FDA product code JCM: Control, Hemoglobin, Abnormal
JCM is the FDA product code for control, hemoglobin, abnormal. It is a Class II device, regulated under 21 CFR 864.7415 and reviewed by the Hematology panel. FDA has cleared 12 510(k) submissions under JCM, from 8 different applicants. The average 510(k) review took 115 days (median 68). FDA has posted 1 recall for JCM devices.
Classification
| Field | Value |
|---|---|
| Device name | Control, Hemoglobin, Abnormal |
| Device class | Class II |
| Regulation | 21 CFR 864.7415 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Top JCM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Isolab, Inc. | 4 | 1995-01-20 |
| Helena Laboratories | 2 | 1994-10-31 |
| Cantebury Scientific , Ltd. | 1 | 2005-12-07 |
| Canterbury Health Laboratories | 1 | 2001-06-21 |
| Roche Diagnostic Systems, Inc. | 1 | 1999-02-10 |
3 more applicants have JCM clearances. See the full list in Caduvo.
Most recent JCM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053031 | Cantebury Scientific , Ltd. | EXTENDSURE HBFASC CONTROL | 2005-12-07 | 41 |
| K011389 | Canterbury Health Laboratories | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) | 2001-06-21 | 45 |
| K983704 | Roche Diagnostic Systems, Inc. | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | 1999-02-10 | 112 |
| K942222 | Isolab, Inc. | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | 1995-01-20 | 259 |
| K933086 | Helena Laboratories | AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 | 1994-10-31 | 495 |
Recalls for JCM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-11-07.
Frequently asked questions
What is FDA product code JCM?
JCM is the FDA product code for control, hemoglobin, abnormal. It is a Class II device, regulated under 21 CFR 864.7415 and reviewed by the Hematology panel.
What device class is JCM?
Class II, regulation 21 CFR 864.7415. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JCM?
Across 12 cleared submissions the average was 115 days from receipt to decision (median 68).
Which companies have the most JCM clearances?
Isolab, Inc. (4); Helena Laboratories (2); Cantebury Scientific , Ltd. (1); Canterbury Health Laboratories (1); Roche Diagnostic Systems, Inc. (1).
Have JCM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-11-07.
Next steps
- Run an FDA pathway report with predicate devices for product code JCM
- Run a recall and safety report across every JCM manufacturer
- Watch product code JCM 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.