# K013465: Accu-Base Hemoglobin A1C Sample Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diabetes Technologies, Inc.
- Decided: Jan 22, 2002 after 96 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.
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.

## Indications for use
The intended use of the AccuBase A, Test Kit is for the determinatioa of the relative percent (%) A,, (glyochemozlabin) in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC) as the analytical method. The AccuBase A, Test Kit will be available to diabetes paticats through physicians, pharmacies, diabetes supply and/or OTC distribution companies for the purpose of monitaring the average glucose concentration in the body over the past 30, 60 or 90 days including; 2 calculated Mean Blood Glucose (MBG) determination based on the DCCT MBG equatica (31.7 X Ay % - 66.1) = MBG mg/d! as part of an comprehensive individual diabetes cutcomes managemeat, glycemic status assessment and reatrment program. The AccuBasc A, Test Kit does nat replace daily blood glucose monitoring. While there are no known contraindications, it is well known that the existence of disturbed erythrocyte kinetics conditions (such as anemia) many result in a non-reportable test result duc to too few Red Blood cells per volume of sample. A list of poteatial canfounding factors are reparted on the test result at time of reporting. Keep out of reach of children and pets. The intended reporting path of the AccuBase A test Kit test resuls include direct reporting to patients and/or a healthcare professional. Test results must be provided to a physician and/ar healthcare professional for interpretation of specific A, values and setting of specific target A . goals.

Source page: https://510kreport.com/device/K013465
Methodology: https://510kreport.com/methodology