510(k) Report

510(k) · Cleared

Cleared

Ramp Troponin I Assay

K033745510(k) TraditionalCleared May 17, 2004168-day reviewClass II21 CFR 862.1215

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

Response Biomedical Corp. · MMI Immunoassay Method, Troponin Subunit

Cleared on May 17, 2004 as substantially equivalent to K973126 (Biosite Incorporated, 1997) and 1 other predicate after a 168-day review. Its family tree reaches back 1 generation to 1997.

Decided
May 17, 2004
Review
168 days
Class
Class II
Product code
MMI
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 1997: 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 · 1997199619982000200220042006
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 deviceK033745 Ramp Troponin I AssayResponse Biomedical Corp. · 2004
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)K033745Ramp Troponin I AssayResponse Biomedical Corp.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K033745, 1997–2004Source: 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 MMI? 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 MMI device

  1. #1 K253051 i-STAT hs-TnI cartridge with the i-STAT…score 13.0 · 6 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? (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
…MMI Panel: Clinical Chemistry 3. Predicate Device Immunoassay: Triage Cardiac Panel®; Troponin I Assay (K973126) which is currently being marketed by Biosite Diagnostics, Inc. Immunoassa…
Biosite Incorporated1997—
*K973650Troponin (Trop) Method
Summary page 1
…currently being marketed by Biosite Diagnostics, Inc. Immunoassay: Dimension® RxL Cardiac Troponin-I Flex®, (K973650) which is currently being marketed by Dade Behring Inc. Response Biomedical 8081 Lou…
Dade Chemistry Systems, Inc.1997—

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 MMI devices

MMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MMI

4in 2025

2007: 32008: 12009: 12010: 22011: 12013: 22017: 12018: 42019: 32021: 12022: 12023: 32024: 22025: 42026 (partial year): 1
2007high 4 (2018) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMI

266in 2025

2007: 190 days median2018: 344 days median2019: 88 days median2023: 270 days median2025: 266 days median
2007high 344 (2018) · low 88 (2019)2026

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

Recalls per year · MMI

1in 2024

2007: 62008: 22009: 32010: 52011: 12012: 62014: 12015: 12019: 12020: 12021: 12024: 1
2007high 6 (2007) · low 0 (2013)2026

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

Adverse event reports per year · MMI

805in 2025

2007: 3522008: 8372009: 1,0102010: 1,3352011: 2,4062012: 1,8412013: 1,3942014: 1,1502015: 8312016: 4872017: 6182018: 4872019: 5212020: 3872021: 3562022: 5072023: 7482024: 9212025: 805
2007high 2,406 (2011) · low 352 (2007)2025

MAUDE reports naming product code MMI, 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
200731906352
20081—2837
20091—31,010
20102—51,335
20111—12,406
20120—61,841
20132—01,394
20140—11,150
20150—1831
20160—0487
20171—0618
201843440487
20193881521
20200—1387
20211—1356
20221—0507
202332700748
20242—1921
202542660805
20261—0—

What is it indicated for?

The RAMP Troponin I Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with the RAMP Clinical Reader to measure cardiac troponin I levels in EDTA whole blood. Measurement of cardiac troponin I aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP Troponin I Assay is intended to be used only to prioritize patient management for those suspected of AMI.

Indications for use as stated in the FDA summary.

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
  • K030286Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated · 20032 Class I recalls
  • K012040Ramp Myoglobin AssayResponse Biomedical Corp. · 2001

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 MMI

The MMI category page

  • K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc. · 2026
  • K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 2025
  • K243483Access hsTnIBeckman Coulter, Inc. · 2025
  • K242870Access hsTnIBeckman Coulter, Inc. · 2025
  • K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025

https://510kreport.com/device/K033745 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033745: Ramp Troponin I Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033745

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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