# K981427: Stat Profile M Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: May 12, 1998 after 26 days
- Product code: GKF (Instrument, Hematocrit, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5600
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Sep 22, 2003 · Not classified · Z-0060-04: Degradation of the magnesium sensor could result in low ionozed magnesium patient samples

## Indications for use
The Stat Profile Ultra M Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of sodium, potassium, chloride, ionized calcium, ionized magnesium, glucose, urea nitrogen, lactate, pH, PCO2, P02, oxygen saturation, lactate, hemoglobin and hematocrit in serum, plasma and whole blood. intended for Point-of-Care Usage

Source page: https://510kreport.com/device/K981427
Methodology: https://510kreport.com/methodology