FDA product code JIS: Calibrator, Primary
JIS is the FDA product code for calibrator, primary. It is a Class II device, regulated under 21 CFR 862.1150 and reviewed by the Clinical Chemistry panel. FDA has cleared 130 510(k) submissions under JIS, from 63 different applicants. The average 510(k) review took 51 days (median 44). FDA has posted 21 recalls for JIS devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Calibrator, Primary |
| Device class | Class II |
| Regulation | 21 CFR 862.1150 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top JIS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 8 | 1992-09-23 |
| Wako Chemicals USA, Inc. | 7 | 2003-04-11 |
| Dade Behring, Inc. | 6 | 2006-05-31 |
| Beckman Coulter, Inc. | 6 | 2001-05-10 |
| Syva Co. | 6 | 1982-07-16 |
58 more applicants have JIS clearances. See the full list in Caduvo.
Most recent JIS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122126 | Randox Laboratories Limited | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR | 2012-08-14 | 27 |
| K061251 | Dade Behring, Inc. | DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR | 2006-05-31 | 27 |
| K060266 | Dade Behring, Inc. | DIMENSION IRON CALIBRATOR | 2006-03-09 | 36 |
| K053104 | Dade Behring, Inc. | DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR | 2005-12-23 | 49 |
| K032697 | Dade Behring, Inc. | DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) | 2003-11-07 | 66 |
Recalls for JIS devices
21 product recalls in 19 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-04-15.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code JIS?
JIS is the FDA product code for calibrator, primary. It is a Class II device, regulated under 21 CFR 862.1150 and reviewed by the Clinical Chemistry panel.
What device class is JIS?
Class II, regulation 21 CFR 862.1150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JIS?
Across 130 cleared submissions the average was 51 days from receipt to decision (median 44).
Which companies have the most JIS clearances?
E.I. Dupont DE Nemours & Co., Inc. (8); Wako Chemicals USA, Inc. (7); Dade Behring, Inc. (6); Beckman Coulter, Inc. (6); Syva Co. (6).
Have JIS devices been recalled?
Yes: 21 product recalls across 19 recall events; the most recent began 2025-04-15.
Next steps
- Run an FDA pathway report with predicate devices for product code JIS
- Run a recall and safety report across every JIS manufacturer
- Watch product code JIS 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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