21 CFR 864.7500 — Acid Hematin
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7500
Identification
A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.
Classification Rationale
Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays 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 |
|---|---|---|---|---|
| GGF | Acid Hematin | 2 | 0 | |
| GGZ | Oxyhemoglobin | 2 | 2 | 3rd Party |
| GIG | Hemoglobinometer | 2 | 3 | 3rd Party |
| GJZ | Cyanomethemoglobin Reagent And Standard Solution | 2 | 2 | 3rd Party |
| GKK | Cyanomethemoglobin | 2 | 7 | 3rd Party |
| GLY | Oximeter To Measure Hemoglobin | 2 | 5 | 3rd Party |
| KHG | Whole Blood Hemoglobin Determination | 2 | 39 | 3rd Party |
| LGL | Assay, Bart'S, Hemoglobin | 2 | 2 | 3rd Party |
| QGU | Hemoglobin For Donor Testing | 2 | 0 |
Special Controls
GGF — Acid Hematin
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GGZ — Oxyhemoglobin
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GIG — Hemoglobinometer
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GJZ — Cyanomethemoglobin Reagent And Standard Solution
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GKK — Cyanomethemoglobin
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
GLY — Oximeter To Measure Hemoglobin
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
KHG — Whole Blood Hemoglobin Determination
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
LGL — Assay, Bart'S, Hemoglobin
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
QGU — Hemoglobin For Donor Testing
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
