FDA product code JIF: Enzymatic Method, Ammonia
JIF is the FDA product code for enzymatic method, ammonia. It is a Class I device, regulated under 21 CFR 862.1065 and reviewed by the Clinical Chemistry panel. FDA has cleared 30 510(k) submissions under JIF, from 23 different applicants. The average 510(k) review took 71 days (median 48). FDA has posted 11 recalls for JIF devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzymatic Method, Ammonia |
| Device class | Class I |
| Regulation | 21 CFR 862.1065 |
| 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 JIF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 52 |
Compare with all 510(k) review times · Search every JIF clearance
Top JIF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 3 | 1998-07-22 |
| Siemens Healthcare Diagnostics | 2 | 2013-03-07 |
| Diagnostic Chemicals , Ltd. | 2 | 2004-03-10 |
| Bayer Diagnostics Corp. | 2 | 2002-12-24 |
| Beckman Coulter, Inc. | 2 | 2000-12-22 |
18 more applicants have JIF clearances. See the full list in Caduvo.
Most recent JIF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183517 | Roche Diagnostics Operations (Rdo) | Ammonia II | 2019-02-08 | 52 |
| K123677 | Siemens Healthcare Diagnostics | DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) | 2013-03-07 | 97 |
| K123320 | Siemens Healthcare Diagnostics | DIMENSION AMMONIA FLEX REAGENT CARTRIDGE | 2013-02-15 | 112 |
| K062316 | Dade Behring, Inc. | DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE | 2006-09-06 | 28 |
| K051114 | Sentinel Ch. Srl | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY | 2005-11-25 | 207 |
Recalls for JIF devices
11 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-07-30.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2020 | 2 |
Frequently asked questions
What is FDA product code JIF?
JIF is the FDA product code for enzymatic method, ammonia. It is a Class I device, regulated under 21 CFR 862.1065 and reviewed by the Clinical Chemistry panel.
What device class is JIF?
Class I, regulation 21 CFR 862.1065. Typical premarket route: 510(k).
How long does a 510(k) take for product code JIF?
Across 30 cleared submissions the average was 71 days from receipt to decision (median 48).
Which companies have the most JIF clearances?
Abbott Laboratories (3); Siemens Healthcare Diagnostics (2); Diagnostic Chemicals , Ltd. (2); Bayer Diagnostics Corp. (2); Beckman Coulter, Inc. (2).
Have JIF devices been recalled?
Yes: 11 product recalls across 7 recall events; the most recent began 2020-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code JIF
- Run a recall and safety report across every JIF manufacturer
- Watch product code JIF 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times