B R A H M S PCT sensitive KRYPTOR

K171338 · Brahms GmbH · PRI · May 31, 2017 · Microbiology

Device Facts

• Record ID: K171338
• Device Name: B R A H M S PCT sensitive KRYPTOR
• Applicant: Brahms GmbH
• Product Code: PRI · Microbiology
• Decision Date: May 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3215
• Device Class: Class 2

Intended Use

The B-R-A-H-M-S PCT sensitive KRYPTOR® is an immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE) technology to determine the concentration of PCT (procalcitonin) in human serum and EDTA or heparin plasma. The B·R·A·H·M·S PCT sensitive KRYPTOR® is intended to be performed on the B·R·A·H·M·S KRYPTOR® analyzer family. Used in conjunction with other laboratory findings and clinical assessments, B·R·A·H·M·S PCT sensitive KRYPTOR® 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

Automated immunofluorescent assay; measures procalcitonin (PCT) in human serum/plasma using TRACE technology; performed on B·R·A·H·M·S KRYPTOR analyzer family. Input: patient serum/plasma sample; Transformation: sandwich immunoassay with sheep polyclonal and mouse monoclonal anti-PCT antibodies; Output: quantitative PCT concentration. Used in clinical labs/hospitals; operated by laboratory technicians. Healthcare providers interpret PCT levels alongside clinical signs/symptoms to guide antibiotic initiation/discontinuation and assess sepsis/mortality risk. Benefits: optimized antibiotic stewardship; reduced antibiotic exposure/duration; improved risk stratification for critically ill patients.

Clinical Evidence

Evidence includes two systematic literature reviews and meta-analyses (study-level and patient-level) of randomized controlled trials (RCTs). LRTI meta-analysis (11-13 RCTs, N=3142-4090) showed 38-51% reduction in antibiotic exposure and 2.9-day reduction in duration. Sepsis discontinuation meta-analysis (5-10 RCTs, N=598-3489) showed 23% reduction in antibiotic exposure and 1.5-day reduction in duration. No negative effects on mortality or length of stay observed.

Technological Characteristics

Homogeneous sandwich immunoassay; TRACE (Time-Resolved Amplified Cryptate Emission) technology; 19-minute assay duration. Reagents: lyophilized sheep polyclonal and mouse monoclonal anti-PCT antibodies. Sample volume: 50 µL. Connectivity: B·R·A·H·M·S KRYPTOR analyzer family. Standards: CLSI EP05-A3, EP06-A, EP07-A2, EP17-A2, EP25-A, EP21-Ed2; ISO 14971, ISO 15223-1; IEC 62304, IEC 61010-1.

Indications for Use

Indicated for critically ill patients on first day of ICU admission for risk assessment of progression to severe sepsis/septic shock; patients with severe sepsis/septic shock in ICU, ED, or medical wards for 28-day all-cause mortality risk assessment; inpatients or ED patients with suspected/confirmed LRTI (CAP, acute bronchitis, AECOPD) for antibiotic therapy decision-making; and patients with suspected/confirmed sepsis for antibiotic discontinuation decision-making. Not for use in patients <18 years, pregnant women, or immunocompromised individuals.

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.

Submission Summary (Full Text)

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May 31, 2017

Food and Drug Administration

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

B.R.A.H.M.S GMBH Bernhard Ciommer, Ph.D. Director Global RA / QA Compliance Neuendorfstrasse. 25 D-16761 Hennigsdorf Germany

Re: K171338 Trade/Device Name: B R A H M S PCT Sensitive Kryptor 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: PRI, PMT, NTM Dated: May 2, 2017 Received: May 8, 2017

Dear Dr. Ciommer:

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

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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 [phone] or [phone] 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

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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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| <b>Indications for Use</b> | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | |
| Device Name | B-R-A-H-M-S PCT sensitive KRYPTOR® |
| Indications for Use (Describe) | |
| 1. Intended Use: | |
| | The B-R-A-H-M-S PCT sensitive KRYPTOR® is an immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE) technology to determine the concentration of PCT (procalcitonin) in human serum and EDTA or heparin plasma. |
| | The B-R-A-H-M-S PCT sensitive KRYPTOR® is intended to be performed on the B·R·A·H·M·S KRYPTOR® analyzer family. |
| | Used in conjunction with other laboratory findings and clinical assessments, B·R·A·H·M·S PCT sensitive KRYPTOR® is intended for use as follows: <ul><li>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,</li><li>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,</li><li>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),</li><li>to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.</li></ul> |
| 2. Indications for use: | |
| | Same as Intended Use. |
| Type of Use (Select one or both, as applicable) | |
| | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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#### 5.0 510(K) SUMMARY

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# 510K SUMMARY

#### GENERAL INFORMATION

| Submission Date: | May 2, 2017 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Information: | |
| Submitted By: | B·R·A·H·M·S GmbH<br>Neuendorfstr. 25<br>16761 Hennigsdorf, Germany |
| Contact Person: | Sascha Johannes, PhD<br>Global Medical Affairs Manager<br>Clinical Diagnostics<br>Thermo Fisher Scientific<br>Neuendorfstr. 25<br>16761 Hennigsdorf, Germany<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

#### A. 510(k) Number:

K171338

## B. Purpose for Submission:

To obtain clearance for expanded indications for use(s) for the B.R.A.H. M.S PCT sensitive KRYPTOR®

#### C. Measurand:

Procalcitonin

# D. Type of Test:

Immunofluorescent assay

# E. Applicant:

B·R·A·H·M·S GmbH, part of Thermo Fisher Scientific

# F. Proprietary and Established Names:

B·R·A·H·M·S PCT sensitive KRYPTOR®

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## G. Regulatory Information:

- 1. Regulation section:
21 CFR 866.3215; Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis

- 2. Classification:
Class II (Special Controls)

- 3. Product codes:
PRI, PMT, NTM

- 4. Panel:
83 - (Microbiology)

# H. Intended Use:

- 1. Intended Use:
The B.R.A.H.M.S.PCT sensitive KRYPTOR® is an immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE) technology to determine the concentration of PCT (procalcitonin) in human serum and EDTA or heparin plasma.

The B·R·A·H·M·S PCT sensitive KRYPTOR® is intended to be performed on the B·R·A·H·M·S KRYPTOR® analyzer family.

Used in conjunction with other laboratory findings and clinical assessments, B.R.A.H.M.S.PCT sensitive KRYPTOR® 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

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patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) - defined as communityacquired 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.
- 2. Indications for use:

Same as Intended Use.

- 3. Special conditions for use statement(s):
For prescription use only

#### Warnings and Precautions:

- B·R·A·H·M·S PCT sensitive KRYPTOR® is not indicated to be ● used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence.
- Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations.
- PCT results should always be interpreted in the context of the ● clinical status of the patient and other laboratory results. Changes in PCT levels for the prediction of mortality, and overall mortality, are strongly dependent on many factors, including pre-existing patient risk factors and clinical course.
- The need to continue ICU care at Day 4 and other covariates (e.g., ● age and SOFA score) are also significant predictors of 28-day cumulative mortality risk.
- Certain patient characteristics, such as severity of renal failure or ● insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values.
- Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock.
- PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydophila pneumoniae and Mycoplasma pneumoniae.
- The safety and performance of PCT-guided therapy for individuals . younger than age 18 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the

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supportive clinical trials.

#### 4. Special instrument requirements:

B·R·A·H·M·S KRYPTOR® analyzer family

## I. Device Description: Reagents

Materials provided in B·R·A·H·M·S PCT sensitive KRYPTOR®

The B.R.A.H.M.S.PCT sensitive KRYPTOR® contains sufficient reagents for 50 determinations.

| Materials Provided: Reagent | Quantity for 50 determinations | Content |
|-----------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cryptate Conjugate | 1 bottle lyophilized | Cryptate conjugate,cryptate labeled, anti-<br>PCT antibody (polyclonal, sheep), 3.2<br>mL after reconstitution with KRYPTOR<br>Solution 1 and KRYPTOR Solution 2 |
| XL665 Conjugate | 1 bottle lyophilized | XL665 conjugate, XL665 labeled, anti-<br>PCT antibody (monoclonal, mouse), 3.95<br>mL after reconstitution with KRYPTOR<br>Solution 1 and KRYPTOR Solution 2 |
| Diluent | 1 bottle | Defibrinated human plasma, for diluting<br>samples above 50 μg/L, ready for use |

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#### Additional materials required but not provided with the B·R·A·H·M·S PCT sensitive KRYPTOR:

| B·R·A·H·M·S PCT sensitive KRYPTOR® Calibrator | |
|-----------------------------------------------|--|
| | |

| Content | |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibrator | Lyophilized recombinant PCT in defibrinated human<br>plasma, reconstitute with 0.75 mL de-ionized water<br>with conductivity of less than 50 μS/cm [range: 22.5 –<br>27.5 μg/L] |

#### B·R·A·H·M·S PCT sensitive KRYPTOR® Controls

| Content | |
|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Control 1 | PCT control 1, lyophilized recombinant PCT in<br>defibrinated human plasma, reconstitute with 2 mL de-<br>ionized water with conductivity of less than 50 µS/cm<br>[range: 0.2 – 0.4 µg/L] |
| Control 2 | PCT control 2, lyophilized recombinant PCT in<br>defibrinated human plasma, reconstitute with 2 mL de-<br>ionized water with conductivity of less than 50 µS/cm<br>[range: 8 - 12 µg/L] |

# KRYPTOR® Consumables

| Content | |
|--------------------|----------------------------------------------------------------------------------------|
| KRYPTOR Solution 1 | ProClin 150 Solution |
| KRYPTOR Solution 2 | Potassium fluoride solution |
| KRYPTOR Solution 3 | Active chlorine and sodium hydroxide solution |
| KRYPTOR Solution 4 | Sodium hydroxide solution |
| KRYPTOR BUFFER | Phosphate Buffer Saline (PBS) buffer, not reconstituted, 5 liters after reconstitution |

- Reaction plates KRYPTOR® ●
- Dilution plates KRYPTOR® ●

# J. Substantial Equivalence Information:

- 1. Predicate device name(s):
B·R·A·H·M·S PCT sensitive KRYPTOR®

VIDAS B·R·A·H·M·S PCT (PCT)

- 2. Predicate 510(k) number(s):
DEN150009 K162827

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## 3. Comparison with predicate:

| Item | Subject Device:<br>B·R·A·H·M·S PCT<br>sensitive KRYPTOR® | Predicate Device:<br>DEN150009<br>B·R·A·H·M·S PCT<br>sensitive KRYPTOR® | Predicate Device:<br>K162827<br>VIDAS B·R·A·H·M·S<br>PCT (PCT) |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>and<br>Indications<br>for Use | The B·R·A·H·M·S<br>PCT sensitive<br>KRYPTOR® is an<br>immunofluorescent<br>assay using Time-<br>Resolved Amplified<br>Cryptate Emission<br>(TRACE) technology<br>to determine the<br>concentration of PCT<br>(procalcitonin) in<br>human serum and<br>EDTA or heparin<br>plasma.<br>The B·R·A·H·M·S<br>PCT sensitive<br>KRYPTOR® is<br>intended to be<br>performed on the<br>B·R·A·H·M·S<br>KRYPTOR® analyzer<br>family.<br>Used in conjunction<br>with other laboratory<br>findings and clinical<br>assessments,<br>B·R·A·H·M·S PCT<br>sensitive KRYPTOR®<br>is intended for use as<br>follows:<br>• to aid in the risk<br>assessment of<br>critically ill patients<br>on their first day of<br>ICU admission for<br>progression to severe<br>sepsis and septic<br>shock,<br>• to determine the<br>change in PCT level | The B•R•A•H•M•S PCT<br>sensitive KRYPTOR® is<br>an immunofluorescent<br>assay using Time-<br>Resolved Amplified<br>Cryptate Emission<br>(TRACE) technology to<br>determine the<br>concentration of PCT<br>(procalcitonin) in human<br>serum and EDTA or<br>heparin plasma.<br>The B•R•A•H•M•S PCT<br>sensitive KRYPTOR® is<br>intended to be performed<br>on the B·R·A·H·M·S<br>KRYPTOR® analyzer<br>family.<br>The B•R•A•H•M•S PCT<br>sensitive KRYPTOR® is<br>intended for use in<br>conjunction with other<br>laboratory findings and<br>clinical assessments to aid<br>in the risk assessment of<br>critically ill patients on<br>their first day of Intensive<br>Care Unit (ICU) admission<br>for progression to severe<br>sepsis and septic shock.<br>The B•R•A•H•M•S PCT<br>sensitive KRYPTOR® is<br>also intended for use to<br>determine the change in<br>PCT level over time as an<br>aid in assessing the<br>cumulative 28-day risk of<br>all-cause mortality in<br>conjunction with other<br>laboratory findings and<br>clinical assessments for | VIDAS B·R·A·H·M·S PCT<br>(PCT) is an automated test<br>for use on the instruments<br>of the VIDAS family for<br>the determination of human<br>procalcitonin in human<br>serum or plasma (lithium<br>heparinate) using the ELFA<br>(Enzyme-Linked<br>Fluorescent Assay)<br>technique.<br>Used in conjunction with<br>other laboratory findings<br>and clinical assessments,<br>VIDAS B•R•A•H•M•S<br>PCT (PCT) is intended for<br>use as follows:<br>• to aid in the risk<br>assessment of critically<br>ill patients on their first<br>day of ICU admission<br>for progression to<br>severe sepsis and septic<br>shock,<br>• to aid in assessing the<br>cumulative 28-day risk<br>of all-cause mortality<br>for patients diagnosed<br>with severe sepsis or<br>septic shock in the ICU<br>or when obtained in the<br>emergency department<br>or other medical wards<br>prior to ICU admission,<br>using a change in PCT<br>level over time,<br>• to aid in decision<br>making on antibiotic<br>therapy for inpatients<br>with suspected or |
| Item | Subject Device:<br>B·R·A·H·M·S PCT<br>sensitive KRYPTOR® | Predicate Device:<br>DEN150009<br>B·R·A·H·M·S PCT<br>sensitive KRYPTOR® | Predicate Device:<br>K162827<br>VIDAS B·R·A·H·M·S<br>PCT (PCT) |
| | • in assessing the<br>cumulative 28-day<br>risk of all-cause<br>mortality for patients<br>diagnosed with<br>severe sepsis or<br>septic shock in the<br>ICU or when<br>obtained in the<br>emergency<br>department or other<br>medical wards prior<br>to ICU admission,<br>• to aid in decision<br>making on antibiotic<br>therapy, for<br>inpatients or patients<br>in the emergency<br>department with<br>suspected or<br>confirmed lower<br>respiratory tract<br>infections (LRTI) –<br>defined as<br>community-acquired<br>pneumonia (CAP),<br>acute bronchitis, and<br>acute exacerbation<br>of chronic<br>obstructive<br>pulmonary disease<br>(AECOPD),<br>• to aid in decision<br>making on antibiotic<br>discontinuation for<br>patients with<br>suspected or<br>confirmed sepsis. | patients diagnosed with<br>severe sepsis or septic<br>shock in the ICU or when<br>obtained in the emergency<br>department or other<br>medical wards prior to<br>ICU admission.<br>Procalcitonin (PCT) is a<br>biomarker associated with<br>the inflammatory response<br>to bacterial infection that<br>aids in the risk assessment<br>of critically ill patients on<br>their first day of Intensive<br>Care Unit (ICU) admission<br>for progression to severe<br>sepsis and septic shock.<br>The percent change in<br>PCT level over time also<br>aids in the prediction of<br>cumulative 28-day<br>mortality in patients with<br>severe sepsis and septic<br>shock.<br>PCT level on the first day<br>of ICU admission above<br>2.0 $μ$ g/L is associated with<br>a higher risk for<br>progression to severe<br>sepsis and/or septic shock<br>than a PCT level below 0.5<br>$μ$ g/L.<br>A PCT level that declines<br>≤ 80% from the day that<br>severe sepsis or septic<br>shock was clinically<br>diagnosed (Day 0) to four<br>days after clinical<br>diagnosis (Day 4) is<br>associated with higher<br>cumulative 28-day risk of<br>all-cause mortality than a<br>decline > 80%. | respiratory tract<br>infections (LRTI)<br>defined as community-<br>acquired pneumonia<br>(CAP), acute bronchitis,<br>and acute exacerbation<br>of Chronic Obstructive<br>Pulmonary Disease<br>(AECOPD) – in an<br>inpatient setting or an<br>emergency department;<br>• to aid in decision<br>making on antibiotic<br>discontinuation for<br>patients with suspected<br>or confirmed sepsis. |
| Item | Subject Device:<br>B·R·A·H·M·S PCT<br>sensitive KRYPTOR® | Predicate Device:<br>DEN150009<br>B·R·A·H·M·S PCT<br>sensitive KRYPTOR® | Predicate Device:<br>K162827<br>VIDAS B·R·A·H·M·S<br>PCT (PCT) |
| Specimen | Human serum and<br>plasma (EDTA,<br>heparin) | Same | Human serum or plasma<br>(lithium heparinate). |
| Analyte | Procalcitonin (PCT) | Same | Procalcitonin (PCT) |
| Automated | Automated assay | Same | Automated assay |
| Assay<br>Technique | TRACE® technology | Same | ELFA (Enzyme-Linked<br>Fluorescent Assay)<br>technique. |
| Assay<br>principle | Two antibody<br>"sandwich" binding of<br>Procalcitonin. | Same | Immunoassay based on<br>sandwich principle |
| Detection<br>method | Time-Resolved<br>Amplified Cryptate<br>Emission (TRACE®) | Same | Fluorescence (ELFA) of 4-<br>methyl-umbelliferyl<br>measured at 450 nm |
| Assay<br>duration | 19 minutes | Same | Approximately 20 minutes |
| Combination<br>devices | B·R·A·H·M·S<br>KRYPTOR® analyzer<br>family | Same | Instruments of the VIDAS<br>family: VIDAS,<br>miniVIDAS or VIDAS 2 |
| Item | Subject Device:<br>B·R·A·H·M·S PCT<br>sensitive KRYPTOR® | Predicate Device:<br>DEN150009<br>B·R·A·H·M·S PCT<br>sensitive KRYPTOR®…