21 CFR 864.7455 — Hemoglobin, Alkali Resistant
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7455
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GHA | Hemoglobin, Alkali Resistant | 2 | 0 | 3rd Party |
| GHQ | Stain, Fetal Hemoglobin | 2 | 2 | |
| JPC | Hemoglobin F Quantitation | 2 | 1 | 3rd Party |
| KQI | Assay, Fetal Hemoglobin | 2 | 4 | 3rd Party |
| LIM | Test, Screening, For D Positive Fetal Rbc'S | 2 | 2 |
Special Controls
GHA — Hemoglobin, Alkali Resistant
*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.
eCFR
GHQ — Stain, Fetal Hemoglobin
*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.
eCFR
JPC — Hemoglobin F Quantitation
*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.
eCFR
KQI — Assay, Fetal Hemoglobin
*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.
eCFR
LIM — Test, Screening, For D Positive Fetal Rbc'S
*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.
eCFR
