FDA product code · Clinical Chemistry
JLWRadioimmunoassay, Thyroid-Stimulating Hormone
Product code JLW covers Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II device regulated under 21 CFR 862.1690. FDA has cleared 242 devices in this code, 1 of them in the last 12 months. Median review time across the 242 most recent decisions is 57 days. openFDA lists 46 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 862.1690
- Review panel
- Clinical Chemistry
- Clearances
- 242
What is happening in JLW right now?
JLW (Radioimmunoassay, Thyroid-Stimulating Hormone) has two findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0752-2026, Z-0216-2026). The code is crowded, scoring 60 of 100 — 134 companies hold a clearance here and 1 arrived in the last 12 months (JLW:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0752-2026, Z-0216-2026 |
| Crowding | Context | JLW:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in JLW?
FDA has cleared 242 devices under product code JLW since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | Siemens Healthcare Diagnostics | |
| K234091 | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | Genalyte, Inc. | |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | Siemens Healthcare Diagnostics, Inc. | |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | Beckman Coulter, Inc. | |
| K190773 | Elecsys TSH | Roche Diagnostics | |
| K170232 | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer | Boditech Med, Inc. | |
| K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | Fujirebio Diagnostics,Inc. | |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. |
How long does FDA review take for JLW?
The median FDA review time for JLW is 57 days, measured across the 242 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in JLW?
openFDA lists 46 recall records against product code JLW. A recall record covers one firm's corrective action and may span many device lots.
Z-0752-2026Open, ClassifiedGET TESTED INTERNATIONAL AB
Distribution without premarket approval/clearance.
Z-0216-2026Open, ClassifiedBeckman Coulter, Inc.
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
Z-1913-2025Open, ClassifiedBeckman Coulter, Inc.
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Z-1926-2025Open, ClassifiedBeckman Coulter, Inc.
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Z-0094-2025Open, ClassifiedBeckman Coulter, Inc.
Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
Showing the 5 most recently initiated of 46. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for JLW?
MAUDE holds 422 adverse-event reports naming product code JLW, 62 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in JLW unusual?
One month sits above JLW's own expected range: 1 January 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 8 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 5 | 0–23 | Within expected (0–23) | |
| 6 | 0–20 | Within expected (0–20) | |
| 13 | 0–21 | Within expected (0–21) | |
| 17 | 0–23 | Within expected (0–23) | |
| 10 | 3–20 | Within expected (3–20) | |
| 9 | 2–20 | Within expected (2–20) | |
| 6 | 3–31 | Within expected (3–31) | |
| 2 | 0–21 | Within expected (0–21) | |
| 8 | 0–20 | Within expected (0–20) | |
| 8 | 0–18 | Within expected (0–18) | |
| 6 | 0–16 | Within expected (0–16) | |
| 5 | 0–18 | Within expected (0–18) | |
| 20 | 0–20 | Above expected (0–20) | |
| 5 | 0–21 | Within expected (0–21) | |
| 9 | 0–22 | Within expected (0–22) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in JLW.
What are the predicate devices in JLW?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in JLW?
Across the 242 most recent decisions, these applicants filed most often in JLW.
| Applicant | Recent clearances |
|---|---|
| Abbott Laboratories | 10 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 9 |
| Bio-Rad | 9 |
| Diagnostic Products Corp. | 8 |
| Micromedic Systems | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in JLW files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Siemens Healthcare Diagnostics, Inc. | 10 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch JLW
Get an email the morning anything changes in JLW — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.