FDA product code JIA: Enzymatic Methods, Galactose
JIA is the FDA product code for enzymatic methods, galactose. It is a Class I device, regulated under 21 CFR 862.1310 and reviewed by the Clinical Chemistry panel. FDA has cleared 9 510(k) submissions under JIA, from 8 different applicants. The average 510(k) review took 237 days (median 231). FDA has posted 6 recalls for JIA devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzymatic Methods, Galactose |
| Device class | Class I |
| Regulation | 21 CFR 862.1310 |
| 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 JIA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 265 |
Compare with all 510(k) review times · Search every JIA clearance
Top JIA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quantase , Ltd. | 2 | 1999-06-21 |
| Perkinelmer, Inc. | 1 | 2019-11-06 |
| Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 1 | 2014-04-28 |
| Astoria-Pacific, Inc. | 1 | 2013-06-20 |
| Wallac OY | 1 | 2008-08-07 |
3 more applicants have JIA clearances. See the full list in Caduvo.
Most recent JIA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190335 | Perkinelmer, Inc. | GSP Neonatal Total Galactose kit | 2019-11-06 | 265 |
| K133652 | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | GSP NEONATAL TOTAL GALACTOSE KIT | 2014-04-28 | 152 |
| K121101 | Astoria-Pacific, Inc. | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | 2013-06-20 | 435 |
| K071649 | Wallac OY | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | 2008-08-07 | 416 |
| K990644 | Quantase , Ltd. | QUANTASE TOTAL GALACTOSE SCREENING ASSAY | 1999-06-21 | 115 |
Recalls for JIA devices
6 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-09-08.
Frequently asked questions
What is FDA product code JIA?
JIA is the FDA product code for enzymatic methods, galactose. It is a Class I device, regulated under 21 CFR 862.1310 and reviewed by the Clinical Chemistry panel.
What device class is JIA?
Class I, regulation 21 CFR 862.1310. Typical premarket route: 510(k).
How long does a 510(k) take for product code JIA?
Across 9 cleared submissions the average was 237 days from receipt to decision (median 231).
Which companies have the most JIA clearances?
Quantase , Ltd. (2); Perkinelmer, Inc. (1); Wallac Oy, A Subsidiary of Perkinelmer, Inc. (1); Astoria-Pacific, Inc. (1); Wallac OY (1).
Have JIA devices been recalled?
Yes: 6 product recalls across 3 recall events; the most recent began 2004-09-08.
Next steps
- Run an FDA pathway report with predicate devices for product code JIA
- Run a recall and safety report across every JIA manufacturer
- Watch product code JIA 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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