# K153417: ST AIA-PACK PROG III Calibrator Set

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Dec 18, 2015 after 23 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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: 1 generation back to K933269 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933269: Aia-Pack (R) Prog Assay, Tosoh Medics, Inc. (1993) Summary page 5.

## Recalls of this device
- Jun 7, 2016 · Class III · Z-2282-2016: Instructions For Use had incorrect lot number and calibrator values

## Indications for use
The ST AIA-PACK PROG III Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG III assay.

Source page: https://510kreport.com/device/K153417
Methodology: https://510kreport.com/methodology