FDA product code JBD: System, Analysis, Electrophoretic Hemoglobin
JBD is the FDA product code for system, analysis, electrophoretic hemoglobin. It is a Class II device, regulated under 21 CFR 864.7440 and reviewed by the Hematology panel. FDA has cleared 26 510(k) submissions under JBD, from 9 different applicants. The average 510(k) review took 59 days (median 42). FDA has posted 3 recalls for JBD devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Analysis, Electrophoretic Hemoglobin |
| Device class | Class II |
| Regulation | 21 CFR 864.7440 |
| 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 JBD clearance
Top JBD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 11 | 1999-09-21 |
| Corning Medical & Scientific | 3 | 1983-05-04 |
| Interlab S.R.L. | 2 | 2006-06-30 |
| Gelman Sciences, Inc. | 2 | 1982-04-09 |
| Isolab, Inc. | 2 | 1981-04-23 |
4 more applicants have JBD clearances. See the full list in Caduvo.
Most recent JBD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053571 | Interlab S.R.L. | MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | 2006-06-30 | 190 |
| K032862 | Interlab S.R.L. | INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | 2004-02-03 | 144 |
| K992199 | Helena Laboratories | ACID HEMOGLOBIN KIT | 1999-09-21 | 83 |
| K991362 | Morax | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) | 1999-06-21 | 68 |
| K982426 | Helena Laboratories | SPIFE ALKALINE HEMOGLOBIN | 1998-12-17 | 157 |
Recalls for JBD devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2018-02-27.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code JBD?
JBD is the FDA product code for system, analysis, electrophoretic hemoglobin. It is a Class II device, regulated under 21 CFR 864.7440 and reviewed by the Hematology panel.
What device class is JBD?
Class II, regulation 21 CFR 864.7440. Typical premarket route: 510(k).
How long does a 510(k) take for product code JBD?
Across 26 cleared submissions the average was 59 days from receipt to decision (median 42).
Which companies have the most JBD clearances?
Helena Laboratories (11); Corning Medical & Scientific (3); Interlab S.R.L. (2); Gelman Sciences, Inc. (2); Isolab, Inc. (2).
Have JBD devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2018-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code JBD
- Run a recall and safety report across every JBD manufacturer
- Watch product code JBD 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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