# K163633: cobas HbA1c Test, cobas b 101 system

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations
- Decided: Jul 28, 2017 after 218 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 7.

## Indications for use
cobas b 101 system: The cobas b 101 instrument is a multi-assay system designed to quantitatively analyze cobas reagent discs. The system is intended for professional, in vitro diagnostic use in a clinical laboratory setting or point-of-care (PoC) locations. HbA1c test: The cobas HbA1c Test is an in vitro diagnostic test designed to quantitatively determine glycated hemoglobin (HbA 1¢) in human capillary and venous whole blood on the cobas b 101 instrument. The system is intended for professional use in a clinical laboratory setting or point-of-care (PoC) locations. Measurement of hemoglobin Alc is used to assess the level of control of a patient's diabetes and to monitor long term blood glucose control. Elevated levels of hemoglobin Alc indicate uncontrolled diabetes in a patient.

Source page: https://510kreport.com/device/K163633
Methodology: https://510kreport.com/methodology