Elecsys BRAHMS PCT

K173927 · Roche Diagnostics · PRI · Jul 6, 2018 · Microbiology

Device Facts

• Record ID: K173927
• Device Name: Elecsys BRAHMS PCT
• Applicant: Roche Diagnostics
• Product Code: PRI · Microbiology
• Decision Date: Jul 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3215
• Device Class: Class 2

Intended 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 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.

Device Story

Elecsys BRAHMS PCT is a two-step sandwich immunoassay for quantitative procalcitonin (PCT) measurement in human serum/plasma. Input: patient sample; process: PCT reacts with biotinylated anti-PCT antibody and ruthenium-labeled anti-PCT antibody, forming a sandwich complex captured on streptavidin-coated magnetic microparticles; detection: voltage applied to electrode induces chemiluminescence measured by photomultiplier tube. Used on Elecsys/cobas e analyzers in clinical laboratories. Output: PCT concentration (ng/mL) determined via calibration curve. Clinicians use results alongside clinical assessments to guide antibiotic therapy and assess sepsis/mortality risk. Benefits: aids in timely clinical decision-making for critically ill patients.

Clinical Evidence

Retrospective multicenter study (n=2617) of adult patients with severe sepsis or septic shock. Compared Elecsys BRAHMS PCT to predicate (KRYPTOR). Results showed >97% total agreement at medical decision points (0.1, 0.25, 0.5, 2.0 ng/mL). Passing-Bablok slope 0.959 (95% CI: 0.947-0.972); intercept -0.023. Pearson correlation 0.989. Precision studies (CLSI EP5-A3) showed intermediate precision CVs ranging from 2.2% to 24.3% across the measuring range.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection. Reagents: streptavidin-coated magnetic microparticles, biotinylated monoclonal anti-PCT antibody, ruthenium-labeled monoclonal anti-PCT antibody. Measuring range: 0.02-100 ng/mL. Sample volume: 30 µL. Platform: Elecsys/cobas e immunoassay analyzers. Standardized against BRAHMS PCT LIA assay.

Indications for Use

Indicated for adult patients (>18 years) with suspected or confirmed sepsis, severe sepsis, septic shock, or lower respiratory tract infections (CAP, acute bronchitis, AECOPD). Used to aid in ICU risk assessment, 28-day mortality risk assessment, and antibiotic therapy decision-making. Contraindicated for use as a stand-alone diagnostic; results must be interpreted with clinical status and other laboratory findings.

Regulatory Classification

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.

Special Controls

A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis must comply with the following special controls:

*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 820.10(c) design and development, 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.

Predicate Devices

• B.R.A.H.M.S. PCT sensitive KRYPTOR® (K171338)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

July 6, 2018

Roche Diagnostics Wes Gerbig Regulatory Affairs Principal 9115 Hague Road Indianapolis, Indiana 46250

Re: K173927

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: PMT Dated: December 22, 2017 Received: December 26, 2017

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. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

{1}------------------------------------------------

803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# 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) K173927

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) | |
|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CER 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CER 801 Subpart C) </span> </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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.

{4}------------------------------------------------

| Submitter Name | Roche Diagnostics |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 9115 Hague Road<br>P.O. Box 50416<br>Indianapolis, IN 46250-0457 |
| Contact | Wes Gerbig<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| | Secondary Contact Name<br>Michael Leuther<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Date Prepared | December 22, 2017 |
| Proprietary Name | Elecsys BRAHMS PCT |
| Common Name | Procalcitonin |
| Classification Name | Device to detect and measure non-microbial analyte(s) in human clinical<br>specimens to aid in assessment of patients with suspected sepsis |
| Product Codes,<br>Regulation Numbers | PRI, PMT, NTM, 866.3215 |
| Predicate Devices | B.R.A.H.M.S. PCT sensitive KRYPTOR® cleared under K171338. |
| Establishment Registration | For the Elecsys BRAHMS PCT Test System the establishment registration<br>number for Roche Diagnostics GmbH in Mannheim, Germany is 9610126, and<br>for Penzberg, Germany, 9610529. The establishment registration number for<br>Roche Diagnostics in the United States is 1823260. |

{5}------------------------------------------------

#### 1. DEVICE DESCRIPTION

The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles and an electrochemiluminescence detection system. 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) == ●

#### 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 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,

{6}------------------------------------------------

- 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.

{7}------------------------------------------------

#### TECHNOLOGICAL CHARACTERISTICS 3.

### Table 1: Assay Comparison

| Feature | Candidate Device: Elecsys BRAHMS<br>PCT | Predicate Device: B.R.A.H.M.S.<br>PCT sensitive KRYPTOR®<br>(K171338). |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/<br>Indications for Use | Immunoassay for the in vitro quantitative<br>determination of PCT (procalcitonin) in<br>human serum and plasma (K2 –EDTA,<br>K3-EDTA and Li-Heparin).<br>The electrochemiluminescence<br>immunoassay "ECLIA" is intended for use<br>on Elecsys and cobas e immunoassay<br>analyzers.<br>Used in conjunction with other laboratory<br>findings and clinical assessments, Elecsys<br>B·R·A·H·M·S PCT is intended for use as<br>follows:<br>• to aid in the risk assessment of<br>critically ill patients on their first day<br>of ICU admission for progression to<br>severe sepsis and septic shock,<br>• to determine the change in PCT<br>level over time as an aid in<br>assessing the cumulative 28-day<br>risk of all-cause mortality for<br>patients diagnosed with severe<br>sepsis or septic shock in the ICU or<br>when obtained in the emergency<br>department or other medical wards<br>prior to ICU admission,<br>• to aid in decision making on<br>antibiotic therapy, for inpatients or<br>patients in the emergency<br>department with suspected or<br>confirmed lower respiratory tract<br>infections (LRTI) – defined as<br>community-acquired pneumonia<br>(CAP), acute bronchitis, and acute<br>exacerbation of chronic obstructive<br>pulmonary disease (AECOPD),<br>• to aid in decision making on<br>antibiotic discontinuation for<br>patients with suspected or<br>confirmed sepsis. | The B·R·A·H·M·S PCT sensitive<br>KRYPTOR® is an<br>immunofluorescent assay using<br>Time-Resolved Amplified Cryptate<br>Emission (TRACE®) technology to<br>determine the concentration of PCT<br>(procalcitonin) in human serum and<br>EDTA or<br>heparin plasma.<br>The B·R·A·H·M·S PCT sensitive<br>KRYPTOR® is intended to be<br>performed on the B·R·A·H·M·S<br>KRYPTOR® analyzer<br>family.<br>Used in conjunction with other<br>laboratory findings and clinical<br>assessments, B·R·A·H·M·S PCT<br>sensitive KRYPTOR®<br>is intended for use as follows:<br>• to aid in the risk assessment<br>of critically ill patients on<br>their first day of ICU<br>admission for progression to<br>severe sepsis and septic<br>shock,<br>• to determine the change in<br>PCT level over time as an<br>aid in assessing the<br>cumulative 28-day risk of all-<br>cause mortality for patients<br>diagnosed with severe<br>sepsis or septic shock in the<br>ICU or when obtained in the<br>emergency department or<br>other medical wards prior to<br>ICU admission, |
| Intended Use/ | | • to aid in decision making on<br>antibiotic therapy, for |
| Feature | Candidate Device: Elecsys BRAHMS<br>PCT | Predicate Device: B.R.A.H.M.S.<br>PCT sensitive KRYPTOR®<br>(K171338). |
| Indications for Use Continued | | inpatients or patients in the<br>emergency department with<br>suspected or confirmed<br>lower respiratory tract<br>infections (LRTI) – defined<br>as community-acquired<br>pneumonia (CAP), acute<br>bronchitis, and acute<br>exacerbation of chronic<br>obstructive pulmonary<br>disease (AECOPD),<br>• to aid in decision making on<br>antibiotic discontinuation for<br>patients with suspected or<br>confirmed sepsis. |
| Assay Protocol | The Elecsys BRAHMS PCT assay is a<br>two-step sandwich immunoassay with<br>streptavidin microparticles and an<br>electrochemiluminescence detection<br>system. The test system reagents contain<br>a biotinylated monoclonal PCT-specific<br>antibody and a ruthenium labeled<br>monoclonal PCT-specific antibody. | The BRAHMS PCT sensitive<br>KRYPTOR® assay is a<br>homogeneous sandwich<br>immunoassay for detection of PCT<br>in human serum or plasma. The<br>measuring principle is based on<br>Time-Resolved Amplified Cryptate<br>Emission (TRACE®) technology,<br>which measures the signal that is<br>emitted from an immunocomplex<br>with time delay. |
| Detection Protocol | Electrochemiluminescent Assay | Time-Resolved Amplified Cryptate<br>Emission (TRACE®) |
| Applications | 18-minute application | 19-minute incubation |
| Instrument Platform | cobas e 411 analyzer | BRAHMS KRYPTOR® analyzer |
| Sample Volume | 30 μL | 50 μL |
| Sample Type | Human serum and plasma (Li-Heparin,<br>K2/K3 EDTA) | Human serum and plasma (EDTA,<br>heparin) |
| Feature | Candidate Device: Elecsys BRAHMS<br>PCT | Predicate Device: B.R.A.H.M.S.<br>PCT sensitive KRYPTOR®<br>(K171338). |
| Reagents | M: Streptavidin-coated microparticles:<br>Steptavidin-coated microparticles;<br>preservative<br>R1: Anti-PCT-Ab~biotin:<br>Biotinylated monoclonal anti-PCT antibody<br>(mouse), phosphate buffer, preservative<br>R2: Anti-PCT – Ab~Ru(bpy) 2/3+ a<br>monoclonal anti-PCT antibody (mouse)<br>labeled with reuthenium complex,<br>phosphate buffer, preservative | Cryptate conjugate, cryptate<br>labeled, anti-PCT antibody<br>(polyclonal, sheep), 3.2mL after<br>reconstitution with KRYPTOR®<br>Solution 2<br>XL665 conjugate, XL665 labeled,<br>anti-PCT antipody (monoclonal,<br>mouse), 3.95 mL after<br>reconstitution with KRYPTOR®<br>Solution 1 and KRYPTOR® Solution<br>2<br>Defibrinated human plasma, for<br>diluting samples above 50µg/L,<br>ready for use |
| Calibrator | Elecsys PCT CalSet | BRAHMS PCT sensitive<br>KRYPTOR® Calibrator |
| Calibration Interval | Calibration must be performed once per<br>reagent lot using fresh reagent (i.e. not<br>more than 24 hours since the reagent kit<br>was registered on the analyzer). Renewed<br>calibration is recommended as follows:<br>• after 8 weeks when using the same<br>reagent lot<br>• after 7 days (when using the same<br>reagent kit on the analyzer) as<br>required: e.g. quality control findings<br>outside the specified limits | Before first use of each new<br>BRAHMS PCT sensitive<br>KRYPTOR® lot, then repeated on a<br>regular basis automatically<br>managed by the BRAHMS PCT<br>sensitive KRYPTOR®. |
| Controls | Precicontrol PCT | BRAHMS PCT sensitive<br>KRYPTOR® Controls |
| Traceability/ Standardization | This method has been standardized<br>against the BRAHMS PCT LIA assay. | Not Provided |
| Reagent Stability | Store at 2-8 °C. Do not freeze. Store the<br>Elecsys reagent kit upright in order to<br>ensure complete availability of the<br>microparticles during automatic mixing<br>prior to use.<br>Stability:<br>• unopened at 2-8 °C: up to the stated<br>expiration date<br>• after opening at 2-8 °C: 12 weeks<br>• on the analyzers: 4 weeks | In original shipping containers<br>unopened at 2-8 °C: up to the<br>stated expiration date<br>after opening, onboard at 2-8 °C:<br>29 days |
| Measuring Range | 0.02 - 100ng/mL | 0.02-50µg/L |
| LoB | 0.015 ng/mL | N/P |
| LoD | 0.02 ng/mL | N/P |
| Feature | Candidate Device: Elecsys BRAHMS<br>PCT…