# K012820: Aia-Pack Ctni 2ND-Gen Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Dec 14, 2001 after 113 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- 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-2073-2018: 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 cTnl 2nd-Gen is designated for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of cardiac troponin | (cTnl) in human heparinized plasma on specific TOSOH AIA System analyzers. Cardiac troponin | measurements are used as an aid in the diagnosis of acute myocardial infarction (AMI).

Source page: https://510kreport.com/device/K012820
Methodology: https://510kreport.com/methodology