FDA product code JPD: Hemoglobin A2 Quantitation
JPD is the FDA product code for hemoglobin a2 quantitation. It is a Class II device, regulated under 21 CFR 864.7400 and reviewed by the Hematology panel. FDA has cleared 13 510(k) submissions under JPD, from 5 different applicants. The average 510(k) review took 75 days (median 69). FDA has posted 5 recalls for JPD devices.
Classification
| Field | Value |
|---|---|
| Device name | Hemoglobin A2 Quantitation |
| Device class | Class II |
| Regulation | 21 CFR 864.7400 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top JPD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 6 | 1992-08-25 |
| Bio-Rad | 4 | 1999-06-10 |
| Tosoh Medics, Inc. | 1 | 2002-05-14 |
| Drew Scientific , Ltd. | 1 | 1992-11-16 |
| Isolab, Inc. | 1 | 1980-07-21 |
Most recent JPD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020489 | Tosoh Medics, Inc. | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | 2002-05-14 | 90 |
| K991127 | Bio-Rad | VARIANT II B-THALASSEMIA | 1999-06-10 | 69 |
| K924122 | Bio-Rad | VARIANT BETA-THALASSEMIA SHORT PROGRAM | 1993-03-11 | 209 |
| K924496 | Drew Scientific , Ltd. | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT | 1992-11-16 | 73 |
| K923317 | Helena Laboratories | COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL | 1992-08-25 | 49 |
Recalls for JPD devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-04-08.
Frequently asked questions
What is FDA product code JPD?
JPD is the FDA product code for hemoglobin a2 quantitation. It is a Class II device, regulated under 21 CFR 864.7400 and reviewed by the Hematology panel.
What device class is JPD?
Class II, regulation 21 CFR 864.7400. Typical premarket route: 510(k).
How long does a 510(k) take for product code JPD?
Across 13 cleared submissions the average was 75 days from receipt to decision (median 69).
Which companies have the most JPD clearances?
Helena Laboratories (6); Bio-Rad (4); Tosoh Medics, Inc. (1); Drew Scientific , Ltd. (1); Isolab, Inc. (1).
Have JPD devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2014-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code JPD
- Run a recall and safety report across every JPD manufacturer
- Watch product code JPD 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.