# K043378: Drew Scientific LTD. Glycated Haemoglobin Two Level Calibrator Kit

- Pathway: 510(k) (Abbreviated)
- Applicant: Drew Scientific, Ltd.
- Decided: Dec 29, 2004 after 21 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For in vitro diagnostic use only. These calibrators are intended for use with instruments for the measurement of HbAl c and are designed to allow calibration to either the American NGSP system or the International IFCC system.

Source page: https://510kreport.com/device/K043378
Methodology: https://510kreport.com/methodology