Product code JJX: 510(k) clearances and predicates
Product code JJX covers Beta-CrossLaps CalCheck 5. FDA lists 493 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
493 clearances on file under product code JJX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest JJX clearances in the FDA index, with applicant and decision date:
- K170678, Beta-CrossLaps CalCheck 5, applicant Roche Diagnostics, decided 2017-04-04. FDA record
- K162173, Elecsys CYFRA 21-1 CalCheck 5, applicant Roche Diagnostics, decided 2017-01-12. FDA record
- K162514, Multichem A1c, applicant Technopath Manufacturing, decided 2016-10-26. FDA record
- K161874, Audit MicroControls Linearity DROP LQ Blood Glucose, applicant Aalto Scientific, Ltd., decided 2016-08-10. FDA record
- K161526, LIAISON CMV IgM Serum Control Set, applicant DiaSorin, Inc., decided 2016-06-30. FDA record
- K161522, LIAISON EBV IgM Serum Control Set, applicant DiaSorin, Inc., decided 2016-06-30. FDA record
- K161082, IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers, applicant Immunodiagnostic Systems , Ltd., decided 2016-05-17. FDA record
- K152117, Dropper hsCRP High Sensitivity CRP Control, applicant Quantimetrix Corporation, decided 2016-04-21. 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 Elecsys CYFRA 21-1 CalCheck 5, Multichem A1c. Watch new JJX 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 JJX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JJX clearances include Beta-CrossLaps CalCheck 5.
How many 510(k) clearances use product code JJX?
493 at the time this page was generated, from openFDA records.
How do I find a predicate device under JJX?
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 JJX clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.