FDA product code JFJ: Catalytic Methods, Amylase
JFJ is the FDA product code for catalytic methods, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel. FDA has cleared 99 510(k) submissions under JFJ, 1 in the last five years, from 62 different applicants. The average 510(k) review took 83 days (median 57). FDA has posted 2 recalls for JFJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Catalytic Methods, Amylase |
| Device class | Class II |
| Regulation | 21 CFR 862.1070 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JFJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 147 |
| 2022 | 1 | 449 |
Compare with all 510(k) review times · Search every JFJ clearance
Top JFJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 7 | 1993-08-19 |
| Abbott Laboratories | 6 | 1998-08-28 |
| Genzyme Corp. | 4 | 2001-08-10 |
| Pointe Scientific, Inc., | 4 | 1993-07-19 |
| Instrumentation Laboratory CO | 3 | 1997-12-17 |
57 more applicants have JFJ clearances. See the full list in Caduvo.
Most recent JFJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210633 | Abbott Ireland Diagnostics Division | Amylase2 | 2022-05-26 | 449 |
| K191454 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Amylase_2 (AMY_2) | 2019-07-30 | 60 |
| K182474 | Biosystems S.A. | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | 2019-05-02 | 234 |
| K130685 | Hitachi Chemical Diagnostics, Inc. | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY | 2013-08-09 | 149 |
| K122858 | Elitechgroup | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II | 2012-10-03 | 15 |
Recalls for JFJ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-07-10.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code JFJ?
JFJ is the FDA product code for catalytic methods, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel.
What device class is JFJ?
Class II, regulation 21 CFR 862.1070. Typical premarket route: 510(k).
How long does a 510(k) take for product code JFJ?
Across 99 cleared submissions the average was 83 days from receipt to decision (median 57).
Which companies have the most JFJ clearances?
Em Diagnostic Systems, Inc. (7); Abbott Laboratories (6); Genzyme Corp. (4); Pointe Scientific, Inc., (4); Instrumentation Laboratory CO (3).
Have JFJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2020-07-10.
Next steps
- Run an FDA pathway report with predicate devices for product code JFJ
- Run a recall and safety report across every JFJ manufacturer
- Watch product code JFJ 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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