# K140827: SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Sd Biosensor, Inc.
- Decided: Sep 30, 2015 after 547 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: 3 generations back to K033847 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090413: A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional Use) Model 3021, A1CNOW Self Chec, Bayer Healthcare, LLC (2009) Summary page 4.
- K110056: Afinion Analyzer, Axis-Shield Poc AS (2011) Summary page 4.

## Indications for use
The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (%HbA1c) levels in fresh fingerstick capillary blood or venous whole blood samples. This system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes. The SD A1cCare Spoit Type Test Kit is part of the SD A1cCare System. It includes the test panel that receives the blood sample and is used with the SD A1cCare Analyzer for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh fingerstick capillary or venous whole blood samples. The system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control in persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes. The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level M are intended for use as quality control materials for the SD A1cCare System.

Source page: https://510kreport.com/device/K140827
Methodology: https://510kreport.com/methodology