FDA product code JLS: Radioimmunoassay, Progesterone
JLS is the FDA product code for radioimmunoassay, progesterone. It is a Class I device, regulated under 21 CFR 862.1620 and reviewed by the Clinical Chemistry panel. FDA has cleared 57 510(k) submissions under JLS, from 43 different applicants. The average 510(k) review took 59 days (median 46). FDA has posted 21 recalls for JLS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Progesterone |
| Device class | Class I |
| Regulation | 21 CFR 862.1620 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JLS clearance
Top JLS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 4 | 1994-12-19 |
| Amersham Corp. | 4 | 1988-11-10 |
| Boehringer Mannheim Corp. | 2 | 1997-03-24 |
| Baxter Diagnostics, Inc. | 2 | 1995-04-11 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1992-02-18 |
38 more applicants have JLS clearances. See the full list in Caduvo.
Most recent JLS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040923 | Ibl GmbH | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA | 2004-07-22 | 105 |
| K973898 | Kmi Diagnostics, Inc. | PROGESTERONE ELISA | 1997-11-13 | 30 |
| K972133 | Johnson & Johnson Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) | 1997-06-24 | 18 |
| K971725 | Behring Diagnostics, Inc. | OPUS PROGESTERONE | 1997-06-18 | 40 |
| K964841 | Boehringer Mannheim Corp. | ELECSYS PROGESTERONE ASSAY | 1997-03-24 | 111 |
Recalls for JLS devices
21 product recalls in 14 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 4 |
| 2019 | 3 |
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code JLS?
JLS is the FDA product code for radioimmunoassay, progesterone. It is a Class I device, regulated under 21 CFR 862.1620 and reviewed by the Clinical Chemistry panel.
What device class is JLS?
Class I, regulation 21 CFR 862.1620. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JLS?
Across 57 cleared submissions the average was 59 days from receipt to decision (median 46).
Which companies have the most JLS clearances?
Diagnostic Products Corp. (4); Amersham Corp. (4); Boehringer Mannheim Corp. (2); Baxter Diagnostics, Inc. (2); Bd Becton Dickinson Vacutainer Systems Preanalytic (2).
Have JLS devices been recalled?
Yes: 21 product recalls across 14 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code JLS
- Run a recall and safety report across every JLS manufacturer
- Watch product code JLS 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.
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