FDA product code CJE: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
CJE is the FDA product code for nitrophenylphosphate, alkaline phosphatase or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel. FDA has cleared 124 510(k) submissions under CJE, 3 in the last five years, from 88 different applicants. The average 510(k) review took 62 days (median 44); 247 days on average over the last three years. FDA has posted 22 recalls for CJE devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1050 |
| 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 CJE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 140 |
| 2018 | 1 | 209 |
| 2019 | 1 | 113 |
| 2023 | 1 | 266 |
| 2024 | 1 | 239 |
| 2025 | 1 | 255 |
Compare with all 510(k) review times · Search every CJE clearance
Top CJE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 10 | 1993-12-09 |
| Abbott Laboratories | 5 | 2002-12-26 |
| Harleco | 5 | 1981-09-29 |
| Sigma Diagnostics, Inc. | 4 | 1996-02-28 |
| J.T. Baker Chemical Co. | 4 | 1977-08-04 |
83 more applicants have CJE clearances. See the full list in Caduvo.
Most recent CJE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251074 | Truvian Health | Tru Liver Health Test Panel | 2025-12-19 | 255 |
| K240468 | Abbott Laboratories Diagnostics Division | Alkaline Phosphatase | 2024-10-16 | 239 |
| K223317 | Abbott Ireland Diagnostics Division | Alkaline Phosphatase2 | 2023-07-21 | 266 |
| K191245 | HORIBA ABX SAS | Yumizen C1200 ALP, Yumizen C1200 Albumin | 2019-08-30 | 113 |
| K171971 | Lite-On Technology Corp. H.S.P.B. | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer | 2018-01-25 | 209 |
Recalls for CJE devices
22 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code CJE?
CJE is the FDA product code for nitrophenylphosphate, alkaline phosphatase or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel.
What device class is CJE?
Class II, regulation 21 CFR 862.1050. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJE?
Across 124 cleared submissions the average was 62 days from receipt to decision (median 44).
Which companies have the most CJE clearances?
Em Diagnostic Systems, Inc. (10); Abbott Laboratories (5); Harleco (5); Sigma Diagnostics, Inc. (4); J.T. Baker Chemical Co. (4).
Have CJE devices been recalled?
Yes: 22 product recalls across 6 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code CJE
- Run a recall and safety report across every CJE manufacturer
- Watch product code CJE 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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