FDA product code JLW: Radioimmunoassay, Thyroid-Stimulating Hormone
JLW is the FDA product code for radioimmunoassay, thyroid-stimulating hormone. It is a Class II device, regulated under 21 CFR 862.1690 and reviewed by the Clinical Chemistry panel. FDA has cleared 242 510(k) submissions under JLW, 6 in the last five years, from 137 different applicants. The average 510(k) review took 86 days (median 57); 207 days on average over the last three years. FDA has posted 46 recalls for JLW devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Thyroid-Stimulating Hormone |
| Device class | Class II |
| Regulation | 21 CFR 862.1690 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JLW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 196 |
| 2019 | 1 | 21 |
| 2022 | 1 | 196 |
| 2023 | 1 | 360 |
| 2024 | 2 | 200 |
| 2025 | 1 | 158 |
| 2026 | 1 | 262 |
Compare with all 510(k) review times · Search every JLW clearance
Top JLW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 10 | 1998-11-20 |
| Bio-Rad | 9 | 1994-12-19 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 9 | 1991-06-20 |
| Siemens Healthcare Diagnostics, Inc. | 8 | 2026-02-06 |
| Diagnostic Products Corp. | 8 | 1995-03-13 |
132 more applicants have JLW clearances. See the full list in Caduvo.
Most recent JLW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251543 | Siemens Healthcare Diagnostics, Inc. | Atellica® IM TSH3-Ultra II (TSH3ULII) | 2026-02-06 | 262 |
| K243570 | Siemens Healthcare Diagnostics | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | 2025-04-25 | 158 |
| K234091 | Genalyte, Inc. | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | 2024-07-22 | 209 |
| K233050 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | 2024-04-04 | 192 |
| K222116 | Siemens Healthcare Diagnostics, Inc. | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | 2023-07-13 | 360 |
Recalls for JLW devices
46 product recalls in 31 recall events; 8 initiated in the last five years and 12 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 8 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2024 | 2 |
| 2025 | 4 |
Frequently asked questions
What is FDA product code JLW?
JLW is the FDA product code for radioimmunoassay, thyroid-stimulating hormone. It is a Class II device, regulated under 21 CFR 862.1690 and reviewed by the Clinical Chemistry panel.
What device class is JLW?
Class II, regulation 21 CFR 862.1690. Typical premarket route: 510(k).
How long does a 510(k) take for product code JLW?
Across 242 cleared submissions the average was 86 days from receipt to decision (median 57).
Which companies have the most JLW clearances?
Abbott Laboratories (10); Bio-Rad (9); Bd Becton Dickinson Vacutainer Systems Preanalytic (9); Siemens Healthcare Diagnostics, Inc. (8); Diagnostic Products Corp. (8).
Have JLW devices been recalled?
Yes: 46 product recalls across 31 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JLW
- Run a recall and safety report across every JLW manufacturer
- Watch product code JLW 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times