510(k) Report

510(k) · Cleared

Cleared

Ramp CK-MB Assay

K033747510(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. · JHX Fluorometric Method, Cpk Or Isoenzymes

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
JHX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K970343 (1997). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestorK970343 · MMB Method · Dade Chemistry Systems, Inc. · 1997199619982000200220042006
Other ancestors, by generation 1 generation back: 1 other ancestor K970343 · MMB Method · Dade Chemistry Systems, Inc. · 19970
  1. Root · 1 generation backK970343 MMB MethodDade Chemistry Systems, Inc. · 1997
  2. This deviceK033747 Ramp CK-MB AssayResponse Biomedical Corp. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K970343MMB MethodDade Chemistry Systems, Inc.1997—
0 (this device)K033747Ramp CK-MB AssayResponse Biomedical Corp.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K033747, 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 JHX? 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 JHX device

  1. #1 K234005 Access CK-MBscore 7.2 · 2 generations · no Class I recall
  2. #2 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
…de: JHX Panel: Clinical Chemistry 3. Predicate Device Immunoassay: Triage Cardiac Panel®; CK-MB Assay (K9731 26) which is currently being marketed by Biosite Diagnostics, Inc. Immunoassay:…
Biosite Incorporated1997—
*K970343MMB Method
Summary page 1
…arketed by Biosite Diagnostics, Inc. Immunoassay: Dimensione RxL Mass Creatine Kinase MB Isoenzyme Flex®, (K970343) which is currently being marketed by Dade Behring Inc. Response Biomedical 8081 Loughe…
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 JHX devices

JHX Fluorometric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JHX

1in 2024

2009: 12012: 12017: 12022: 12024: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JHX

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

Recalls per year · JHX

2in 2015

2008: 12009: 12012: 42015: 2
2007high 4 (2012) · low 0 (2007)2026

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

Adverse event reports per year · JHX

1in 2025

2007: 22008: 62009: 402010: 272011: 42012: 182013: 82014: 172015: 82016: 102017: 32018: 162019: 72020: 32021: 102022: 22023: 22024: 22025: 1
2007high 40 (2009) · low 1 (2025)2025

MAUDE reports naming product code JHX, 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—02
20080—16
20091—140
20100—027
20110—04
20121—418
20130—08
20140—017
20150—28
20160—010
20171—03
20180—016
20190—07
20200—03
20210—010
20221—02
20230—02
20241—02
20250—01
20260—0—

What is it indicated for?

The RAMP CK-MB Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with the RAMP Clinical Reader to measure CK-MB levels in EDTA whole blood. Measurement of CK-MB aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP CK-MB Assay is not intended to monitor reperfusion patients. The RAMP CK-MB 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
  • K033745Ramp Troponin I 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
  • K033745Ramp Troponin I AssayResponse Biomedical Corp. · 2004

Recent decisions in JHX

The JHX category page

  • K234005Access CK-MBBeckman Coulter, Inc. · 2024
  • K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics · 2022
  • K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017
  • K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal CartridgeRadiometer Medical Aps · 2012
  • K081360Pathfast CK-MB-II, Pathfast Myo-IIMitsubishi Kagaku Iatron · 20091 recall

https://510kreport.com/device/K033747 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033747: Ramp CK-MB Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033747

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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