LIM · Test, Screening, For D Positive Fetal Rbc'S
Hematology · 21 CFR 864.7455 · Class 2
Overview
| Product Code | LIM |
|---|---|
| Device Name | Test, Screening, For D Positive Fetal Rbc'S |
| Regulation | 21 CFR 864.7455 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A fetal hemoglobin assay is a device that is used to determine the presence and distribution of fetal hemoglobin (hemoglobin F) in red cells or to measure the amount of fetal hemoglobin present. The assay may be used to detect fetal red cells in the maternal circulation or to detect the elevated levels of fetal hemoglobin exhibited in cases of hemoglobin abnormalities such as thalassemia (a hereditary hemolytic anemia characterized by a decreased synthesis of one or more types of hemoglobin polypeptide chains). The hemoglobin determination may be made by methods such as electrophoresis, alkali denaturation, column chromatography, or radial immunodiffusion.
Classification Rationale
Class II (special controls). A fetal hemoglobin stain intended for use with a fetal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A fetal hemoglobin stain intended for use with a fetal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K980314 | FETAL D TECTION KIT | Biopool Intl., Inc. | Apr 8, 1998 | SESE |
| K820647 | GAMMA FETAL BLEED SCREENING TEST | Gamma Biologicals, Inc. | May 12, 1982 | SESE |
Top Applicants
- Gamma Biologicals, Inc. — 1 clearance
- Biopool Intl., Inc. — 1 clearance
