Product code JIT: 510(k) clearances and predicates
Product code JIT covers VITROS Immunodiagnostic Products Insulin Calibrators. FDA lists 245 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
245 clearances on file under product code JIT. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest JIT clearances in the FDA index, with applicant and decision date:
- K171168, VITROS Immunodiagnostic Products Insulin Calibrators, applicant Ortho Clinical Diagnostics, decided 2017-05-16. FDA record
- K170938, CalSet IGF-1, applicant Roche Diagnostics, decided 2017-04-26. FDA record
- K170160, Abbott ARCHITECT Free T3, applicant Abbott Laboratories, decided 2017-02-15. FDA record
- K163534, Lumipulse G FSH-N Calibrators, applicant Fujirebio Diagnostics,Inc., decided 2017-01-13. FDA record
- K163546, Lumipulse G Progesterone-N Calibrators, applicant Fujirebio Diagnostics,Inc., decided 2017-01-13. FDA record
- K163544, Lumipulse G Prolactin, applicant Fujirebio Diagnostics,Inc., decided 2017-01-12. FDA record
- K163521, Lumipulse G LH Calibrators, applicant Fujirebio Diagnostics,Inc., decided 2017-01-12. FDA record
- K163078, DC-UIBC-CAL, applicant Sekisui Diagnostics P.E.I., Inc., decided 2016-12-08. 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 CalSet IGF-1, Abbott ARCHITECT Free T3. Watch new JIT 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 JIT?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JIT clearances include VITROS Immunodiagnostic Products Insulin Calibrators.
How many 510(k) clearances use product code JIT?
245 at the time this page was generated, from openFDA records.
How do I find a predicate device under JIT?
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 JIT clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.