# K023561: Itc HGB Pro Professional Hemoglobin Testing System

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: Jan 31, 2003 after 100 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- 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. The FDA summary names its predicate without a number.
- (no number) Coulter MD8: named in the summary without a submission number

## Indications for use
The Hgb Pro Professional Hemoglobin Testing SystemTM consists of a portable, battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary or venous (EDTA) whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility. The Hgb Pro Professional Hemoglobin Testing System is not intended for home use.

Source page: https://510kreport.com/device/K023561
Methodology: https://510kreport.com/methodology