# K183230: OneDraw A1C Test System

- Pathway: 510(k) (Traditional)
- Applicant: Drawbridge Health, Inc.
- Decided: Aug 15, 2019 after 268 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: 5 generations back to K861697 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141944: Home Access Aic Test, Home Access Health Corp. (2015) Summary page 4.

## Indications for use
The OneDraw™ A1C Test System, which consists of the OneDraw Blood Collection Device and the OneDraw A1C Test, is intended to collect capillary blood from the upper arm of individuals 18 years of age or older onto filter (matrix) paper within the collection device by a healthcare professional. Samples are delivered to the laboratory for the quantitative measurement of HbA1c for monitoring the long-term control of blood sugar (glucose) in people with diabetes. Testing performed on samples collected with this device should not be used to diagnose or screen for diabetes. The OneDraw A1C Test System should not be used with neonates.

Source page: https://510kreport.com/device/K183230
Methodology: https://510kreport.com/methodology