FDA product code CIJ: Saccharogenic, Amylase
CIJ is the FDA product code for saccharogenic, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel. FDA has cleared 31 510(k) submissions under CIJ, from 22 different applicants. The average 510(k) review took 84 days (median 62). FDA has posted 1 recall for CIJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Saccharogenic, 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 |
Compare with all 510(k) review times · Search every CIJ clearance
Top CIJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Harleco | 4 | 1981-10-02 |
| Pointe Scientific, Inc., | 2 | 2002-12-23 |
| Data Medical Associates, Inc. | 2 | 1994-03-11 |
| Biotrol, USA, Inc. | 2 | 1993-05-26 |
| Behring Diagnostics, Inc. | 2 | 1987-06-03 |
17 more applicants have CIJ clearances. See the full list in Caduvo.
Most recent CIJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023396 | Pointe Scientific, Inc., | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | 2002-12-23 | 75 |
| K991817 | Bayer Corp. | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | 1999-07-22 | 56 |
| K980013 | Ac Biochemicals, Inc. | AMYLASE | 1998-02-04 | 33 |
| K953211 | Randox Laboratories, Ltd. | AMYLASE (ETHYLIDENE PNGPG7) KIT | 1996-06-21 | 347 |
| K951494 | Emd Chemicals, Inc. | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | 1995-12-11 | 255 |
Recalls for CIJ devices
1 product recalls in 1 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 CIJ?
CIJ is the FDA product code for saccharogenic, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel.
What device class is CIJ?
Class II, regulation 21 CFR 862.1070. Typical premarket route: 510(k).
How long does a 510(k) take for product code CIJ?
Across 31 cleared submissions the average was 84 days from receipt to decision (median 62).
Which companies have the most CIJ clearances?
Harleco (4); Pointe Scientific, Inc., (2); Data Medical Associates, Inc. (2); Biotrol, USA, Inc. (2); Behring Diagnostics, Inc. (2).
Have CIJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-07-10.
Next steps
- Run an FDA pathway report with predicate devices for product code CIJ
- Run a recall and safety report across every CIJ manufacturer
- Watch product code CIJ 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