510(k) Report

510(k) · Cleared

Cleared

Ramp Myoglobin Assay

K012040510(k) TraditionalCleared Dec 18, 2001172-day reviewClass II21 CFR 866.5680

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

Response Biomedical Corp. · DDR Myoglobin, Antigen, Antiserum, Control

Cleared on Dec 18, 2001 as substantially equivalent to K973126 (Biosite Incorporated, 1997) and 1 other predicate after a 172-day review. Its family tree reaches back 1 generation to 1997.

Decided
Dec 18, 2001
Review
172 days
Class
Class II
Product code
DDR
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K973126 (1997). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK973126 · Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage Troponin-I and CK-MB, Triage Troponin-I · Biosite Incorporated · 19971996199820002002
Other ancestors, by generation 1 generation back: 1 other ancestor K973126 · Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage Troponin-I and CK-MB, Triage Troponin-I · Biosite Incorporated · 19970
  1. Root · 1 generation backK973126 Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage…Biosite Incorporated · 1997
  2. This deviceK012040 Ramp Myoglobin AssayResponse Biomedical Corp. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K973126Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin…Biosite Incorporated1997—
0 (this device)K012040Ramp Myoglobin AssayResponse Biomedical Corp.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K012040, 1997–2001Source: 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 DDR? 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 DDR device

  1. #1 K231832 Access Myoglobinscore 6.3 · 2 generations · no Class I recall
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K973126Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage…
Summary page 1
…ame: Myoglobin immunological test system Classification Name: Myoglobin immunological test system Predicate Device: Immunoassay: Triage Cardiac Panel®; Myogiobin Assay (K973126) which is currently being marketed by Biosite Diagnostics, Inc. Immunoassay: ACCESS® Myoglobin Assay (KO00196) which is currently…
Biosite Incorporated1997—
*K000196Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316Beckman Coulter, Inc.2000—

Also cleared against K973126: 4 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?

  • None of the 2 ancestors has a recall.
  • 4 other devices also cite its predicate K973126.

How does its category compare?

All DDR devices

DDR Myoglobin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DDR

1in 2023

2009: 22012: 12013: 12023: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DDR

Too few DDR 510(k)s in any year since 2007 to give a median.

Recalls per year · DDR

2in 2015

2007: 22009: 12015: 2
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DDR

5in 2025

2009: 32011: 52012: 22013: 32014: 12016: 32017: 52018: 32019: 62020: 22021: 12022: 12023: 72024: 312025: 5
2007high 31 (2024) · low 0 (2007)2025

MAUDE reports naming product code DDR, 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
20070—20
20080—00
20092—13
20100—00
20110—05
20121—02
20131—03
20140—01
20150—20
20160—03
20170—05
20180—03
20190—06
20200—02
20210—01
20220—01
20231—07
20240—031
20250—05
20260—0—

What is it indicated for?

The RAMP Reader is a generat use fluorameter that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 T

The RAMP™ Myaglobin Assay is an immuncchromatographic test for the quantitative determination of rayoglabin in human EDTA whale blood, using the RAMP Reader,

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K973126

4 other devices cite the same predicate.

  • K040437Triage Profiler S.O.B. PanelBiosite Incorporated · 2004
  • K033747Ramp CK-MB AssayResponse Biomedical Corp. · 2004
  • K033745Ramp Troponin I AssayResponse Biomedical Corp. · 2004
  • K030286Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated · 20032 Class I recalls

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
  • K063662Ramp NT-Probnp AssayResponse Biomedical Corp. · 2008
  • K071591Ramp Influenza a/B AssayResponse Biomedical Corp. · 2008
  • K033747Ramp CK-MB AssayResponse Biomedical Corp. · 2004

Recent decisions in DDR

The DDR category page

  • K231832Access MyoglobinBeckman Coulter, Inc. · 2023
  • K123785Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories · 2013
  • K122599Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorSiemens Healthcare Diagnostics, Inc. · 20121 recall
  • K083260Elecsys Myoglobin Stat, and Elecsys MyoglobinRoche Diagnostics · 2009
  • K080481Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsBeckman Coulter, Inc. · 2009

https://510kreport.com/device/K012040 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012040: Ramp Myoglobin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012040

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026