510(k) Report

510(k) · Cleared

Cleared

Ramp NT-Probnp Assay

K063662510(k) TraditionalCleared Jul 21, 2008591-day reviewClass II21 CFR 862.1117

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Response Biomedical Corp. · NBC Test, Natriuretic Peptide

Cleared on Jul 21, 2008 as substantially equivalent to K022516 (Roche Diagnostics Corp., 2002) and 3 other predicates after a 591-day review. Its family tree reaches back 4 generations to 2000.

Decided
Jul 21, 2008
Review
591 days
Class
Class II
Product code
NBC
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to DEN000010 (2000). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestorDEN000010 · Triage B-Type Natriuretic Peptide (BNP) Test · Biosite Incorporated · 2000K022516 · Elecsys Probnp Immunoassay · Roche Diagnostics Corp. · 2002K032646 · Elecsys Probnp Immunoassay · Roche Diagnostics Corp. · 2003K051382 · Elecsys Probnp Immunoassay · Roche Diagnostics Corp. · 2005200020022004200620082010
Other ancestors, by generation 1 generation back: 1 other ancestor K051382 · Elecsys Probnp Immunoassay · Roche Diagnostics Corp. · 2005K032646 · Elecsys Probnp Immunoassay · Roche Diagnostics Corp. · 2003K022516 · Elecsys Probnp Immunoassay · Roche Diagnostics Corp. · 2002DEN000010 · Triage B-Type Natriuretic Peptide (BNP) Test · Biosite Incorporated · 20000
  1. Root · 4 generations backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
  2. 3 generations backK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
  3. 2 generations backK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
  4. 1 generation backK051382 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2005
  5. This deviceK063662 Ramp NT-Probnp AssayResponse Biomedical Corp. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4DEN000010Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated2000—
−3K022516Elecsys Probnp ImmunoassayRoche Diagnostics Corp.2002—
−2K032646Elecsys Probnp ImmunoassayRoche Diagnostics Corp.2003—
−1K051382Elecsys Probnp ImmunoassayRoche Diagnostics Corp.2005—
0 (this device)K063662Ramp NT-Probnp AssayResponse Biomedical Corp.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K063662, 2000–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K262109 Access NT-proBNPscore 13.8 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K022516Elecsys Probnp Immunoassay
Summary page 1
…ode: NBC Panel: Clinical Chemistry (75) 3. Predicate Device: Immunoassay: Elecsys® proBNP, (K022516, K032646, K051382) which is currently marketed by Roche Diagnostics GmbH. Imm…
Roche Diagnostics Corp.2002—
*K032646Elecsys Probnp Immunoassay
Summary page 1
…NBC Panel: Clinical Chemistry (75) 3. Predicate Device: Immunoassay: Elecsys® proBNP, (K022516, K032646, K051382) which is currently marketed by Roche Diagnostics GmbH. Immunoassay:…
Roche Diagnostics Corp.2003—
*K051382Elecsys Probnp Immunoassay
Summary page 1
…NBC Panel: Clinical Chemistry (75) 3. Predicate Device: Immunoassay: Elecsys® proBNP, (K022516, K032646, K051382) which is currently marketed by Roche Diagnostics GmbH. Immunoassay:…
Roche Diagnostics Corp.2005—
*K051596Statusfirst CHF (Congestive Heart Failure) NT-Probnp, Model 20204
Summary page 1
…1382) which is currently marketed by Roche Diagnostics GmbH. Immunoassay: StatusFirstTM CHF NT-proBNP (K051596), which is currently marketed by Nanogen, Inc.…
Nanogen, Inc.2006—

Also cleared against K022516: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • None of the 5 ancestors has a recall.
  • 8 other devices also cite its predicate K022516.

How does its category compare?

All NBC devices

NBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · NBC

1in 2025

2007: 22008: 72010: 12020: 12021: 22022: 12023: 22024: 12025: 12026 (partial year): 4
2007high 7 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBC

126in 2008

2008: 126 days median2026 (partial year): 94 days median
2007high 126 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NBC

1in 2020

2010: 12012: 22014: 12015: 12018: 12020: 1
2007high 2 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NBC

17in 2025

2007: 172008: 152009: 352010: 612011: 532012: 232013: 132014: 702015: 432016: 312017: 92018: 72019: 92020: 62022: 42023: 262024: 142025: 17
2007high 70 (2014) · low 0 (2021)2025

MAUDE reports naming product code NBC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—017
20087126015
20090—035
20101—161
20110—053
20120—223
20130—013
20140—170
20150—143
20160—031
20170—09
20180—17
20190—09
20201—16
20212—00
20221—04
20232—026
20241—014
20251—017
20264940—

What is it indicated for?

The RAMP NT-proBNP Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used to measure N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in EDTA whole blood. Measurement of NT-proBNP aids in the diagnosis and assessment of severity in individuals suspected of having heart failure and may aid in the risk stratification of patients with heart failure.

Indications for use as stated in the FDA summary.

Also cleared against K022516

8 other devices cite the same predicate.

  • K073091Vidas NT-Probnp Assay, Model: 30 449bioMerieux, Inc. · 20081 recall
  • K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
  • K061795Dimension Vista PBNP Flex Reagent Cartridge and CalibratorDade Behring, Inc. · 2006
  • K051382Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2005
  • K043476Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak DiluentDade Behring, Inc. · 20052 recalls
  • K042347Modification to Dimension NT-Probnp Flex Reagent Cartridge MethodDade Behring, Inc. · 2004

More from Response Biomedical Corp.

7 FDA decisions under this applicant name. See the company

  • K093116Modification to: Ramp Influenza a/B AssayResponse Biomedical Corp. · 2009
  • K091235Ramp RSV AssayResponse Biomedical Corp. · 2009
  • K071591Ramp Influenza a/B AssayResponse Biomedical Corp. · 2008
  • K033747Ramp CK-MB AssayResponse Biomedical Corp. · 2004
  • K033745Ramp Troponin I AssayResponse Biomedical Corp. · 2004

Recent decisions in NBC

The NBC category page

  • K262597Access BNP IIBeckman Coulter, Inc. · 2026
  • K262109Access NT-proBNPBeckman Coulter, Inc. · 2026
  • K252169Access BNP IIBeckman Coulter, Inc. · 2026
  • K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd. · 2026
  • K241176Alere NT-proBNP for Alinity i Reagent KitAxis-Shield Diagnostics, Ltd. · 2025

https://510kreport.com/device/K063662 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063662: Ramp NT-Probnp Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063662

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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