(160 days)
No
The summary describes a standard immunoassay technology and its performance characteristics. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an immunoassay for the in vitro quantitative determination of PCT, used to aid in risk assessment and decision-making for antibiotic therapy, not to directly treat a condition.
Yes
The device quantitatively determines PCT levels to aid in risk assessment for sepsis, assess mortality risk, and guide antibiotic therapy decisions, all of which are diagnostic functions.
No
The device is an immunoassay that requires a physical analyzer (Elecsys and cobas e immunoassay analyzers) to perform the test and detect the signal. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma...". The phrase "in vitro" is a key indicator of an IVD.
- Sample Type: The device analyzes human serum and plasma, which are biological samples taken from the body but tested outside of it.
- Purpose: The intended uses are for aiding in risk assessment, assessing mortality risk, and aiding in decision making on antibiotic therapy, all of which are diagnostic purposes based on the analysis of biological samples.
- Device Description: The description details a laboratory-based immunoassay system (electrochemiluminescence immunoassay) used on specific analyzers (Elecsys and cobas e), which is typical of IVD devices.
- Performance Studies: The document describes various performance studies (precision, interference, specificity, method comparison) that are standard for evaluating the analytical and clinical performance of IVD devices.
- Predicate Device: The mention of a predicate device (K173927; Elecsys BRAHMS PCT) is common in regulatory submissions for IVDs, indicating a comparison to an already cleared IVD.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Used in conjunction with other laboratory findings and clinical assessments, Elecsys 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 determine the change in PCT level over time as an 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,
· to aid in decision making on antibiotic therapy, for inpatients in the emergency department 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),
· to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.
Product codes (comma separated list FDA assigned to the subject device)
PRI, PMT, NTM
Device Description
The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. An optional Procalcitonin CalCheck product is also available.
The reagent working solutions include:
Rackpack (kit placed on analyzer)
• M: Streptavidin-coated microparticles,
• R1: Anti-PCT-Abbiotin
• R2: Anti-PCT-AbRu(bpy)32+
The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay. Briefly, Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Precision (CLSI EP5-A3):
- Sample Size: Not specified, but involved seven (7) human serum samples and two (2) QC samples.
- Study Design: 21 days x 2 runs per day x 2 replicates per sample.
- Key Results: Repeatability and intermediate precision were evaluated. Total error was calculated using the one-sided Westgard-Model (TE = 1.65*CV + %bias). Data was found acceptable with %CV and % Total Error reported for various PCT concentrations.
-
Sample Matrix Comparison:
- Sample Size: A minimum of 40 serum/plasma pairs per sample material.
- Study Type: Comparison of PCT values in serum and Li-Heparin, K2-EDTA, K3-EDTA plasma tubes.
- Key Results: Data evaluated using Passing/Bablok regression analysis to assess the effect of anticoagulants.
-
Endogenous Interferences:
- Study Type: Evaluation of the effect of five endogenous interfering substances (Hemoglobin, Biotin, Intralipid, Bilirubin, and Rheumatoid Factor) on PCT quantitation.
- Key Results: Substances were found not to affect test performance at clinically relevant concentrations. Recovery was within ± 15 % of the initial value for PCT concentrations > 0.1 ng/mL and within 0.015 ng/mL for concentrations below 0.1 ng/mL.
-
Exogenous Interferences (Drugs):
- Study Type: Evaluation of the effect of 34 pharmaceutical compounds on PCT quantitation.
- Key Results: Substances were found not to affect test performance at the tested concentrations. Recovery was within ± 10 % of the reference value.
-
Analytical Specificity/Cross-reactivity:
- Study Type: Determination of specificity using native human serum samples spiked with potential cross-reactant compounds (human katacalcin, human calcitonin, human alpha-CGRP, human beta-CGRP, Calcitonin Salmon, Calcitonin Eel).
- Key Results: Recovery within ± 15 % of initial value at PCT concentrations of ~0.5 ng/mL and ~2 ng/mL was verified for the tested cross-reactant concentrations.
-
Reagent On-Board Stability:
- Study Type: Assessment of the Elecsys BRAHMS PCT reagent kit stability when kept on board the analyzer.
- Key Results: Elecsys BRAHMS PCT reagent kits can be kept on board of the instruments for up to 4 weeks (28 days). A new calibration of the kit kept on board is recommended every 7 days.
-
Calibration Stability:
- Study Type: Evaluation of calibration stability over time.
- Key Results: Data supports the package-insert claim of 8 weeks lot calibration stability when using the same reagent kit lot.
-
LoQ (CLSI EP17-A2):
- Sample Size: Seven native human serum (HS) samples.
- Study Type: Determination of Limit of Quantitation.
- Key Results: The LoQ was determined to be 0.025 ng/mL. The LoQ claim for the Elecsys BRAHMS PCT assay is 0.06 ng/mL. Total error values were calculated for different expected values.
-
Clinical Performance Evaluation - Method Comparison to Predicate:
- Sample Size: 496 native serum human clinical samples.
- Study Type: Concordance analysis and regression analysis (Passing-Bablok and Weighted Deming) of Elecsys BRAHMS PCT assay compared to the predicate device.
- Key Results: More than 96% total agreement between the Elecsys BRAHMS PCT and the predicate device at medical decision points 0.1, 0.25, 0.5 and 2.0 ng/mL. Regression slopes were within +/- 10% of identity in Passing-Bablok and Weighted Deming Analysis, demonstrating equivalence. Pearson's r Correlation Coefficient was 1.000 for both regression analyses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- PCT Agreement between Elecsys BRAHMS PCT and Predicate at 0.1 ng/mL:
- Total Agreement: 98.4%
- Cohen's Kappa: 0.960
- PCT Agreement between Elecsys BRAHMS PCT and Predicate at 0.25 ng/mL:
- Total Agreement: 98.6%
- Cohen's Kappa: 0.971
- PCT Agreement between Elecsys BRAHMS PCT and Predicate at 0.5 ng/mL:
- Total Agreement: 99.2%
- Cohen's Kappa: 0.984
- PCT Agreement between Elecsys BRAHMS PCT and Predicate at 2.0 ng/mL:
- Total Agreement: 99.0%
- Cohen's Kappa: 0.975
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".
March 9, 2020
Roche Diagnostics Wes Gerbig Regulatory Affairs Principal 9115 Hague Road Indianapolis, Indiana 46250
Re: K192815
Trade/Device Name: Elecsys BRAHMS PCT 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: PRI, PMT, NTM Dated: September 27, 2019 Received: October 1, 2019
Dear Wes Gerbig:
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.
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
1
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 (OS) 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. Chief Bacterial Multiplex and Medical Counter Measures Branch Division of Microbiology OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192815
Device Name Elecsys BRAHMS PCT
Indications for Use (Describe) Elecsys BRAHMS PCT
Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Used in conjunction with other laboratory findings and clinical assessments, Elecsys 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 determine the change in PCT level over time as an 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,
· to aid in decision making on antibiotic therapy, for inpatients in the emergency department 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),
· to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.
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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Elecsys BRAHMS PCT
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.
In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).
The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the Elecsys BRAHMS PCT Test System.
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| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0457 | |
| Contact | Wes Gerbig |
| Phone: (317) 521-3743 | |
| FAX: (317) 521-2324 | |
| Email: wes.gerbig@roche.com | |
| Secondary Contact Name | |
| Tammy Dean | |
| Phone: 317-521-3978 | |
| FAX: (317) 521-2324 | |
| Email: tammy.dean@roche.com | |
| Date Prepared | September 30, 2019 |
| Proprietary Name | Elecsys BRAHMS PCT |
| Common Name | Procalcitonin |
| Classification Name | Device to detect and measure non-microbial analyte(s) in human clinical |
| specimens to aid in assessment of patients with suspected sepsis | |
| Product Codes, | |
| Regulation Numbers | PRI, PMT, NTM, 866.3215 |
| Predicate Devices | Elecsys BRAHMS PCT cleared under K173927. |
| Establishment Registration | For the Elecsys BRAHMS PCT Test System the establishment registration |
| number for Roche Diagnostics GmbH in Mannheim, Germany is 9610126, and | |
| for Penzberg, Germany, 9610529. The establishment registration number for | |
| Roche Diagnostics in the United States is 1823260. |
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1. Device Description
The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. An optional Procalcitonin CalCheck product is also available.
1.1. Reagents
The reagent working solutions include:
Rackpack (kit placed on analyzer)
- M: Streptavidin-coated microparticles,
- . R1: Anti-PCT-Ab~biotin
- . R2: Anti-PCT-Ab~Ru(bpy)32+
The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay. Briefly, Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates.
6
2. INDICATIONS FOR USE
Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 -EDTA, K3-EDTA and Li-Heparin).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS 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 determine the change in PCT level over time as an aid in assessing the cumulative 28day 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,
- to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department 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),
- . to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.
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3. Technological Characteristics
| Table 1: | Assay Comparison | |
|---|---|---|
| ---------- | -- | ------------------ |
| Feature | Predicate Device: Elecsys BRAHMS PCT
(K173927) | Candidate Device: Elecsys BRAHMS
PCT with biotin update |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for Use | Immunoassay for the in vitro quantitative
determination of PCT (procalcitonin) in human
serum and plasma (K2 –EDTA, K3-EDTA and
Li-Heparin).
The electrochemiluminescence immunoassay
"ECLIA" is intended for use on Elecsys and
cobas e immunoassay analyzers.
Used in conjunction with other laboratory
findings and clinical assessments, Elecsys
BRAHMS 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 determine the change in PCT level
over time as an 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,
● to aid in decision making on antibiotic
therapy, for inpatients or patients in the
emergency department 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),
● to aid in decision making on antibiotic
discontinuation for patients with
suspected or confirmed sepsis. | Same with the exception of
intended analyzers, Elecsys
BRAHMS PCT with biotin update
is only intended for use on cobas e
innunoassay analyzers. |
| Assay Protocol | The Elecsys BRAHMS PCT assay is a two-step
sandwich immunoassay with streptavidin
microparticles and an
electrochemiluminescence detection system.
The test system reagents contain a biotinylated
monoclonal PCT-specific antibody and a
ruthenium labeled monoclonal PCT-specific
antibody. | Same |
| Detection Protocol | Electrochemiluminescent immunoassay | Same |
| Applications | 18-minute application | Same |
| Instrument Platform | cobas e 411 analyzer | cobas e 601 analyzer |
| Sample Volume | 30 μL | Same |
| Sample Type | Human serum and plasma (Li-Heparin, K2/K3
EDTA) | Same |
| Reagents | M: Streptavidin-coated microparticles:
Steptavidin-coated microparticles; preservative
R1: Anti-PCT-Abbiotin:Ru(bpy)32+ a monoclonal
Biotinylated monoclonal anti-PCT antibody
(mouse), phosphate buffer, preservative
R2: Anti-PCT – Ab
anti-PCT antibody (mouse) labeled with
ruthenium complex, phosphate buffer,
preservative | M: Streptavidin-coated microparticles:
Steptavidin-coated microparticles;
preservative
R1: Anti-PCT-Abbiotin:Ru(bpy)32+ a
Biotinylated monoclonal anti-PCT
antibody (mouse), phosphate buffer,
preservative
R2: Anti-PCT – Ab
monoclonal anti-PCT antibody (mouse)
labeled with ruthenium complex,
Biotin Scavenger Anti-body,
phosphate buffer, preservative
Roche is taking a one-step approach by
adding an antibody to bind free biotin
in the sample. For the neutralization of
free biotin in serum and plasma, Roche
developed an antibody which binds to
free biotin. The antibodies are specific
for free biotin and do not bind to, or
interact with, the biotin-linker
conjugates. |
| Calibrator | PCT Cal1 and PCT Cal2 | Same |
| Calibration Interval | Calibration must be performed once per reagent
lot using PCT Cal1, PCT Cal2 and fresh
reagent (i.e. not more than 24 hours since the
reagent kit was registered on the analyzer).
Renewed calibration is recommended as
follows:
• after 8 weeks when using the same
reagent lot
• after 7 days (when using the same
reagent kit on the analyzer)
• as required: e.g. quality control findings
outside the specified limits | Same |
| Controls | PC PCT1 and PC PCT2 | Same |
| Traceability/ Standardization | This method has been standardized against the
BRAHMS PCT LIA assay. | Same |
| Reagent Stability | Store at 2-8 °C. Do not freeze. Store the
Elecsys reagent kit upright in order to ensure
complete availability of the microparticles
during automatic mixing prior to use.
Stability:
● unopened at 2-8 ℃: up to the stated
expiration date
● after opening at 2-8 ℃: 12 weeks
● on the analyzers: 4 weeks | Same |
| Measuring Range | 0.02 - 100 ng/mL | Same |
| LoB | 0.015 ng/mL | Same |
| LoD | 0.02 ng/mL | Same |
| LoQ | 0.06 ng/mL | Same |
| Hook Effect | No hook effect up to 1000 ng/mL | Same |
| Biotin Limitations | Biotin interference can produce either falsely
high or low results. Though the risk of
misclassifying a test result due to biotin
interference is lower than the risks from
average assay imprecision, biological
variability, or other known interference,
patient biotin intake and the resulting % bias
should be taken into account when interpreting
PCT assay values. (See Interference study
below).
Do not test samples from patients who have
indicated or whose clinical status or history
would indicate they are currently taking high
doses of biotin (> 10 mg per day). If biotin
interference is suspected, follow your
established internal procedures to investigate
the interference per CLIA and GLP
recommendations.
Serial draws are indicated for procalcitonin
measurements. Biotin will metabolize and
clear, serum levels will reduce over time. | Specimens with biotin concentrations
up to 1200 ng/mL did not demonstrate
bias in measured PCT values.
Specimens with biotin concentrations >
1200 ng/mL and ≤ 2600 ng/mL
demonstrated ≤ 10 % negative bias in
measured PCT levels. Pharmacokinetic
studies have shown that serum
concentrations of biotin can reach up to
355 ng/mL within the first hour after
biotin ingestion for subjects consuming
supplements of 20 mg biotin per day
and up to 1160 ng/mL for subjects after
a single dose of 300 mg biotin. |
| Method Comparison | 474 samples were run on the cobas e 601 and the predicate device (Elecsys BRAHMS
PCT K173927)
Passing Bablok
Slope: 0.990 (95% CI: 0.984; 0.994)
Intercept: -0.003 ng/mL (95% CI: -0.004; -0.001)
Pearson's r Coefficient: 1.000 | |
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4. PERFORMANCE EVALUATION
The following data was requested by the FDA in Q171237/S0001 to support the updated
Indications for Use statement and is listed below:
- . Precision according to CLSI EP5-A3
- Serum/Plasma Comparison
- Interferences – Endogenous
- Interferences Exogenous (Drugs) ●
- Analytical Specificity/Cross-reactivity ●
- . Calibration Lot and On-board Stability
- Analytical Sensitivity: LoO according to CLSI EP17-A2 ●
- Clinical Performance Evaluation Method Comparison to Predicate .
The remaining data required to support the updated Indications for Use was supplied in the previous submissions K160729 and K173927:
- . Analytical Sensitivity: LoB and LoD
- . Linearity according to CLSI EP6-A
- High Dose Hook Effect
- Human Anti-Mouse Antibodies (HAMA)
- . Sample Stability
4.1. Precision
The repeatability and intermediate precision of the Elecsys BRAHMS PCT assay was conducted using the cobas e 601 analyzer. Studies were performed in accordance with CLSI guideline EP5-
11
A3, "Evaluation of Precision Performance of Quantitative Measurement Methods". One reagent lot was evaluated. The precision study was conducted using the study design of 21 days x 2 runs per day x 2 replicates per sample. One (1) instrument was used for the study and calibration was performed according to the Instructions for Use. Aliquots of seven (7) human serum samples and two (2) QC samples (PC PCT 1 and PC PCT 2) distributed over the measuring range were assayed in duplicate and randomized order on the cobas e 601 analyzer using one lot of reagent. Data is acceptable and is summarized below. An analysis was also performed to calculate % Total Error across the measuring range. The total error was calculated using the one sided Westgard-Model as:
TE = 1.65* CV + %bias
The %CV used corresponds to the intermediate precision.
| Sample | Mean
(ng/mL) | Repeatability (CV%) | | Intermediate Precision
(CV%) | | % Total Error |
|----------|-----------------|---------------------|------|---------------------------------|------|---------------|
| | | Within Run | | Within Lab | | |
| | | SD (ng/mL) | CV% | SD (ng/mL) | CV% | |
| Control1 | 0.478 | 0.012 | 2.5 | 0.020 | 4.3 | 10.6 |
| Control2 | 10.0 | 0.119 | 1.2 | 0.306 | 3.1 | 7.44 |
| Sample1 | 0.045 | 0.006 | 13.2 | 0.007 | 16.1 | 39.9 |
| Sample2 | 0.112 | 0.007 | 6.3 | 0.010 | 8.6 | 21.3 |
| Sample3 | 0.249 | 0.008 | 3.0 | 0.011 | 4.3 | 10.4 |
| Sample4 | 0.495 | 0.013 | 2.7 | 0.021 | 4.2 | 10.3 |
| Sample5 | 1.71 | 0.031 | 1.8 | 0.058 | 3.4 | 8.09 |
| Sample6 | 31.4 | 0.326 | 1.0 | 0.985 | 3.1 | 7.38 |
| Sample7 | 93.0 | 1.52 | 1.6 | 3.40 | 3.7 | 8.71 |
Table 2: Summary of Precision Results – Elecsys BRAHMS PCT Repeatability and Intermediate Precision
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Sample Matrix Comparison 4.2.
The effect on quantitation of analyte in the presence of anticoagulants with the Elecsys BRAHMS PCT immunoassay was determined by comparing values obtained from samples (native human serum samples, single donors as well as pools) drawn into serum and Li-Heparin, K2-EDTA, K3-EDTA plasma tubes. A minimum of 40 serum/plasma pairs per sample material were tested in singleton with one reagent lot on one cobas e 601 analyzer. Data were evaluated using a regression analysis according to Passing/Bablok.
Endogenous Interferences 4.3.
The effect on quantitation of PCT in the presence of five endogenous interfering substances (Hemoglobin, Biotin, Intralipid, Bilirubin, and Rheumatoid Factor) was tested using one cobas e 601 analyzer. Spiked serum pools were used for testing. The substances were found not to affect test performance at clinically relevant concentrations. Recovery was within ± 15 % of the initial value for PCT concentrations > 0.1 ng/mL and within 0.015 ng/mL for concentrations below 0.1 ng/mL
| Potential Interferent | Claim |
|---|---|
| Intralipid | 1500 mg/dL |
| Biotin | 1200 ng/mL |
| Bilirubin | 25 mg/dL |
| Hemoglobin | 900 mg/dL |
| Rheumatic Factor | 1500 IU/mL |
Table 3: Potentially Interfering Endogenous Substances and Test Concentrations
4.4. Exogenous Interferences - Drugs
The effect on quantitation of analyte in the presence of drugs was determined by comparing values obtained from samples spiked with 34 pharmaceutical compounds into two human serum
13
samples and tested on the cobas e 601 analyzer. The substances were found not to affect test
performance at the tested concentration. Recovery was within ± 10 % of the reference value.
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Table 4: Potentially Interfering Drugs and Test Concentrations
| Potential Interferent | Drug Level Tested (mg/L) |
|---|---|
| Acetylcysteine | 150 |
| Ampicillin | 75 |
| Ascorbic acid | 52.5 |
| Cyclosporine | 1.8 |
| Cefoxitin | 750 |
| Heparin | 3300 U/L |
| Levodopa | 7.5 |
| Methyldopa | 22.5 |
| Metronidazole | 123 |
| Phenylbutazone | 321 |
| Doxycycline | 18 |
| Acetylsalicylic acid | 30 |
| Rifampicin | 48 |
| Acetaminophen | 156 |
| Ibuprofen | 219 |
| Theophylline | 60 |
| Imipenem | 1180 |
| Cefotaxime | 900 |
| Vancomycin | 3500 |
| Dopamine | 130 |
| Noradrenaline | 2 |
| Dobutamine | 11.2 |
| Furosemide | 20 |
| Cromolyn | 24 |
| Alcohol | 4000 |
| Azithromycin | 11.5 |
| Cetirizine HCl | 3.6 |
| Dextromethorphan | 1.4 |
| Levofloxacin | 17.5 |
| Loratadine | 0.3 |
| Nicotine | 1 |
| Oxymetazoline HCl | 0.09 |
| Phenylephrine | 0.18 |
| Tiotropium | 0.0216 |
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Analytical Specificity/Cross-reactivity 4.5.
The specificity of the Elecsys® BRAHMS PCT was determined using native human serum samples spiked with potential cross-reactant compounds.
The samples were tested on a cobas e 601 Immunoassay Analyzer. Recovery within ± 15 % of initial value at PCT concentrations of ~0.5 ng/mL and ~2 ng/mL were verified for the following cross-reactant concentrations:
- 30 ng/mL human katacalcin
- 10 ng/mL human calcitonin
- 10000 ng/mL human alpha-CGRP
- 10000 ng/mL human beta-CGRP
- . 30000 ng/mL Calcitonin Salmon
- . 30000 ng/mL Calcitonin Eel
4.6. Reagent On-Board Stability
A fresh Elecsys BRAHMS PCT test kit was placed on the cobas e 601 analyzer and calibrated. Reference values for the samples tested were determined (day 0). After 8, 15, 22 and 29 days (1, 2, 3 and 4 weeks) the same samples were measured with the same reagent kit kept under onboard condition. Re-calibration was performed at every measuring time point.
Samples tested include eight (8) human serum (HS) sample pools. Each sample was tested in two-fold determination. Samples were targeted with values near medical decision levels of 0.1 ng/mL, 0.25 ng/mL, 0.5 ng/mL and 2.0 ng/mL as one sample range, along with sample ranges at low, medium and high PCT concentration ranges relative to the measuring range. Mean recovery values for each sample range were calculated. Elecsys BRAHMS PCT reagent kits can be kept on board of the instruments for up to 4 weeks (28 days). A new calibration of the kit kept
16
on board is recommended every 7 days.
4.7. Calibration Stability
The Elecsys BRAHMS PCT assay was calibrated with a fresh reagent kit on Day 0 using one cobas e 601 analyzer. After 3, 6, and 9 weeks a new reagent kit of the same lot was used with recovery of samples being determined using the calibration curve established on Day 0 for that reagent kit lot. Forteen (14) human serum samples were tested in duplicate. Recovery compared to the reference value was calculated as absolute deviation in ng/mL or relative deviation in %. Samples were targeted with values near medical decision levels of 0.1 ng/mL, 0.25 ng/mL, 0.5 ng/mL and 2.0 ng/mL along with samples spread across the measuring range. Mean recovery values for each sample range were calculated. The resulting data support the package-insert claim of 8 weeks lot calibration stability when using the same reagent kit lot.
4.8. LoQ according to CLSI EP17-A2
The Limit of Quantitation (LoO) of the Elecsys BRAHMS PCT assay was determined according to CLSI EP17-A2. The LoQ represents the lowest amount of analyte that can be quantitatively determined with stated accuracy, precision, and experimental conditions. The LoQ was calculated based on intermediate precision according to CLSI EP17-A2. The LoQ was determined as the lowest concentration of analyte that can be quantified with an intermediate precision of no more than 20%.
A five-day LoQ experiment was carried out with one reagent lot on one cobas e 601 analyzer. Samples tested included seven native human serum (HS) samples and were measured in five-fold determination for each run. A total of 150 measuring points were collected.
The mean values and the intermediate precision (coefficient of variation and standard deviation) for each LoQ sample were calculated. To determine the LoQ, samples were sorted according to the concentration of their measured mean value. The LoO is defined as the mean value of the
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sample that is first to fulfill the specification for intermediate precision, and for which there is no lower-concentration sample that exceeds the specification. The LoQ data are represented in the table below.
| Sample
Type | Day | | | | | Mean
(ng/mL) | SD
(ng/mL) | CV (%) |
|------------------|-------|-------|-------|-------|-------|-----------------|---------------|--------|
| | 1 | 2 | 3 | 4 | 5 | | | |
| HS 1 | 0.032 | 0.029 | 0.026 | 0.021 | 0.021 | 0.025 | 0.004 | 18.0 |
| | 0.030 | 0.021 | 0.031 | 0.028 | 0.028 | | | |
| | 0.022 | 0.023 | 0.022 | 0.021 | 0.020 | | | |
| | 0.033 | 0.020 | 0.032 | 0.023 | 0.024 | | | |
| | 0.029 | 0.024 | 0.025 | 0.022 | 0.018 | | | |
| HS 2 | 0.042 | 0.041 | 0.043 | 0.041 | 0.045 | 0.043 | 0.003 | 7.7 |
| | 0.046 | 0.044 | 0.037 | 0.041 | 0.041 | | | |
| | 0.050 | 0.039 | 0.043 | 0.043 | 0.044 | | | |
| | 0.038 | 0.047 | 0.037 | 0.040 | 0.045 | | | |
| | 0.048 | 0.045 | 0.044 | 0.043 | 0.045 | | | |
| HS 3 | 0.056 | 0.057 | 0.052 | 0.052 | 0.057 | 0.049 | 0.004 | 9.0 |
| | 0.050 | 0.046 | 0.048 | 0.040 | 0.046 | | | |
| | 0.051 | 0.048 | 0.048 | 0.044 | 0.052 | | | |
| | 0.047 | 0.043 | 0.045 | 0.045 | 0.049 | | | |
| | 0.053 | 0.054 | 0.050 | 0.046 | 0.050 | | | |
| HS 4 | 0.066 | 0.063 | 0.067 | 0.059 | 0.062 | 0.066 | 0.004 | 5.8 |
| | 0.068 | 0.058 | 0.070 | 0.064 | 0.064 | | | |
| | 0.067 | 0.068 | 0.064 | 0.073 | 0.062 | | | |
| | 0.069 | 0.065 | 0.071 | 0.073 | 0.067 | | | |
| | 0.068 | 0.064 | 0.065 | 0.062 | 0.061 | | | |
| HS 5 | 0.069 | 0.062 | 0.068 | 0.067 | 0.068 | 0.066 | 0.004 | 6.8 |
| | 0.068 | 0.067 | 0.058 | 0.058 | 0.056 | | | |
| | 0.072 | 0.063 | 0.073 | 0.066 | 0.068 | | | |
| | 0.072 | 0.065 | 0.063 | 0.064 | 0.062 | | | |
| | 0.072 | 0.065 | 0.069 | 0.064 | 0.067 | | | |
| HS 6 | 0.088 | 0.090 | 0.088 | 0.083 | 0.089 | 0.089 | 0.004 | 4.4 |
| | 0.091 | 0.092 | 0.089 | 0.093 | 0.089 | | | |
| | 0.092 | 0.091 | 0.090 | 0.084 | 0.084 | | | |
| | 0.095 | 0.085 | 0.094 | 0.091 | 0.097 | | | |
| | 0.090 | 0.095 | 0.086 | 0.083 | 0.085 | | | |
| LoQ: 0.025 ng/mL | | | | | | | | |
Table 5. LoQ Data – cobas e 601 analyzer
HS: human serum
The LoQ was determined to be 0.025 ng/mL. The LoQ claim for the Elecsys BRAHMS PCT assay is 0.06 ng/mL.
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Based on LoQ testing the following total error values were calculated.
| Expected value (ng/ml) | %CV | Elecsys BRAHMS PCT | %Bias | %TE |
|---|---|---|---|---|
| 2.00 | 0.19 | 0.12 | 0.43 | |
| 0.50 | 0.77 | 0.54 | 1.81 | |
| 0.30 | 1.30 | 0.94 | 3.08 | |
| 0.25 | 1.56 | 1.15 | 3.72 | |
| 0.15 | 2.64 | 2.00 | 6.34 | |
| 0.10 | 3.99 | 3.10 | 9.69 | |
| 0.05 | 8.12 | 6.56 | 19.97 |
Table 6: Total Error
Clinical Performance Evaluation - Method Comparison to Predicate 4.9.
A method comparison of the Elecsys BRAHMS PCT assay and the predicate was performed using 496 native serum human clinical samples. A concordance analysis was performed with the predicate device. Only samples in which the result from the candidate and the predicate device were within the measuring range were included in the concordance analysis. The clinical concordance analysis of the Elecsys BRAHMS PCT clinical performance study shows more than 96% total agreement between the Elecsys BRAHMS PCT and the predicate device at the medical decision points 0.1, 0.25, 0.5 and 2.0 ng/mL. The regression slopes are within +/- 10% of identity in Passing-Bablok and Weighted Deming Analysis. This demonstrates equivalence to the predicate device to include all currently cleared claims of the predicate device in the labeling of the candidate device.
Further clinical performance study data can be found referenced in K173927 and K160729.
| Table 7: PCT Agreement between Elecsys BRAHMS PCT and Predicate at 0.1 ng/mL | ||
|---|---|---|
| -- | -- | ------------------------------------------------------------------------------ |
| Elecsys BRAHMS PCT on
| cobas e 601 | Predicate | Total | |
|---|---|---|---|
| > 0.1 ng/mL | ≤ 0.1 ng/mL | ||
| > 0.1 ng/mL | 354 | 1 | 355 |
| ≤ 0.1 ng/mL | 7 | 134 | 141 |
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| ﺍﯾﮏ ﮐﯿﺎ ﮨﮯ ﮐﮧ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾ | C |
|---|
Table 8: PCT Agreement between Elecsys BRAHMS PCT and Predicate at 0.25 ng/mL
| Elecsys BRAHMS PCT on
| cobas e 601 | Predicate | Total | |
|---|---|---|---|
| > 0.25 ng/mL | ≤ 0.25 ng/mL | ||
| > 0.25 ng/mL | 278 | 1 | 279 |
| ≤ 0.25 ng/mL | 6 | 211 | 217 |
| Total | 284 | 212 | 496 |
PCT Agreement between Elecsys BRAHMS PCT and Predicate at 0.5 ng/mL Table 9:
| Elecsys BRAHMS PCT on
| cobas e 601 | Predicate | Total | |
|---|---|---|---|
| > 0.5 ng/mL | ≤ 0.5 ng/mL | ||
| > 0.5 ng/mL | 220 | 0 | 220 |
| ≤ 0.5 ng/mL | 4 | 272 | 276 |
| Total | 224 | 272 | 496 |
Table 10: PCT Agreement between Elecsys BRAHMS PCT and Predicate at 2.0 ng/mL
| Elecsys BRAHMS PCT on
| cobas e 601 | Predicate | Total | |
|---|---|---|---|
| > 2.0 ng/mL | ≤ 2.0 ng/mL | ||
| > 2.0 ng/mL | 141 | 2 | 143 |
| ≤ 2.0 ng/mL | 3 | 350 | 353 |
| Total | 144 | 352 | 496 |
Table 11: Comparison Elecsys BRAHMS PCT vs Predicate
N = 496 (135 ≤ 0.1 ng/mL, 212 ≤ 0.25 ng/mL; 272 ≤ 0.5 ng/mL; 352 ≤ 2.0 ng/mL)
| Cutoff (> vs. ≤) | Positive Agreement
(95% CI) | Negative Agreement
(95% CI) | Total Agreement | Cohen's Kappa |
|------------------|--------------------------------|--------------------------------|-----------------|---------------|
| 0.10 ng/mL | 98.1%
(96.1 - 99.1) | 99.3%
(95.9 - 99.9) | 98.4% | 0.960 |
| 0.25 ng/mL | 97.9%
(95.5 - 99.0) | 99.5%
(97.4 - 99.9) | 98.6% | 0.971 |
| 0.50 ng/mL | 98.2%
(95.5 - 99.3) | 100.0%
(98.6 -100.0) | 99.2% | 0.984 |
| 2.00 ng/mL | 97.9%
(94.1 - 99.3) | 99.4%
(98.0 - 99.8) | 99.0% | 0.975 |
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Table 12: Weighted Deming and Passing Bablok Regression Analysis
| Parameter | Passing Bablok Regression | Weighted Deming (λ=1) Regression
Analysis |
|-------------------------------------|---------------------------|----------------------------------------------|
| n | 474 | 474 |
| Slope | 0.990 | 0.969 |
| 95% CI | [0.984; 0.994] | [0.963; 0.975] |
| Intercept | -0.003 | 0.004 |
| 95% CI | [-0.004; -0.001] | [0.002; 0.005] |
| Pearson Correlation Coefficient (R) | 1.000 | 1.000 |
| Sample Range | [0.02; 85.69] | [0.02; 85.69] |
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Figure 1: Weighted Deming Regression plots of Elecsys BRAHMS PCT versus Predicate
Image /page/21/Figure/3 description: This image is a scatter plot that compares two different methods of measuring a certain quantity. The x-axis represents the Elecsys Brahms PCT, and the y-axis represents the Biotin Update Elecsys Brahms PCT. The plot includes a regression line, represented by the equation 0 + 0.97 * X, and an identity line. The Pearson's r correlation coefficient is 1, and the weighted Deming regression fit has n=474.
Weighted Deming Regression Fit, Instruments Pooled
Elecsys Brahms PCT
22
Figure 2: Passing Bablok Regression plots of Elecsys BRAHMS PCT versus Predicate
Image /page/22/Figure/3 description: This image is a scatter plot that shows the correlation between two different methods of measuring Biotin. The x-axis represents the Elecsys Brahms PCT, and the y-axis represents the Biotin Update Elecsys Brahms PCT. The plot includes a Passing Bablok Regression Fit line, represented by the equation 0 + 0.99 * X, and an identity line. The Pearson's r correlation coefficient is 1, indicating a strong positive correlation between the two methods, and the sample size is 474.
Passing Bablok Regression Fit, Instruments Pooled
Elecsys Brahms PCT
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5. ADDITIONAL INFORMATION
The calibration materials PCT Cal1 and PCT Cal2 as well as the control material PreciControl PCT1 and PreciControl PCT2 are in the Elecsys BRAHMS PCT kit and are not changed as a result of the new claims. The Elecsys BRAHMS PCT CalCheck 5 is also not changed as a result of the change. See K160729 for additional information.
6. CONCLUSIONS
The information provided in this 510(k) Premarket Notification will support a determination of substantial equivalence for the Elecsys BRAHMS PCT test system. The data supports a safe, effective device which performs as well as or better than the predicate device.