# K100304: ST Aia Pack HBA1C

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Aug 27, 2010 after 205 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972265 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011434: G7 Automated HPLC Analyzer, Tosoh Medics, Inc. (2001) Summary page 2.

## Recalls of this device
- Jun 6, 2018 · Class II · Z-2745-2018: HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on thei
- Mar 5, 2018 · Class II · Z-1810-2018: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
- Mar 5, 2018 · Class II · Z-1812-2018: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
- Mar 5, 2018 · Class II · Z-1809-2018: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

## Indications for use
ST AlA-PACK HbAlc is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement for percent concentration of Hemoglobin A1c (HbAlc) in EDTA whole blood on Tosoh AlA System Analyzer. HbAlc measurement is used in the management and treatment of diabetes. The ST AlA-PACK HbAlc CALIBRATOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of ST AlA-PACK HbAlc Assay. The AlA-PACK HbAlc CONTROL SET is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AlA-PACK HbAlc Assay. The ST AlA-PACK HbAlc PRETREATMENT SOLUTION is intended for IN VITRO DIAGNOSTIC USE ONLY for the pretreatment of the patient samples or AlA-PACK HbAlc CONTROL SET for the ST AlA-PACK HbA1lc assay.

Source page: https://510kreport.com/device/K100304
Methodology: https://510kreport.com/methodology