# K952720: Aalto Scientific LTD. Glycated Hemoglobin Control Levels I & II

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Sep 20, 1995 after 97 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041635: G5 I HBA1C Test, G5 II HBA1C Test (2004), 1 descendant of its own
- K081269: Avie A1C Test System (2009), 0 descendants of its own

## Recalls of this device
- Oct 5, 2021 · Class III · Z-0350-2023: The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 
- Oct 5, 2021 · Class III · Z-0349-2023: The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analy
- Aug 18, 2005 · Not classified · Z-0131-06: The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results.

Source page: https://510kreport.com/device/K952720
Methodology: https://510kreport.com/methodology