FDA product code JIR: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JIR is the FDA product code for indicator 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 38 510(k) submissions under JIR, 2 in the last five years, from 28 different applicants. The average 510(k) review took 146 days (median 87). FDA has posted 7 recalls for JIR devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Indicator 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 |
510(k) clearances per year for JIR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 541 |
| 2023 | 1 | 347 |
Compare with all 510(k) review times · Search every JIR clearance
Top JIR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bayer Corp. | 4 | 1999-11-24 |
| Boehringer Mannheim Corp. | 3 | 1995-10-26 |
| Healthy.Io, Ltd. | 2 | 2023-09-08 |
| Teco Diagnostics | 2 | 2007-01-26 |
| Diagnostic Chemicals , Ltd. | 2 | 2000-02-01 |
23 more applicants have JIR clearances. See the full list in Caduvo.
Most recent JIR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222921 | Healthy.Io, Ltd. | Minuteful-kidney test | 2023-09-08 | 347 |
| K210069 | Healthy.Io, Ltd. | Minuteful - kidney test | 2022-07-06 | 541 |
| K150330 | ACON Laboratories, Inc. | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | 2015-04-30 | 79 |
| K061419 | Teco Diagnostics | TECO MICROALBUMIN 2-1 COMBO STRIPS | 2007-01-26 | 249 |
| K022538 | Diagnostic Chemicals, Ltd. (Usa) | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 | 2002-08-23 | 22 |
Recalls for JIR devices
7 product recalls in 6 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2026-07-06.
| Year | Recalls |
|---|---|
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code JIR?
JIR is the FDA product code for indicator 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 JIR?
Class I, regulation 21 CFR 862.1645. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JIR?
Across 38 cleared submissions the average was 146 days from receipt to decision (median 87).
Which companies have the most JIR clearances?
Bayer Corp. (4); Boehringer Mannheim Corp. (3); Healthy.Io, Ltd. (2); Teco Diagnostics (2); Diagnostic Chemicals , Ltd. (2).
Have JIR devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2026-07-06.
Next steps
- Run an FDA pathway report with predicate devices for product code JIR
- Run a recall and safety report across every JIR manufacturer
- Watch product code JIR 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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