# K012040: Ramp Myoglobin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Response Biomedical Corp.
- Decided: Dec 18, 2001 after 172 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973126 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973126: Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage Troponin-I and CK-MB, Triage Troponin-I, Biosite Incorporated (1997) Summary page 1.
- K000196: Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316, Beckman Coulter, Inc. (2000)

## Indications for use
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,

Source page: https://510kreport.com/device/K012040
Methodology: https://510kreport.com/methodology