# K142664: URight Hemoglobin A1c system, FORA A1c System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jan 29, 2016 after 498 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 K951361 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071466: Dca Vantage, Model 5075, Siemens Medical Solutions Diagnostics (2007) Summary page 6.
- K031539: Hemoglobin A1C Reagent Set, Pointe Scientific, Inc., (2003) Summary page 6.

## Indications for use
The URight Hemoglobin A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use. The URight Hemoglobin A1c Control Solution is intended for use as quality control material for the URight Hemoglobin A1c System. The FORA A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use. The FORA A1c Control Solution is intended for use as quality control material for the FORA A1c System.

Source page: https://510kreport.com/device/K142664
Methodology: https://510kreport.com/methodology