VITROS BRAHMS PCT Reagent Pack and Calibrators

K200236 · Ortho Clinical Diagnostics · PMT · Feb 25, 2020 · Microbiology

Device Facts

• Record ID: K200236
• Device Name: VITROS BRAHMS PCT Reagent Pack and Calibrators
• Applicant: Ortho Clinical Diagnostics
• Product Code: PMT · Microbiology
• Decision Date: Feb 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3215
• Device Class: Class 2

Indications for Use

For in-vitro diagnostic use only. For the quantitative measurement of procalcitonin (PCT) in human serum and plasma (lithium heparin and EDTA) using the VITROS 3600 Immunodiagnostic System. Used in conjunction with other laboratory findings and clinical assessments, the VITROS B R A PA - M S PCT test is intended for use as follows: · to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, · to aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, using a change in PCT level over time, · to aid in decision making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) - in an inpatient setting or an emergency department, · to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

Device Story

In-vitro diagnostic assay for quantitative measurement of procalcitonin (PCT) in human serum/plasma; performed on VITROS 3600 Immunodiagnostic System. Uses two-step dual monoclonal immunometric assay; biotinylated anti-PCT antibody binds to streptavidin-coated microwell; HRP-labeled anti-PCT antibody conjugate binds to antigen; luminescent reaction catalyzed by HRP produces light signal proportional to PCT concentration. Used in clinical settings (ICU, ED, wards) by laboratory personnel. Output aids clinicians in assessing sepsis progression, 28-day mortality risk, and antibiotic therapy management. Benefits include objective data for antibiotic stewardship and patient risk stratification.

Clinical Evidence

Clinical performance evaluated using retrospective samples from the MOSES Study (n=858). Concordance with predicate method (n=2168) showed >97% agreement at clinical decision points (0.1, 0.25, 0.5, 2.0 ng/mL). Mortality risk assessment (n=598) showed significant association between ΔPCT and 28-day all-cause mortality (Fisher's exact p=0.006). Hazard ratio for ΔPCT (decline ≤80% vs >80%) was 1.93 (95% CI 1.19-3.12).

Technological Characteristics

Two-step dual monoclonal immunometric assay. Materials: rat monoclonal anti-PCT antibody, HRP-conjugated mouse monoclonal anti-PCT antibody, bovine gamma globulin, bovine serum albumin. Sensing: chemiluminescent detection of HRP-catalyzed luminol oxidation. Dimensions/Form: Reagent pack for VITROS 3600 system. Connectivity: System-integrated. Sterilization: N/A (reagent). Algorithm: Quantitative threshold-based interpretation.

Indications for Use

Indicated for critically ill patients (ICU admission) for sepsis risk assessment; patients with severe sepsis or septic shock for 28-day mortality risk assessment; and patients with suspected/confirmed lower respiratory tract infections (CAP, acute bronchitis, AECOPD) or sepsis for antibiotic therapy/discontinuation decision-making. Not for use as a stand-alone diagnostic. Safety/performance not established for <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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION MEMORANDUM

510(k) Number: K200236

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.