# K172173: DiaSpect Tm, DiaSpect Tm Cuvettes

- Pathway: 510(k) (Traditional)
- Applicant: Ekf-Diagnostic GmbH
- Decided: Apr 6, 2018 after 261 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
Longest line of descent: 1 generation back to K081719 (2008). 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)
- K081719: Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System, Stanbio Laboratory (2008) Summary page 4.

## Indications for use
The DiaSpect Tm system is intended for the in vitro quantitative measurement of total hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in K2EDTA or lithium heparin tubes. The DiaSpect Tm system consists of the DiaSpect Tm analyzer and specifically designed disposable cuvettes, the DiaSpect Tm Cuvettes. The device is intended for use in point-of-care settings. The DiaSpect Tm analyzer is only to be used with DiaSpect Tm Cuvettes.

Source page: https://510kreport.com/device/K172173
Methodology: https://510kreport.com/methodology