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K Number
K051787
Device Name
TRIAGE BNP TEST, MODEL 98000XR
Manufacturer
BIOSITE INCORPORATED
Date Cleared
2005-09-22

(83 days)

Product Code
NBC
Regulation Number
862.1117
Type
Traditional
Panel
CH
Reference & Predicate Devices
K021317,K032646
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Triage® BNP Test is a rapid, point of care fluorescence immunoassay to be used with the Triage Meter or Triage MeterPlus for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in EDTA anticoagulated whole blood or plasma specimens. The test is intended to be used as an aid in the:

  • Diagnosis of heart failure .
  • Assessment of heart failure severity of .
  • Risk stratification of patients with acute coronary syndromes .
  • Risk stratification of patients with heart failure .
Device Description

The Triage BNP Test is a rapid, point of care fluorescence immunoassay to be used with the Triage Meters for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in EDTA anticoagulated whole blood or plasma specimens.

AI/ML Overview

The provided text, K051787, does not contain the detailed study information needed to fully address your request in the format you've outlined. This document is primarily a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting comprehensive performance study data with acceptance criteria.

Specifically, the document does not contain:

  • A table of acceptance criteria and reported device performance.
  • Information on sample sizes for test sets, data provenance, or details about ground truth establishment for a test set.
  • The number or qualifications of experts used to establish ground truth.
  • Adjudication methods.
  • Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including an effect size.
  • Standalone algorithm performance (as this is a point-of-care fluorescence immunoassay, not an AI algorithm in the conventional sense of image or signal processing).
  • The sample size for a training set or how ground truth was established for a training set.

The document states:

  • Device Name: Triage® BNP Test
  • Intended Use: Quantitative measurement of B-Type Natriuretic Peptide (BNP) in EDTA anticoagulated whole blood or plasma specimens, to be used as an aid in the:
    • Diagnosis of heart failure.
    • Assessment of heart failure severity.
    • Risk stratification of patients with acute coronary syndromes.
    • Risk stratification of patients with heart failure.
  • Predicate Devices: Biosite Triage BNP Test (K021317) and Roche Elecsys ProBNP Immunoassay (K032646).
  • Basis for Clearance: Substantial equivalence to predicate methods, stating, "The device and test method described in this premarket notification is identical in principle, reagents and procedure to the currently marketed Triage BNP Test (K021317)."

To provide the information you requested, a more detailed study report (e.g., a clinical study report or validation study) from Biosite Incorporated would be necessary. The 510(k) summary focuses on regulatory approval based on equivalence rather than exhaustive performance study details as might be found for a novel AI-powered diagnostic.

§ 862.1117 B-type natriuretic peptide test system.

(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”