# K060510: Drew Scientific Glycated Hemoglobin Five Level Linearity Kit

- Pathway: 510(k) (Traditional)
- Applicant: Drew Scientific, Ltd.
- Decided: Jun 19, 2006 after 112 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
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. The Drew Scientific Glycated Hemoglobin Five Level Linearity Kit is intended to verify the linearity of HbAl c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.

Source page: https://510kreport.com/device/K060510
Methodology: https://510kreport.com/methodology