently healthy individuals of PCT
§ 866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
(a)
Identification. A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the device's detailed Indications for Use statement describing what the device detects and measures, the results provided to the user, whether the measure is qualitative and/or quantitative, the clinical indications for which the test is to be used, and the specific population(s) for which the device use is intended.
(2) Premarket notification submissions must include detailed documentation of the device description, including (as applicable), all device components, software, ancillary reagents required but not provided, explanation of the device principle and methodology, and for molecular devices include detailed documentation of the primer/probe sequence, design, and rationale for sequence selection.
(3) Premarket notification submissions must include detailed documentation of applicable analytical studies, such as, analytical sensitivity (Limit of Detection, Limit of Blank, and Limit of Quantitation), precision, reproducibility, analytical measuring range, interference, cross-reactivity, and specimen stability.
(4) Premarket notification submissions must include detailed documentation of a prospective clinical study or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information:
(i) Results must demonstrate adequate device performance relative to a well-accepted comparator.
(ii) Clinical sample results must demonstrate consistency of device output throughout the device measuring range likely to be encountered in the Intended Use population.
(iii) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the Indications for Use(s), and results of all statistical analyses.
(5) Premarket notification submissions must include evaluation of the level of the non-microbial analyte in asymptomatic patients with demographic characteristics (
e.g., age, racial, ethnic, and gender distribution) similar to the Intended Use population.(6) As part of the risk management activities performed under 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
(7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling, and a detailed explanation of the interpretation of the limitations of the samples (
e.g., collected on day of diagnosis) must be included in the device's 21 CFR 809.10(b)(10) compliant labeling.
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November 26, 2019
Beckman Coulter, Inc. Jennifer Bennett Staff Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
Re: K192271
Trade/Device Name: Access PCT, Access PCT Calibrators Regulation Number: 21 CFR 866.3215 Regulation Name: Device To Detect And Measure Non-Microbial Analyte(S) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis Regulatory Class: Class II Product Code: PTF Dated: August 21, 2019 Received: August 22, 2019
Dear Jennifer Bennett:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kristian Roth, Ph.D. Branch Chief Bacterial Multiplex and Medical Counter Measures Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K192271
Device Name Access PCT, Access PCT calibrators
Indications for Use (Describe)
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission to severe sepsis and septic shock.
The Access PCT Calibrators are intended to calibrate the Access PCT assay for the quantitative determination of procalcitonin levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Access PCT 510(K) Summary
Immunodiagnostic Development Center
1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a)(1).
The assigned 510(k) number is
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1142 Fax: (952) 368-7610
Contact Person:
Jennifer Bennett 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-2040 Fax: (952) 368-7704
Alternate Contact: Kerrie Oetter
(952) 368-7858 (952) 368-7704 (fax)
Date Prepared:
August 22, 2019 November 18, 2019 (Updated)
Device Name:
Proprietary / Trade Name: Access PCT Reagent Common Name: Procalcitonin Immunoassay Classification Name: Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis Classification Regulation: 21 CFR 866.3215 Classification Product Code: PTF
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Predicate Device:
The Access PCT Reagent claims substantial equivalence to the VIDAS® B-R-A-H-M-S PCT®† assay kit by Biomerieux, FDA 510(k) Number K162827, cleared May 31, 2017.
Device Description:
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission for progressive to severe sepsis and septic shock.
A description of the reagent pack is provided below.
- R1a: Dynabeads* paramagnetic particles coated with mouse anti-human ● Procalcitonin monoclonal antibody in a TRIS buffer with surfactant, protein (bovine), ≤ 0.1% sodium azide, and 0.1% ProClin**300
- R1b: 0.10 N Sodium Hvdroxide ●
- R1c: MOPS Buffer with surfactant and protein (bovine, murine). ≤ 0.1% . sodium azide, and 0.1% ProClin 300
- R1d: Rat anti-Procalcitonin recombinant alkaline phosphatase conjugate in a ● MOPS buffer with surfactant and protein (bovine, murine, recombinant), ≤ 0.1% sodium azide, and 0.1% ProClin 300 *Dynabead® is a registered trademark of Dynal A.S., Oslo, Norway **ProClin™ is a trademark of The Dow Chemical Company ("Dow") or an affiliate company of Dow.
Intended Use:
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock.
Comparison to the Predicates:
The Access PCT Assay and the predicate device, VIDAS® B·R·A·H·M·S PCT®T assay (K162827), were compared. The information for the predicate device was derived from the predicate device 510(k) Summary and product labeling.
† VIDAS® is a registered trademark of bioMérieux SA. B·R·H·M·S PCT® is a registered trademark of B·R·A·H·M·S GmbH.
5
| | Predicate Device
VIDAS® B·R·A·H·M·S PCT®†
K162827 | Proposed Device
Access PCT Assay on Access
2 Immunoassay System |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | VIDAS® B·R·A·H·M·S PCT®† (PCT) is an automated test for use on the
instruments of the VIDAS family for the determination of human
procalcitonin in human serum or plasma (lithium heparinate) using
the ELFA (Enzyme-Linked
Fluorescent Assay) technique.
Used in conjunction with other laboratory findings and clinical
assessments, VIDAS® B•R•A•H•M•S PCT®† is intended for use as
follows: · to aid in the risk
assessment of critically ill patients on their first day of ICU admission for
progression to severe sepsis and septic shock, · to aid in assessing
the cumulative 28-day risk of all- cause mortality for patients
diagnosed with severe sepsis or septic shock in the ICU or when
obtained in the emergency department or other medical wards
prior to ICU admission, using a
change in PCT level over time, · to aid in decision making on antibiotic
therapy for patients with suspected or confirmed lower respiratory tract
infections (LRTI) defined as community-acquired pneumonia
(CAP), acute bronchitis, and acute exacerbation of chronic obstructive
pulmonary disease (AECOPD) – in an inpatient setting or an emergency
department, · to aid in decision making on antibiotic discontinuation
for patients with
suspected or confirmed sepsis. | The Access PCT assay is a paramagnetic, chemiluminescent
immunoassay for in vitro
quantitative determination of procalcitonin (PCT) levels in
human serum and plasma
(lithium heparin and EDTA)
using the Access Immunoassay
Systems. Measurement of PCT
in conjunction with other laboratory findings and clinical
assessments aids in the risk assessment of critically ill
patients on their first day of ICU
admission for progression to severe sepsis and septic shock. |
| Characteristic | Predicate Device
VIDAS® B-R-A-H-M-S PCT®†
K162827 | Proposed Device
Access PCT Assay on Access
2 Immunoassay System |
| Analyte
Measured | Procalcitonin (PCT) | Same |
| Sample Type | Human serum or plasma (lithium
heparinate) | Human Serum or Plasma (LiHep
and EDTA) |
| Method | Automated Assay | Same |
| Format | ELFA (Enzyme-Linked
Fluorescent Assay) technique | Chemiluminescent |
| Technology | Immunoassay based on sandwich
principle | Same |
| Primary
Reagent
Materials | Solid Phase: Mouse monoclonal
anti-procalcitonin
immunoglobins
coated on interior of the SPR
Conjugate: Alkaline phosphatase-
labeled mouse monoclonal anti-
human procalcitonin immunoglobins | Dynabeads* paramagnetic
particles coated with mouse
anti-human procalcitonin
monoclonal antibody |
| Assay
Duration | Approximately 20 minutes | Same |
| Sample
Volume | 200 µL | 35 µL |
| Measuring
Range | 0.05 ng/mL to 100 ng/mL | 0.05 ng/mL to 100 ng/mL |
| LoB | 0.01 ng/mL | 0.005 ng/mL |
| LoD | 0.03 ng/mL | 0.01 ng/mL |
| LoQ | 0.05 ng/mL | 0.02 ng/mL |
| Hook | No hook effect up to procalcitonin
concentrations of 2,600 ng/mL | No hook effect up to procalcitonin
concentrations of 5,000 ng/mL |
| Expected
Results (Upper
Reference
Limit) | 99th percentile 0.09 ng/ml 95th
percentile † VIDAS® is a registered trademark of bioMérieux SA. B·R·A·H·M·S PCT is a registered trademark of B·R·A·H·M·S GmbH.
6
*Dynabead® is a registered trademark of Dynal A.S., Oslo, Norway
† VIDAS® is a registered trademark of bioMérieux SA. B·R·A·H·M·S PCT® is a registered trademark of B·R·A·H·M·S GmbH.
7
Summary of Studies
Method Comparison: A comparison of approximately 207 serum samples with PCT concentrations ranging from approximately 0.05 ng/mL to 100 ng/mL were run on both the Access PCT assay and the predicate VIDAS® B-R-A-H-M-S PCT®+ assay. The results were compared using Passing-Bablok regression and Pearson correlation with the predicate on the x-axis. The observed linear fit had a slope = 0.96 with 95% confidence interval of 0.94 to 0.99, an intercept =
0.02 nq/mL and a correlation coefficient (r) = 0.99. The slope specification is set at 0.90 ± 0.10 with correlation coefficient (r) ≥ 0.95.
Imprecision: The Access PCT assay exhibits total imprecision of ≤ 8.0% CV at concentrations ≥ 0.150 ng/mL, and standard deviation (SD) ≤ 0.012 ng/mL at concentrations † VIDAS® is a registered trademark of bioMérieux SA. B·R·H·M·S PCT® is a registered trademark of B·R·A·H·M·S GmbH.
8
Limit of Blank (LoB):
The highest measurement result observed with no analyte present in a serum sample is ≤ 0.005 ng/mL.
Limit of Detection (LoD):
The limit of detection (LoD) for the Access PCT assay is ≤ 0.01 ng/mL.
Limit of Quantitation (LoQ): The limit of quantitation (LoQ) based on 20% within-laboratory imprecision for the Access PCT assay is ≤ 0.02 ng/mL.
Total Error: The LoQ was established using a 20% CV acceptance goal as recommended in CLSI guideline EP17-A2 for cases where no generally accepted reference standard is available. To supplement the within-laboratory %CV LoQ analysis, a modeling analysis was performed to estimate the Total Error at each clinical cutoff (0.5 ng/mL and 2.0 ng/mL). The slope and intercept estimates that were derived from the method comparison study were used to obtain estimates of bias and %bias at each concentration listed above. A precision profile model was fit to the estimated within-laboratory %CV values from the imprecision study samples with concentration values covering approximately 0.1 ng/mL to 8 ng/mL. Because the range of samples included in both the method comparison and the imprecision study cover the concentrations 0.1 ng/mL to 2.0 ng/mL, the bias estimates and precision profile estimates can be combined to provide an estimate of total error (TE) and %TE at each medical decision point.
The estimated %TE at the medical decision points 0.5 ng/mL and 2.0 ng/mL is ≤ 9.4% based on estimates from Weighted Deming regression and ≤ 11.3% from Passing Bablok regression.
| Concentration
| (ng/mL) | Bias (%) | CV (%) | Total Error (%) |
|---|---|---|---|
| 0.5 | 0.6% | 4.5% | 9.4% |
| 2 | 0.7% | 4.2% | 8.9% |
Percent Total Error Estimates Based on Bias Estimates Using Weighted Deming
9
| Concentration
| (ng/mL) | Bias (%) | CV (%) | Total Error (%) |
|---|---|---|---|
| 0.5 | -0.6% | 4.5% | 9.4% |
| 2 | -3.1% | 4.2% | 11.3% |
Percent Total Error Estimates Based on Bias Estimates Using Passing Bablok
Analytical Specificity: Potential cross-reactive substances were added to serum patient samples at three concentrations of procalcitonin (approximately
0.25 ng/mL, 0.5 ng/mL, and 2.0 ng/mL). Stock solutions of potential cross- reactants were prepared volumetrically using calibrated pipettes and the appropriate solvent. This stock solution was added directly to the serum in no more than 5% (v/v) final concentration. Control samples were prepared in the same manner using the solvent, without the crossreactant added. Control and test samples were tested on the Access 2 instrument within 24 hours of preparation, using three reagent lots. Testing of human calcitonin, human katacalcin, human alpha CGRP and human beta CGRP, with Access PCT found that there is no significant cross-reactivity, as defined by a change in concentration between the diluent control and the test samples within ± 10%. The acceptance criteria of ±10% was set to ensure that the potential for cross-reactivity is sufficiently mitigated while accommodating the expected imprecision of the assay when performing cross-reactivity testing.
Interfering Substances:
Known concentrations of potential interferents, as per CLSI EP07 (Interference Testing in Clinical Chemistry-Approved Guideline, Third Edition), were added to the patient samples. Results from these spiked test patient samples were evaluated against that of the unspiked control sample. In accordance with CLSI EP07, interference testing was completed on patient serum samples containing four levels of procalcitonin at three clinically relevant concentrations of 0.25 ng/mL, 0.5 ng/mL and 2.0 ng/mL and an additional procalcitonin concentration of approximately 80 ng/mL. See the interfering substance table below for the list of substances and interference concentrations tested.
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The study was run at an internal site on three Access 2 instruments, using three reagent pack lots and one calibrator lot. Five replicates were tested for each control sample and each spiked test sample preparation.
Of the substances tested, none were found to cause significant interference, as defined by a change in concentration between the diluent control and test sample within ± 10%. The acceptance criteria of ±10% was set to ensure that the potential for interference is sufficiently mitigated while accommodating the expected imprecision of the assay when performing interference testing.
| Substance | Interferent
Concentration Tested | Substance | Interferent
Concentration Tested |
|-----------------------------|-------------------------------------|--------------------------------|-------------------------------------|
| Acetaminophen | 20 mg/dL | Hemoglobin | 400 mg/dL |
| Acetylsalicylic Acid | 100 mg/dL | Heparin | 8000 IU/L |
| | 1.20 mg/dL | Human Serum
Albumin | 12 g/dL |
| Azithromycin | | Ibuprofen | 50 mg/dL |
| Bilirubin (Conjugated) | 40 mg/dL | | 18 mg/dL |
| Bilirubin
(Unconjugated) | 40 mg/dL | Imipenem | |
| Caffeine | 6.0 mg/dL | Levoflaxacin | 1.75 mg/dL |
| Cefotaxime/Cefotaxin | 90 mg/dL | Loratadine | 0.03 mg/dL |
| Celecoxib | 24 mg/dL | Naproxen | 50 mg/dL |
| Cetirizine HCL | 0.36 mg/dL | Nicotine | 0.1 mg/dL |
| Dextromethorphan | 0.14 mg/dL | Noradrenaline | 0.2 mg/dL |
| Dobutamine | 1.12 mg/dL | Oxymetazoline HCL | 0.009 mg/dL |
| Dopamine | 13 mg/dL | Phenylephrine | 0.018 mg/dL |
| Doxycycline | 5.0 mg/dL | Prednisolone | 0.3 mg/dL |
| Epinephrine
(adrenaline) | 0.18 mg/dL | Salmeterol | 0.006 mg/dL |
| Ethanol | 400 mg/dL | Theophylline | 10 mg/dL |
| Fentanyl | 1.0 mg/dL | Tiotropium | 0.0022 mg/dL |
| | 5.98 mg/dL | Triglycerides
(Intralipids) | 3000 mg/dL |
| Furosemide | | | |
Interfering Substances
Expected Reference Intervals: Samples were prospectively procured from two hundred and two (202), apparently healthy individuals ≥ 21 years of age, that were not experiencing an acute bacterial or viral illness. The established Reference Interval (RI) is consistent with commonly used reference intervals for apparently healthy individuals of PCT ≤ 0.1 ng/mL.
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| PCT Sample Statistics | |||
|---|---|---|---|
| Number of | |||
| Subjects | Median | ||
| ng/mL | 95th Percentile | ||
| Upper Reference Range | 95% Nonparametric Cl | ||
| of 95th percentile | |||
| Reference Range | |||
| 202 | 0.025 | 0.065 ng/mL | [0.054 - 0.085 ng/mL] |
Matrix Comparison: A comparison of forty-three (43) matched sets of serum gel, serum no gel, plasma lithium heparin, and plasma EDTA samples with procalcitonin concentrations ranging from approximately 0.19 to 86 ng/mL were compared using Passing-Bablok linear regression analysis.
The observed linear fit for serum (gel) vs. serum (no gel) had an estimated slope = 0.99 with a 95% confidence interval (CI) of 0.98 to 1.00. The observed linear fit for lithium heparin plasma vs. serum (no gel) had an estimated slope = 0.96 with a 95% Cl of 0.95 to 0.97. The observed linear fit for EDTA plasma vs. serum (no gel) had an estimated slope of 1.03, with a 95% Cl of 1.01 to 1.04. The observed linear fit for lithium heparin plasma vs. serum gel had an estimated slope of 0.97 with a 95% Cl of 0.96 to 0.99. The observed linear fit of EDTA plasma vs. serum gel had an estimated slope = 1.04 with a 95% Cl of 1.03 to 1.05. The observed linear fit of EDTA plasma vs. lithium heparin plasma had an estimated slope
= 1.06 with a 95% CI of 1.05 to 1.08.
Carryover Study: The PCT assay utilizes a sodium hydroxide wash between tests to mitigate the potential occurrence of carryover. Based on the expectation that carryover is minimized by this design feature, the acceptance criteria of ±10% was set to ensure that the potential for carryover is sufficiently mitigated while accommodating the expected imprecision of the assay when performing carryover testing.
Verification studies were performed to determine potential assay carryover for the Access PCT assay on the Access 2 instrument. The test used samples at 0.25 ng/mL and the medical decision points of 0.5 ng/mL and 2.0 ng/mL. Testing alternated low samples with high samples for each level tested and used a serum sample spiked with antigen and the highest calibrator. Testing met result criteria as all results had a shift of ≤ 10% for assay carryover.
Individual estimates of carryover ranged from -6% to +8% and indicate no clear trend of positive or negative shifts. This observation provides additional evidence that the potential
12
for carryover is sufficiently mitigated. If carryover of a high sample into a lower sample were present, we would expect to observe a positive bias only.
Conclusion:
The Access PCT assay is substantially equivalent to the currently marketed VIDAS® B•R•A•H•M•S PCT®† assay (K162827). The verification and validation data provided in this submission demonstrates that the safety and efficacy of this device is substantially equivalent to the predicate device.
† VIDAS® is a registered trademark of bioMérieux SA. B·R·H·M·S PCT® is a registered trademark of B·R·A·H·M·S GmbH.