# K033300: Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Nov 5, 2003 after 22 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973517 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984191: Myoglobin Flex Reagent Cartridge, Dade Behring, Inc. (1998) Summary page 3.
- K992349: Vitros Immunodiagnostic Products Troponin I Range Verifiers, Ortho-Clinical Diagnostics, Inc. (1999) Summary page 4.

## Recalls of this device
- Nov 29, 2018 · Class II · Z-0844-2019: A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

## Indications for use
For the in vitro quantitative measurement of myoglobin concentration in human serum or plasma (EDTA or heparin) to aid in the diagnosis of myocardial infarction. For in vitro use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of Myoglobin in human serum and plasma (EDTA or heparin). Assayed for use in verifying the calibration range of the Vitros Immunodiagnostic System when used for the measurement of Myoglobin. For in vitro use.

Source page: https://510kreport.com/device/K033300
Methodology: https://510kreport.com/methodology