# K981012: Aia-Pack Myoglobin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: May 28, 1998 after 71 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Mar 5, 2018 · Class II · Z-2072-2018: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

## Indications for use
AIA-PACK Myoglobin is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of myoglobin in human serum and plasma on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis and monitoring of cardiac disease.

Source page: https://510kreport.com/device/K981012
Methodology: https://510kreport.com/methodology