# K060632: Vitros Immunodiagnostic Products NT Pro-BNP Reagent Pack,Calibrators,Range Verifiers,680 2156,680 2157,680 2158

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jun 6, 2006 after 89 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN000010 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051382: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2005) Summary page 2.
- K990984: Vitros Immunodiagnostic Products Cea Range Verifiers, Ortho-Clinical Diagnostics, Inc. (1999) Summary page 2.

## Recalls of this device
- Nov 1, 2018 · Class II · Z-0689-2019: The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicate
- Mar 7, 2017 · Class II · Z-1765-2017: Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have

## Indications for use
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).

Source page: https://510kreport.com/device/K060632
Methodology: https://510kreport.com/methodology