FDA product code JCF: Lymphocyte Separation Medium
JCF is the FDA product code for lymphocyte separation medium. It is a Class I device, regulated under 21 CFR 864.8500 and reviewed by the Hematology panel. FDA has cleared 12 510(k) submissions under JCF, from 8 different applicants. The average 510(k) review took 128 days (median 82). FDA has posted 4 recalls for JCF devices.
Classification
| Field | Value |
|---|---|
| Device name | Lymphocyte Separation Medium |
| Device class | Class I |
| Regulation | 21 CFR 864.8500 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JCF clearance
Top JCF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 5 | 1992-12-15 |
| Icn Biomedicals, Inc. | 1 | 1990-08-22 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1988-02-16 |
| Dynal Biotech, Inc. | 1 | 1987-11-04 |
| Sepratech Corporation C/O Keller and Heckman | 1 | 1986-04-18 |
3 more applicants have JCF clearances. See the full list in Caduvo.
Most recent JCF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911731 | Bd Becton Dickinson Vacutainer Systems Preanalytic | LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR | 1992-12-15 | 608 |
| K902445 | Icn Biomedicals, Inc. | LYMPHO SEP(TM) | 1990-08-22 | 82 |
| K891407 | Bd Becton Dickinson Vacutainer Systems Preanalytic | LEUCOPREP CELL SEPARATION TUBE | 1989-05-26 | 73 |
| K874328 | E.I. Dupont DE Nemours & Co., Inc. | L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA | 1988-02-16 | 117 |
| K873185 | Dynal Biotech, Inc. | DYNABEADS HLA CELL PREP II ISOLATION PRODUCT | 1987-11-04 | 84 |
Recalls for JCF devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-07-03.
Frequently asked questions
What is FDA product code JCF?
JCF is the FDA product code for lymphocyte separation medium. It is a Class I device, regulated under 21 CFR 864.8500 and reviewed by the Hematology panel.
What device class is JCF?
Class I, regulation 21 CFR 864.8500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JCF?
Across 12 cleared submissions the average was 128 days from receipt to decision (median 82).
Which companies have the most JCF clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (5); Icn Biomedicals, Inc. (1); E.I. Dupont DE Nemours & Co., Inc. (1); Dynal Biotech, Inc. (1); Sepratech Corporation C/O Keller and Heckman (1).
Have JCF devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2014-07-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JCF
- Run a recall and safety report across every JCF manufacturer
- Watch product code JCF 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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