FDA product code JNB: Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
JNB is the FDA product code for ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine. It is a Class II device, regulated under 21 CFR 862.1555 and reviewed by the Clinical Chemistry panel. FDA has cleared 15 510(k) submissions under JNB, from 13 different applicants. The average 510(k) review took 235 days (median 119). FDA has posted 2 recalls for JNB devices.
Classification
| Field | Value |
|---|---|
| Device name | Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine |
| Device class | Class II |
| Regulation | 21 CFR 862.1555 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JNB clearance
Top JNB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quantase , Ltd. | 2 | 2000-06-19 |
| Bio-Rad | 2 | 1996-10-01 |
| Perkinelmer Life Sciences | 1 | 2002-10-28 |
| Micromass, Inc. | 1 | 2001-03-19 |
| Wallac, Inc. | 1 | 1999-02-02 |
8 more applicants have JNB clearances. See the full list in Caduvo.
Most recent JNB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K021541 | Perkinelmer Life Sciences | NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT | 2002-10-28 | 171 |
| K003584 | Micromass, Inc. | NEOLYNX SCREENING APPLICATION MANAGER | 2001-03-19 | 119 |
| K000754 | Quantase , Ltd. | QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT | 2000-06-19 | 103 |
| K984463 | Quantase , Ltd. | QUANTASE PHE/GAL SCREENING ASSAY | 1999-02-16 | 62 |
| K982307 | Wallac, Inc. | WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 | 1999-02-02 | 216 |
Recalls for JNB devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-11-26.
Frequently asked questions
What is FDA product code JNB?
JNB is the FDA product code for ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine. It is a Class II device, regulated under 21 CFR 862.1555 and reviewed by the Clinical Chemistry panel.
What device class is JNB?
Class II, regulation 21 CFR 862.1555. Typical premarket route: 510(k).
How long does a 510(k) take for product code JNB?
Across 15 cleared submissions the average was 235 days from receipt to decision (median 119).
Which companies have the most JNB clearances?
Quantase , Ltd. (2); Bio-Rad (2); Perkinelmer Life Sciences (1); Micromass, Inc. (1); Wallac, Inc. (1).
Have JNB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2012-11-26.
Next steps
- Run an FDA pathway report with predicate devices for product code JNB
- Run a recall and safety report across every JNB manufacturer
- Watch product code JNB 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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