Product code JIX: 510(k) clearances and predicates
Product code JIX covers VITROS Chemistry Products Calibrator Kit 3. FDA lists 302 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
302 clearances on file under product code JIX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest JIX clearances in the FDA index, with applicant and decision date:
- K161140, VITROS Chemistry Products Calibrator Kit 3, applicant Ortho-Clinical Diagnostics, Inc., decided 2016-05-20. FDA record
- K153365, ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator, applicant Siemens Healthcare Diagnostics, Inc., decided 2015-12-18. FDA record
- K151552, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II, applicant Elitechgroup, decided 2015-07-08. FDA record
- K140790, Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG), applicant Siemens Healthcare Diagnostics, decided 2015-06-15. FDA record
- K141388, SYSTEM CALIBRATER, applicant Beckman Coulter Ireland, Inc., decided 2014-07-11. FDA record
- K133330, C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN, applicant Roche Diagnostics, decided 2013-11-26. FDA record
- K130765, ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II, applicant Elitechgroup, decided 2013-04-04. FDA record
- K123321, DIMENSION CHEMISTRY III CALIBRATORY, applicant Siemens Healthcare Diagnostics, decided 2013-02-15. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II. Watch new JIX clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JIX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JIX clearances include VITROS Chemistry Products Calibrator Kit 3.
How many 510(k) clearances use product code JIX?
302 at the time this page was generated, from openFDA records.
How do I find a predicate device under JIX?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JIX clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.