FDA product code JLX: Radioimmunoassay, 17-Hydroxyprogesterone
JLX is the FDA product code for radioimmunoassay, 17-hydroxyprogesterone. It is a Class I device, regulated under 21 CFR 862.1395 and reviewed by the Clinical Chemistry panel. FDA has cleared 19 510(k) submissions under JLX, from 12 different applicants. The average 510(k) review took 167 days (median 84). FDA has posted 3 recalls for JLX devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, 17-Hydroxyprogesterone |
| Device class | Class I |
| Regulation | 21 CFR 862.1395 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JLX clearance
Top JLX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wallac OY | 5 | 2010-07-23 |
| Diagnostic Systems Laboratories, Inc. | 2 | 1994-11-10 |
| Diagnostic Products Corp. | 2 | 1988-02-11 |
| Wien Laboratories, Inc. | 2 | 1984-02-04 |
| Drg Intl., Inc. | 1 | 2008-01-29 |
7 more applicants have JLX clearances. See the full list in Caduvo.
Most recent JLX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100682 | Wallac OY | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | 2010-07-23 | 135 |
| K081922 | Wallac OY | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | 2009-04-16 | 283 |
| K062534 | Drg Intl., Inc. | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE | 2008-01-29 | 518 |
| K060452 | Neo-Genesis | ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH | 2007-03-13 | 385 |
| K050960 | Wallac OY | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | 2005-07-11 | 84 |
Recalls for JLX devices
3 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-09-13.
| Year | Recalls |
|---|---|
| 2023 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code JLX?
JLX is the FDA product code for radioimmunoassay, 17-hydroxyprogesterone. It is a Class I device, regulated under 21 CFR 862.1395 and reviewed by the Clinical Chemistry panel.
What device class is JLX?
Class I, regulation 21 CFR 862.1395. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JLX?
Across 19 cleared submissions the average was 167 days from receipt to decision (median 84).
Which companies have the most JLX clearances?
Wallac OY (5); Diagnostic Systems Laboratories, Inc. (2); Diagnostic Products Corp. (2); Wien Laboratories, Inc. (2); Drg Intl., Inc. (1).
Have JLX devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2024-09-13.
Next steps
- Run an FDA pathway report with predicate devices for product code JLX
- Run a recall and safety report across every JLX manufacturer
- Watch product code JLX 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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