Caltag Fetal Hemoglobin Test

• • Terminated Z-1388-2018 FDA Class II ·initiated 7 Feb 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.e. false positives)

510(k) Number

K990641 ↗

FDA Product Code

GHQ

Device Class

Class II

Regulation

21 CFR Part 864.7455

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• CD3 Fitc/CD4 R-Pe Monoclonal Antibody Combination

  Class II

  FDA 510(k) K950918 Active Cleared 21 Dec 1995

• CD3 Fitc/CD19 R-Pe/CD45 Tri-Color Monoclonal Antibody Combination

  Class II

  FDA 510(k) K964856 Active Cleared 17 Jan 1997

• CD3 Fitc/CD4 R-Pe/CD45 Tri-Color Monoclonal Antibody Combination

  Class II

  FDA 510(k) K950919 Active Cleared 20 Dec 1995

• CD3 Fitc/CD8 R-Pe Monoclonal Antibody Combination

  Class II

  FDA 510(k) K950916 Active Cleared 21 Dec 1995

• Caltag CD8 Fitc and CD8 R-Pe Monoclonal Antibodies

  Class II

  FDA 510(k) K944126 Active Cleared 20 Jun 1995

• Caltag CD3 Fitc, R-Pe, Tri-Color Monoclonal Antibody

  Class II

  FDA 510(k) K944127 Active Cleared 20 Jun 1995

See all devices from Caltag Laboratories, Inc. →

• What is the Caltag Fetal Hemoglobin Test used for?

  This test identifies and quantifies fetal red blood cells in maternal circulation by detecting fetal hemoglobin (HbF) expression. It helps clinicians assess the risk of fetal-maternal hemorrhage during pregnancy, which can impact maternal and fetal health.

• How is the Caltag Fetal Hemoglobin Test supplied and used?

  The test is supplied as a reagent kit designed for single-use in laboratory settings. It requires flow cytometric analysis, where monoclonal antibodies conjugated with fluorescent dyes (FITC, R-PE, or TRI-COLOR®) bind to fetal hemoglobin on red blood cells. Known control values are used to set detection thresholds for accurate fetal cell enumeration.

• Is the Caltag Fetal Hemoglobin Test sterile and reusable?

  The test is intended for single-use per manufacturer specifications. While the reagent kit itself is not explicitly described as sterile, standard in vitro diagnostic reagent protocols must be followed for storage and handling to ensure reliability and safety.

• What regulatory approval does the Caltag Fetal Hemoglobin Test hold?

  The device holds FDA 510(k) clearance under the reference number K990641, classified as a Class II medical device under regulation number 864.7455. This clearance confirms it is substantially equivalent to a predicate device and meets regulatory standards for safety and effectiveness.

• What storage conditions should be followed for the Caltag Fetal Hemoglobin Test?

  While specific storage conditions are not detailed, the test must adhere to standard in vitro diagnostic reagent protocols to maintain integrity. This typically includes protection from light, extreme temperatures, and contamination, ensuring optimal performance for flow cytometric analysis.