(89 days)
VITROS Immunodiagnostics NT-proBNP Reagent Pack: For the in vitro quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.
VITROS Immunodiagnostic Products NT-proBNP Calibrator For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin).
VITROS Immunodiagnostic Products NT-proBNP Range Verifiers For the in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP).
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of there main elements: The VITROS Immunodiagnostic Products range of immunoassay products in this case the VITROS Immunodiagnostic Products NTproBNP Reagent Pack, the VITROS Immunodiagnostic Products NT-proBNP Calibrators, and the VITROS Immunodiagnostic Products NT-proBNP Range Verifiers (which are combined by the VITROS Immunodiagnostic system to perform the VITROS NTproBNP assay) and VITROS Immunodiagnostic Products High Sample Diluent B. The VITROS Immunodiagnostic System -- instrumentation, which provides automated use of the immunoassay kits. Common reagents used by the VITROS System in each assay.
The provided document is a 510(k) summary for the VITROS Immunodiagnostic Products NT-proBNP Reagent Pack, Calibrator, and Range Verifier. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results for novel device performance.
Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical performance study for an AI-powered device. Instead, it relies on demonstrating comparable performance to an already cleared predicate device.
Here's a breakdown of why the requested information cannot be fully provided from this document:
- No explicit acceptance criteria or performance study for device novelty: Since this is a substantial equivalence submission for an in vitro diagnostic (IVD) device, the "acceptance criteria" are implicitly met by demonstrating that the new device's performance characteristics (e.g., measuring range, analytical sensitivity, functional sensitivity, intended use) are substantially equivalent to a legally marketed predicate device. There isn't an independent study outlined to "prove" the device meets specific (novel) acceptance criteria, but rather a comparison to an established device.
- No AI component: This device is an immunoassay system for measuring NT-proBNP, not an AI-powered diagnostic tool. Therefore, questions related to AI-specific elements (like test sets, training sets, adjudication, MRMC studies, or standalone algorithm performance) are not applicable.
Despite these limitations, I can extract and infer some information based on the comparison tables provided.
Inferred Acceptance Criteria and Reported Device Performance (Based on Predicate Device Comparison)
The acceptance criteria for this device are implicitly tied to demonstrating performance comparable to the predicate device (Roche Elecsys proBNP Immunoassay K051382 for the Reagent Pack and Calibrator, and VITROS Immunodiagnostic Products CEA Range Verifiers K990984 for the Range Verifiers).
| Acceptance Criteria (Inferred from Predicate Equivalence) | Target/Predicate Performance (Roche Elecsys proBNP Immunoassay K051382) | Reported Device Performance (VITROS NT-proBNP Reagent Pack) |
|---|---|---|
| Intended Use | Aid in diagnosis of CHF, risk stratification for ACS/CHF, assessment of increased risk of cardiovascular events/mortality in stable CAD, assessment of HF severity. | Substantially similar Intended Use. |
| Basic principle | Electrochemiluminescence Immunoassay | Chemiluminescence Immunoassay |
| Antibody | Biotinylated polyclonal anti-NT-proBNP (sheep) | Biotinylated polyclonal anti-NT-proBNP (sheep) |
| Instrumentation | Elecsys family of analyzers (1010, 2010, Modular Analytics) | ECI/ECIQ Immunodiagnostic System |
| Sample type | Human serum and plasma | Human serum and plasma (EDTA and heparin) |
| Expected Values | Age and sex-related statistics. Cut-offs: =75 years: 450 pg/mL. | Substantially similar. |
| Measuring Range | 5-35,000 pg/mL | 5.00-35,000 pg/mL |
| Hook Effect | No high dose hook effect up to 300,000 pg/mL | No high dose hook effect up to 500,000 pg/mL |
| Analytical Sensitivity | 5 pg/mL |
§ 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.”