Product code JLW: 510(k) clearances and predicates
Product code JLW covers Atellica® IM TSH3-Ultra II (TSH3ULII). FDA lists 242 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
242 clearances on file under product code JLW. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 so far | 1 |
Recent clearances
Newest JLW clearances in the FDA index, with applicant and decision date:
- K251543, Atellica® IM TSH3-Ultra II (TSH3ULII), applicant Siemens Healthcare Diagnostics, Inc., decided 2026-02-06. FDA record
- K243570, Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L), applicant Siemens Healthcare Diagnostics, decided 2025-04-25. FDA record
- K234091, Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0, applicant Genalyte, Inc., decided 2024-07-22. FDA record
- K233050, ADVIA Centaur® TSH3-Ultra II (TSH3ULII), applicant Siemens Healthcare Diagnostics, Inc., decided 2024-04-04. FDA record
- K222116, Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP), applicant Siemens Healthcare Diagnostics, Inc., decided 2023-07-13. FDA record
- K221225, Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer, applicant Beckman Coulter, Inc., decided 2022-11-10. FDA record
- K190773, Elecsys TSH, applicant Roche Diagnostics, decided 2019-04-16. FDA record
- K170232, AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer, applicant Boditech Med, Inc., decided 2017-10-13. 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 Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L), Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0. Watch new JLW 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 JLW?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JLW clearances include Atellica® IM TSH3-Ultra II (TSH3ULII).
How many 510(k) clearances use product code JLW?
242 at the time this page was generated, from openFDA records.
How do I find a predicate device under JLW?
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 JLW clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.