FDA product code KQI: Assay, Fetal Hemoglobin
KQI is the FDA product code for assay, fetal hemoglobin. It is a Class II device, regulated under 21 CFR 864.7455 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under KQI, from 2 different applicants. The average 510(k) review took 36 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Assay, Fetal Hemoglobin |
| Device class | Class II |
| Regulation | 21 CFR 864.7455 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KQI clearance
Top KQI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 3 | 1988-04-21 |
| Isolab, Inc. | 1 | 1979-07-17 |
Most recent KQI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880653 | Helena Laboratories | HBF DILUENT | 1988-04-21 | 64 |
| K812226 | Helena Laboratories | HELENA HBF QUIPLATE CONTROL | 1981-09-01 | 22 |
| K810475 | Helena Laboratories | HELENA HEMOGLOBIN F CONTROLS | 1981-03-26 | 31 |
| K791143 | Isolab, Inc. | SICKLE-CELL F TEST | 1979-07-17 | 29 |
Recalls for KQI devices
openFDA lists no recalls for product code KQI.
Frequently asked questions
What is FDA product code KQI?
KQI is the FDA product code for assay, fetal hemoglobin. It is a Class II device, regulated under 21 CFR 864.7455 and reviewed by the Hematology panel.
What device class is KQI?
Class II, regulation 21 CFR 864.7455. Typical premarket route: 510(k).
How long does a 510(k) take for product code KQI?
Across 4 cleared submissions the average was 36 days from receipt to decision (median 30).
Which companies have the most KQI clearances?
Helena Laboratories (3); Isolab, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KQI
- Run a recall and safety report across every KQI manufacturer
- Watch product code KQI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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