510(k) · Cleared
Recalled · Class II · 2018Vitros Immunodiagnostic Products NT Pro-BNP Reagent Pack,Calibrators,Range Verifiers,680 2156,680 2157,680 2158
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · NBC Test, Natriuretic Peptide
Cleared on Jun 6, 2006 as substantially equivalent to K051382 (Roche Diagnostics Corp., 2005) and 1 other predicate after an 89-day review. Its family tree reaches back 4 generations to 2000. It has been recalled 2 times.
- Decided
- Jun 6, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- NBC
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN000010 (2000). 6 ancestors in all, the oldest K973517 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
- 3 generations backK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
- 2 generations backK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
- 1 generation backK051382 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2005
- This deviceK060632 Vitros Immunodiagnostic Products NT Pro-BNP Reagent…Ortho-Clinical Diagnostics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2000 | — |
| −3 | K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2002 | — |
| −2 | K032646 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| −1 | K051382 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2005 | — |
| 0 (this device) | K060632 | Vitros Immunodiagnostic Products NT Pro-BNP Reagent Pack,Calibrators,Range… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NBC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NBC device
- #1 K262109 Access NT-proBNPscore 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051382 | Elecsys Probnp ImmunoassaySummary page 2…ck, VITROS Immunodiagnostic Product NT-proBNP Calibrators are substantially equivalent to the Roche Elecsys® proBNP Inmunoassay K051382. The VITROS Immunodiagnostic Products NT-proBNP Range Verifiers are substantially equivalent to the… | 2005 |
| * | K990984 | Vitros Immunodiagnostic Products Cea Range VerifiersSummary page 2…ts NT-proBNP Range Verifiers are substantially equivalent to the VITROS Immunodiagnostic Product CEA Range Verifiers previously cleared under K990984. 5 Device Description The VITROS Immunodiagnostic System uses luminescence as the signal… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2018 | Class II | Z-0689-2019 | Device Design | 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 indicated in the current Instructions for Use. |
| Mar 7, 2017 | Class II | Z-1765-2017 | Nonconforming Material/Component | 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 been increasing with time since… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K051382.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBC
126in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBC
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NBC
17in 2025
MAUDE reports naming product code NBC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 17 |
| 2008 | 7 | 126 | 0 | 15 |
| 2009 | 0 | — | 0 | 35 |
| 2010 | 1 | — | 1 | 61 |
| 2011 | 0 | — | 0 | 53 |
| 2012 | 0 | — | 2 | 23 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 1 | 70 |
| 2015 | 0 | — | 1 | 43 |
| 2016 | 0 | — | 0 | 31 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 1 | 6 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 26 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 17 |
| 2026 | 4 | 94 | 0 | — |
What is it indicated for?
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…
Read the full statement (170 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060632: Vitros Immunodiagnostic Products NT Pro-BNP Reagent Pack,Calibrators,Range Verifiers,680 2156,680 2157,680 2158.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060632
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026