# K983172: Accu-Base Hemoglobin A1C Sample Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diabetes Technologies, Inc. (Dti)
- Decided: Nov 30, 1998 after 81 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
Longest line of descent: 2 generations back to K861697 (1986). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973365: Aic - Chek (Hbaic-I), Express-Med, Inc. (1998) Summary page 1.
- K971919: Ezchek/Hba Blood Collection Kit, Flexsite Diagnostics, Inc. (1997) Summary page 1.
- K861697: Self Assure/GHB (Capillary-Blood Collection Kit), Awareness Technology, Inc. (1986) Summary page 1.
- K851636: Diamat Glycoslated Hemoglobin Analyzer System, Bio-Rad (1985) Summary page 1.

## Most influential descendants
- 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
The intended use of the Accu-Base Hemoglobin Aic Sample Collection Kit is for the determination of the relative percent (%) hemoglobin Aic in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC) as the analytical method. The Accu-Base Hemoglobin Aic Sample Collection Kit will be available to patients through Point of Care Offices and/or Centers, for the purpose of monitoring individual, long-term diabetes control as part of a comprehensive diabetes management & treatment program. The Accu-Base Hemoglobin Aic Sample Collection Kit does not replace daily blood glucose monitoring. There are no known contraindications. Keep out of reach of children. The intended reporting path of the HbAic test results include direct reporting to the physician/health care professional responsible for the care of the individual for clinical interpretation including setting and interpreting specific HbAic target goals and test results. In addition the results may be reported to the patient.

Source page: https://510kreport.com/device/K983172
Methodology: https://510kreport.com/methodology