# K990641: Caltag Fetal Hemoglobin Test

- Pathway: 510(k) (Traditional)
- Applicant: Caltag Laboratories, Inc.
- Decided: Sep 17, 1999 after 203 days
- Product code: GHQ (Stain, Fetal Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7455
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K892241 (1989). 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)
- K892241: Fetal Hemoglobin, Sure-Tech Diagnostic Associates, Inc. (1989) Summary page 1.

## Recalls of this device
- Feb 7, 2018 · Class II · Z-1388-2018: Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.

## Indications for use
The Caltag Fetal Hemoglobin Test, containing either FITC, R-PE or TRI-COLOR® conjugated monoclonal antibodies to fetal hemoglobin (hemoglobin F), is intended for the identification followed by enumeration of fetal red blood cells. Fetal red cells are identified by the presence of fetal hemoglobin by a flow cytometric method. Fetal cells, when found in the maternal circulation, may be an indication of fetal or maternal trauma or various obstetrical complications. The hemorrhage of Rh+ fetal blood into Rh- maternal blood may result in the formation of sensitizing Rh antibodies in the mother. Sensitization may be prevented by the administration to the mother of Rh immune globulin (RhIg) soon after delivery. The Caltag Fetal Hemoglobin Test may be used as an aid in detecting Rh incompatible fetal-maternal hemorrhage and determining the need for immunoprophylaxis with Rh immune globulin.

Source page: https://510kreport.com/device/K990641
Methodology: https://510kreport.com/methodology