# K973365: Aic - Chek (Hbaic-I)

- Pathway: 510(k) (Traditional)
- Applicant: Express-Med, Inc.
- Decided: Jun 15, 1998 after 280 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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.

## Most influential descendants
- K983172: Accu-Base Hemoglobin A1C Sample Collection Kit (1998), 2 descendants of its own
- K993787: Appraise-Cardio Sample Collection Kit (2000), 1 descendant of its own
- K021698: MY Allergy Test (2002), 0 descendants of its own

## Indications for use
We propose the following Indications for Use Statement. The intended use of Express-Med’s A, .-EXPRESS is for the determination of percent of hemoglobin A, in human whole blood samples. Clinically, Express-Med’s A, -EXPRESS is intended to be used as a measure of long-term glycemic control in patients with diabetes mellitus. This product will be available to patients through Point of Care offices. Preferably, A,.-EXPRESS should be used in conjunction with other diabetes management tools, including consulitation with health care professionals, goal-setting, education, exercise, diet, and, when prescribed, medication. A, -EXPRESS does not replace daily blood glucose monitoring. There are no known contraindications. The kit should be kept out of reach of children.

Source page: https://510kreport.com/device/K973365
Methodology: https://510kreport.com/methodology