FDA product code JIQ: Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
JIQ is the FDA product code for turbidimetric method, protein or albumin (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1645 and reviewed by the Clinical Chemistry panel. FDA has cleared 13 510(k) submissions under JIQ, from 11 different applicants. The average 510(k) review took 157 days (median 131). FDA has posted 1 recall for JIQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Device class | Class I |
| Regulation | 21 CFR 862.1645 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JIQ clearance
Top JIQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 2 | 1997-04-17 |
| Wako Chemicals USA, Inc. | 2 | 1995-02-07 |
| Roche Diagnostics Operations (Rdo) | 1 | 2014-12-09 |
| Ausam Biotecthnologies, Inc. | 1 | 2003-08-14 |
| Osborn Group, Inc. | 1 | 1999-09-24 |
6 more applicants have JIQ clearances. See the full list in Caduvo.
Most recent JIQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141925 | Roche Diagnostics Operations (Rdo) | TOTAL PROTEIN URINE/CSF GEN.3 | 2014-12-09 | 146 |
| K013643 | Ausam Biotecthnologies, Inc. | AUSAM TOTAL ALBUMIN ASSAY | 2003-08-14 | 647 |
| K991800 | Osborn Group, Inc. | HEMOCHEK URINE COLLECTION KIT | 1999-09-24 | 121 |
| K971458 | Diagnostic Specialties | ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT | 1997-09-02 | 133 |
| K965035 | Beckman Instruments, Inc. | IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT | 1997-04-17 | 121 |
Recalls for JIQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-11-07.
Frequently asked questions
What is FDA product code JIQ?
JIQ is the FDA product code for turbidimetric method, protein or albumin (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1645 and reviewed by the Clinical Chemistry panel.
What device class is JIQ?
Class I, regulation 21 CFR 862.1645. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JIQ?
Across 13 cleared submissions the average was 157 days from receipt to decision (median 131).
Which companies have the most JIQ clearances?
Beckman Instruments, Inc. (2); Wako Chemicals USA, Inc. (2); Roche Diagnostics Operations (Rdo) (1); Ausam Biotecthnologies, Inc. (1); Osborn Group, Inc. (1).
Have JIQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-11-07.
Next steps
- Run an FDA pathway report with predicate devices for product code JIQ
- Run a recall and safety report across every JIQ manufacturer
- Watch product code JIQ 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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