# K982022: Vigil Hemoglobin (Hbalc) Controls

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 6, 1998 after 27 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934070 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934070: Tina-Quant Hemoglobin A1C, Boehringer Mannheim Corp. (1994) Summary page 1.
- (no number) Precinorm® HbA1c: named in the summary without a submission number
- (no number) Precipath® HbA1c: named in the summary without a submission number

## Indications for use
The Beckman Vigil Hemoglobin A1c (HbA1c) Controls are designed for monitoring the reliability and overall performance of Beckman Hemoglobin A1c (HbA1c) test systems in the clinical laboratory. The use of two levels of control allows the laboratorian to monitor analytical error and imprecision.

Source page: https://510kreport.com/device/K982022
Methodology: https://510kreport.com/methodology