FDA product code JFY: Enzymatic Method, Creatinine
JFY is the FDA product code for enzymatic method, creatinine. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Chemistry panel. FDA has cleared 49 510(k) submissions under JFY, 1 in the last five years, from 37 different applicants. The average 510(k) review took 134 days (median 117); 185 days on average over the last three years. FDA has posted 29 recalls for JFY devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzymatic Method, Creatinine |
| Device class | Class II |
| Regulation | 21 CFR 862.1225 |
| 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 JFY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 414 |
| 2018 | 2 | 112 |
| 2019 | 2 | 194 |
| 2021 | 2 | 314 |
| 2026 | 1 | 185 |
Compare with all 510(k) review times · Search every JFY clearance
Top JFY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | 5 | 2018-10-30 |
| Boehringer Mannheim Corp. | 4 | 1991-08-12 |
| Siemens Healthcare Diagnostics, Inc. | 2 | 2021-11-24 |
| HORIBA ABX SAS | 2 | 2021-05-10 |
| Teco Diagnostics, Inc. | 2 | 2017-07-21 |
32 more applicants have JFY clearances. See the full list in Caduvo.
Most recent JFY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252619 | Qstag, Inc. | QSCHECK UISACR | 2026-02-20 | 185 |
| K212223 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Enzymatic Creatinine_3 (ECre3) | 2021-11-24 | 131 |
| K193649 | HORIBA ABX SAS | Yumizen C1200 Creatinine PAP | 2021-05-10 | 497 |
| K182384 | Healthy.Io, Ltd. | ACR LAB Urine Analysis Test System | 2019-07-26 | 329 |
| K183555 | Instrumentation Laboratory CO | GEM Premier ChemSTAT | 2019-02-16 | 58 |
Recalls for JFY devices
29 product recalls in 20 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-07-13.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 5 |
| 2020 | 5 |
Frequently asked questions
What is FDA product code JFY?
JFY is the FDA product code for enzymatic method, creatinine. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Chemistry panel.
What device class is JFY?
Class II, regulation 21 CFR 862.1225. Typical premarket route: 510(k).
How long does a 510(k) take for product code JFY?
Across 49 cleared submissions the average was 134 days from receipt to decision (median 117).
Which companies have the most JFY clearances?
Ortho-Clinical Diagnostics, Inc. (5); Boehringer Mannheim Corp. (4); Siemens Healthcare Diagnostics, Inc. (2); HORIBA ABX SAS (2); Teco Diagnostics, Inc. (2).
Have JFY devices been recalled?
Yes: 29 product recalls across 20 recall events; the most recent began 2020-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code JFY
- Run a recall and safety report across every JFY manufacturer
- Watch product code JFY 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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