FDA product code JIX: Calibrator, Multi-Analyte Mixture
JIX is the FDA product code for calibrator, multi-analyte mixture. It is a Class II device, regulated under 21 CFR 862.1150 and reviewed by the Clinical Chemistry panel. FDA has cleared 302 510(k) submissions under JIX, from 106 different applicants. The average 510(k) review took 66 days (median 48). FDA has posted 73 recalls for JIX devices, 12 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Calibrator, Multi-Analyte Mixture |
| Device class | Class II |
| Regulation | 21 CFR 862.1150 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JIX clearance
Top JIX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alko Diagnostic Corp. | 21 | 2000-06-19 |
| Dade Behring, Inc. | 18 | 2007-10-17 |
| Bhp Diagnostix, Inc. | 11 | 1986-08-19 |
| Roche Diagnostics Corp. | 10 | 2008-05-12 |
| Roche Diagnostic Systems, Inc. | 9 | 1995-09-20 |
101 more applicants have JIX clearances. See the full list in Caduvo.
Most recent JIX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161140 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products Calibrator Kit 3 | 2016-05-20 | 28 |
| K153365 | Siemens Healthcare Diagnostics, Inc. | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | 2015-12-18 | 28 |
| K151552 | Elitechgroup | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | 2015-07-08 | 29 |
| K140790 | Siemens Healthcare Diagnostics | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) | 2015-06-15 | 441 |
| K141388 | Beckman Coulter Ireland, Inc. | SYSTEM CALIBRATER | 2014-07-11 | 45 |
Recalls for JIX devices
73 product recalls in 58 recall events; 12 initiated in the last five years and 13 still open. Most recent: 2026-07-01.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 3 |
| 2019 | 8 |
| 2020 | 2 |
| 2021 | 2 |
| 2023 | 8 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code JIX?
JIX is the FDA product code for calibrator, multi-analyte mixture. It is a Class II device, regulated under 21 CFR 862.1150 and reviewed by the Clinical Chemistry panel.
What device class is JIX?
Class II, regulation 21 CFR 862.1150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JIX?
Across 302 cleared submissions the average was 66 days from receipt to decision (median 48).
Which companies have the most JIX clearances?
Alko Diagnostic Corp. (21); Dade Behring, Inc. (18); Bhp Diagnostix, Inc. (11); Roche Diagnostics Corp. (10); Roche Diagnostic Systems, Inc. (9).
Have JIX devices been recalled?
Yes: 73 product recalls across 58 recall events; the most recent began 2026-07-01.
Next steps
- Run an FDA pathway report with predicate devices for product code JIX
- Run a recall and safety report across every JIX manufacturer
- Watch product code JIX 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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