← Product Code [PRI](/submissions/MI/subpart-d%E2%80%94serological-reagents/PRI) · K171338

# B R A H M S PCT sensitive KRYPTOR (K171338)

_Brahms GmbH · PRI · May 31, 2017 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PRI/K171338

## Device Facts

- **Applicant:** Brahms GmbH
- **Product Code:** [PRI](/submissions/MI/subpart-d%E2%80%94serological-reagents/PRI.md)
- **Decision Date:** May 31, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3215
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for 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.

## Regulatory 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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: K171338

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PRI/K171338](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PRI/K171338)

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