(88 days)
Not Found
No
The summary describes a standard immunoassay technology and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic assay used for the quantitative determination of Procalcitonin levels, which aids in risk assessment and decision-making for antibiotic therapy. It does not directly treat or prevent a disease.
Yes
The device quantitatively determines Procalcitonin levels in human serum and plasma, which is explicitly stated to "aid in the risk assessment," "aid in assessing cumulative 28-day risk," and "aid in decision making on antibiotic therapy and discontinuation" for specific medical conditions. These uses directly support medical diagnosis and treatment decisions.
No
The device is an in vitro diagnostic (IVD) assay that uses chemiluminescence immunoassay technology and is performed on a LIAISON® Analyzer, which is a hardware instrument. The description details the chemical reactions and physical components involved in the assay.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "in vitro quantitative determination of Procalcitonin in human serum and lithium heparin plasma specimens." The term "in vitro" is a key indicator of an IVD.
- Specimen Type: The assay analyzes human serum and plasma specimens, which are biological samples taken from the body but tested outside of it.
- Purpose: The assay is used to aid in clinical decision-making regarding sepsis and antibiotic therapy, which are diagnostic purposes.
- Device Description: The description details a laboratory-based immunoassay method using chemical reactions to measure a substance in a sample.
- Performance Studies: The document includes details of performance studies like method comparison, reproducibility, and sample stability, which are standard for IVD devices to demonstrate their analytical performance.
- Quality Control: The mention of quality control samples (LIAISON® Control B.R.A.H.M.S PCT® II GEN) and calibration verifiers further confirms its use in a laboratory setting for diagnostic testing.
- Predicate Device: The mention of a predicate device (VIDAS® B-R-A-H·M·S PCT™) with a K number (K162827) indicates that this device is being compared to a previously cleared IVD.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LIAISON® B.R.A.H.M.S PCT® II GEN assay uses chemiluminescence immunoassay (CLIA) technology for the in vitro quantitative determination of Procalcitonin in human serum and lithium heparin plasma specimens. Used in conjunction with other laboratory findings and clinical assessments, LIAISON® B.R.A.H.M.S.PCT® II GEN 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 sepsic 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 (LRT) 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 LIAISON® Control B.R.A.H.M.S PCT® II GEN (level 1 and level 2) are intended for use as assayed quality control samples to monitor the performance and reliability of the LIAISON® BRAHMS PCT® II GEN assay. The performance characteristics of LIAISON® BRAHMS PCT® II GEN controls have not been established with any other assay or instrument platform different from the LIAISON® Analyzer.
The LIAISON® B.R.A.H.M.S PCT® II GEN Verifiers (four levels) are assayed quality control materials intended in the quantitative verification of calibration and reportable range of the LIAISON® BRAHMS PCT® II GEN assay. The performance characteristics of LIAISON® BRAHMS PCT® II GEN calibration verifiers have not been established in connection with any other assay or instrument platforms different from the LIAISON® Analyzer.
Product codes (comma separated list FDA assigned to the subject device)
PMT, NTM, JJX, PRI
Device Description
The method for the quantitative determination of PCT is a sandwich chemiluminescence immunoassav. A specific monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody (specific for a different epitope of the procalcitonin molecule) is linked to an isoluminol derivative (isoluminol-antibody conjugate).
During the first incubation, PCT present in calibrators, samples or controls binds to the antibody conjugate. Then the solid phase is added to the reaction. A sandwich is formed only in the presence of PCT molecules that bridge both antibodies. After the second incubation, the unbound material is removed with a wash cycle.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminolantibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of PCT concentration present in calibrators, samples or controls.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Limit of Blank (LoB)
The limit of blank for the LIAISON® BRAHMS PCT® II GEN assay is 0.01 ng/mL.
Limit of Detection (LoD)
The limit of detection for the LIAISON® BRAHMS PCT® II GEN assay is 0.02 ng/mL.
Limit of Quantification (LoQ)
The limit of quantitation for the LIAISON® BRAHMS PCT® II GEN assay is 0.05 ng/mL ( %Bias 100 ng/mL on the LIAISON® BRAHMS PCT® II GEN assay.
The PCT sample results ranged from 0.05 ng/mL to 131 ng/mL.
Weighted Deming analysis yielded agreement of y = 1.07x + 0.03. The 95% confidence intervals for the slope were 1.03 to 1.11 and for the intercept 0.02 to 0.05 ng/mL.
A qualitative method comparison study was also performed on the 369 samples. Results are provided in an agreement table for the following cut-offs: a.) 0.10 and 0.25 and = 0.5 and = 2.0.
Reproducibility/Precision:
Internal 20-day Precision
A twenty day reproducibility/precision study was performed internally at DiaSorin Inc.
A coded panel comprised of 10 frozen serum samples spanning the assay range was prepared. One lot of LIAISON® Control BRAHMS PCT® II GEN (2 levels) and one lot of LIAISON® BRAHMS PCT® II GEN verifiers (4 levels) were also tested.
Samples, kit controls, and verifiers were tested on two lots of LIAISON® BRAHMS PCT® II GEN in two replicates per run, 2 runs per day for 20 operating days on 1 LIAISON® Analyzer with multiple operators.
Multi-Site Precision
A five day precision/reproducibility study was performed at two external laboratories and internally at DiaSorin Inc.
A coded panel comprised of 10 frozen serum samples spanning the assay range was prepared. Two lots of LIAISON® Control BRAHMS PCT® II GEN (2 levels) and two lots of LIAISON® BRAHMS PCT® II GEN verifiers (4 levels) were also tested.
Samples, kit controls, and verifiers were tested on one lot of LIAISON® BRAHMS PCT® II GEN in three replicates per run, 2 runs per day for 5 operating days on 3 LIAISON® Analyzers with multiple operators.
Sample Equivalence and Stability Studies:
Equivalence testing was performed with 40 matched patient samples consisting of serum and lithium heparin collection tubes. Samples spanned the full assay measuring range, using spiked or diluted samples.
Paired samples were tested in triplicate in the same run using 1 reagent lot and 1 analyzer.
Results were compared by Passing and Bablok and Weighted Deming regression. Human serum and Lithium Heparin Plasma are acceptable sample types.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Limit of Quantification (LoQ)
%Bias
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2018
DiaSorin Inc. Carol A DePouw Regulatory Affairs Specialist 1951 Northwestern Ave. Stillwater, MN 55082-0285 US
Re: K173683
Trade/Device Name: LIAISON BRAHMS PCT II GEN assay, LIAISON Control BRAHMS PCT II GEN and LIAISON BRAHMS PCT II GEN Verifiers 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: II Product Code: PMT, NTM, JJX Dated: November 30, 2017 Received: December 1, 2017
Dear Ms. DePouw:
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. 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.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Steven R. Gitterman -S for
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
LIAISON® B.R.A.H.M.S PCT® II Gen LIAISON® Control B.R.A.H.M.S PCT® II Gen LIAISON® B.R.A.H.M.S PCT® II Gen Verifiers
Indications for Use (Describe)
The LIAISON® B.R.A.H.M.S PCT® II GEN assay uses chemiluminescence immunoassay (CLIA) technology for the in vitro quantitative determination of Procalcitonin in human serum and lithium heparin plasma specimens. Used in conjunction with other laboratory findings and clinical assessments, LIAISON® B.R.A.H.M.S.PCT® II GEN 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 sepsic 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 (LRT) 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 LIAISON® Control B.R.A.H.M.S PCT® II GEN (level 1 and level 2) are intended for use as assayed quality control samples to monitor the performance and reliability of the LIAISON® BRAHMS PCT® II GEN assay. The performance characteristics of LIAISON® BRAHMS PCT® II GEN controls have not been established with any other assay or instrument platform different from the LIAISON® Analyzer.
The LIAISON® B.R.A.H.M.S PCT® II GEN Verifiers (four levels) are assayed quality control materials intended in the quantitative verification of calibration and reportable range of the LIAISON® BRAHMS PCT® II GEN assay. The performance characteristics of LIAISON® BRAHMS PCT® II GEN calibration verifiers have not been established in connection with any other assay or instrument platforms different from the LIAISON® Analyzer.
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) |
|---|
| ------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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5.0 510(k) SUMMARY
| SUBMITTED BY: | Carol A. DePouw
Regulatory Affairs Specialist
DiaSorin Inc.
1951 Northwestern Avenue
Stillwater, MN 55082-0285
Phone (651) 351-5850
Fax (651) 351-5669
Email: carol.depouw@diasorin.com |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® BRAHMS PCT® II GEN,
LIAISON® Control BRAHMS PCT® II GEN
LIAISON® BRAHMS PCT® II GEN Verifiers |
| Common Names/Descriptions: | Procalcitonin Assay |
| Classification Names: | Device to detect and measure non microbial
analyte(s) in human clinical specimens to aid in
assessment of patients with suspected sepsis
21 CFR 866.3215 (PMT)
Procalcitonin Assay 21 CFR 866.3215(PRI) |
| Product Code: | PRI, PMT, NTM, JJX |
| PREDICATE DEVICES: | VIDAS® B-R-A-H·M·S PCT™ (K162827) |
DEVICE DESCRIPTION:
INTENDED USE:
LIAISON® BRAHMS PCT® II GEN assay uses chemiluminescence immunoassay (CLIA) technology for the in vitro quantitative determination of Procalcitonin in human serum and lithium heparin plasma specimens. Used in conjunction with other laboratory findings and clinical assessments, LIAISON® BRAHMS PCT® II GEN 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,
5
- to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.
The LIAISON® Control BRAHMS PCT® (level 1 and level 2) are intended for use as assayed quality control samples to monitor the performance and reliability of the LIAISON® BRAHMS PCT® II GEN assay. The performance characteristics of LIAISON® BRAHMS PCT® II GEN controls have not been established with any other assay or instrument platform different from the LIAISON® Analyzer.
The LIAISON® BRAHMS PCT® II GEN calibration verifiers (four levels) are assayed quality control materials intended in the quantitative verification of calibration and reportable range of the LIAISON® BRAHMS PCT® II GEN assay. The performance characteristics of LIAISON® BRAHMS PCT® II GEN calibration verifiers have not been established in connection with any other assay or instrument platforms different from the LIAISON® Analyzer.
KIT DESCRIPTION:
The method for the quantitative determination of PCT is a sandwich chemiluminescence immunoassav. A specific monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody (specific for a different epitope of the procalcitonin molecule) is linked to an isoluminol derivative (isoluminol-antibody conjugate).
During the first incubation, PCT present in calibrators, samples or controls binds to the antibody conjugate. Then the solid phase is added to the reaction. A sandwich is formed only in the presence of PCT molecules that bridge both antibodies. After the second incubation, the unbound material is removed with a wash cycle.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminolantibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of PCT concentration present in calibrators, samples or controls.
6
7
| Sample Matrix | Serum and Lithium Heparin | Serum and Lithium Heparin | ||||||
|---|---|---|---|---|---|---|---|---|
| Calibrators | Two | Two | ||||||
| Controls | Two (Low and High) | Two (Low and High) | ||||||
| Reagent Storage | 2-8°C, Refrigerator | 2-8°C onboard or in Refrigerator |
| Table 2: | Table of Differences | |
|---|---|---|
| Characteristic | Predicate Device: | |
| VIDAS® BRAHMS PCT™ | ||
| (K162827) | Candidate Device: | |
| LIAISON® BRAHMS PCT® II GEN | ||
| (K173683) | ||
| Type of Assay | Enzyme Immunoassay | Chemiluminescent Immunoassay |
| Detection | ELFA - Enzyme-Linked | |
| Fluorescent Assay | CLIA - Chemiluminescence | |
| Immunoassay | ||
| Sample | ||
| Handling/processing | Manual | Automated |
| Detector | Alkaline phosphatase-labeled | |
| mouse monoclonal anti-human | ||
| procalcitonin immunoglobulins | Anti-calcitonin antibody, labelled | |
| with isoluminol, monoclonal | ||
| (mouse) | ||
| Capture Reagent | Microwells coated with mouse | |
| monoclonal anti-human | ||
| procalcitonin immunoglobulins | Magnetic particles coated with | |
| anti-katacalcin antibody, | ||
| monoclonal (mouse) | ||
| Sample Volume | 200 µL | 225 µL specimen |
| (75 µL specimen + 150 µL dead | ||
| volume) | ||
| Measurement | ||
| System | Spectrophotometer | |
| (EIA Microtiter plate reader) | Photomultiplier | |
| (flash chemiluminescence reader) | ||
| Total incubation | 20 minutes | 40 minutes |
| Table 3: Control Similarities and Differences | ||
|---|---|---|
| Characteristics | Predicate Device: | |
| VIDAS® BRAHMS | ||
| (K162827) | Candidate Device: | |
| LIAISON® Controls BRAHMS | ||
| PCT® II GEN (K173683) | ||
| Intended Use | Intended for use as assayed quality control samples to monitor the performance of the LIAISON® BRAHMS PCT II GEN assay | Same |
| Matrix | Recombinant human PCT | Recombinant Antigen Procalcitonin |
| Storage | 2-8°C | Same |
| Quantity and | ||
| Volume | 2 x 2 mL (lyophilized) | 2 x 1.1 mL (lyophilized) |
8
| Table 4: Calibration Verifiers Similarities and Differences | ||
|---|---|---|
| Characteristic | Predicate Device | |
| (K141463) - LIAISON® XL | ||
| 1,25 Dihydroxyvitamin D | ||
| Calibration Verifiers | Candidate Device | |
| LIAISON® BRAHMS PCT® | ||
| II GEN Verifiers (K173683) | ||
| Intended Use | Assayed quality control materials | |
| intended for the quantitative | ||
| verification of calibration and | ||
| reportable range of the LIAISON® | ||
| XL 1,25 Dihydroxyvitamin D | Assayed quality control | |
| materials intended in the | ||
| quantitative verification of | ||
| calibration and reportable | ||
| range of the LIAISON® | ||
| BRAHMS PCT® II GEN assay. | ||
| Product Storage | 2 to 8°C until ready to use | Same |
| Levels | 4 levels; lyophilized | Same |
| Volume | 2.0 mLs | 1.1 mLs |
PERFORMANCE DATA:
Limit of Blank (LoB)*
Following the method from CLSI EP17-A2, the limit of blank for the LIAISON® BRAHMS PCT® II GEN assay is 0.01 ng/mL.
*Limit of Blank, or the highest value likely to be observed with a sample containing no analyte, replaces the term "analytical sensitivity".
Limit of Detection (LoD)
Following the method from CLSI EP17-A2, the limit of detection for the LIAISON® BRAHMS PCT® II GEN assay is 0.02 ng/mL.
Limit of Quantification (LoQ)
Following the method from CLSI EP17-A2, the limit of quantitation for the LIAISON® BRAHMS PCT® II GEN assay is 0.05 ng/mL ( %Bias 100 ng/mL on the LIAISON® BRAHMS PCT® II GEN assay and therefore was also removed from the analysis.
The PCT sample results ranged from 0.05 ng/mL to 131 ng/mL.
Weighted Deming analysis was applied to the results across the range of the LIAISON® BRAHMS PCT® II GEN assay yielding agreement of y = 1.07x + 0.03. The 95% confidence intervals for the slope were 1.03 to 1.11 and the 95% confidence intervals for the intercept 0.02 to 0.05 ng/mL.
| Table 5: Bias calculated at two medical decision points 0.50 and 2.0 ng mL with 95% Cl | |||
|---|---|---|---|
| Decision level | Bias | 95% CI | Bias Calculation |
| 0.5 | 0.06481 | 0.05021 to 0.07941 | 13% |
| 2 | 0.16588 | 0.09894 to 0.23283 | 8% |
Qualitative Analysis Study Design - Agreement at Clinical Decision Points
A qualitative method comparison study was also performed on the 369 samples. Results for the LIAISON® BRAHMS PCT® II GEN assay are provided in an agreement table and confidence intervals for each level within a comparison table for the following cut-offs:
| a.) ≤ 0.10; | b.) > 0.10 and ≤ 0.25; | c.) > 0.25 and 0.10 and ≤ 0.25 ng/mL | >0.25 and 0.10 and ≤ 0.25 ng/mL | 17 | 31 | 3 | 0 | 0 | 51 |
| >0.25 and