FDA product code JJW: Urinalysis Controls (Assayed And Unassayed)
JJW is the FDA product code for urinalysis controls (assayed and unassayed). It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel. FDA has cleared 61 510(k) submissions under JJW, from 38 different applicants. The average 510(k) review took 61 days (median 46). FDA has posted 22 recalls for JJW devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Urinalysis Controls (Assayed And Unassayed) |
| Device class | Class I |
| Regulation | 21 CFR 862.1660 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
510(k) clearances per year for JJW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 30 |
Top JJW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Analysis Systems, Inc. | 6 | 2003-07-01 |
| Bio-Rad | 5 | 2003-06-18 |
| Icl Scientific | 3 | 1984-10-05 |
| Helena Laboratories | 3 | 1984-05-01 |
| Miles Laboratories, Inc. | 3 | 1979-02-08 |
33 more applicants have JJW clearances. See the full list in Caduvo.
Most recent JJW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170091 | Streck | UA-Cellular Complete | 2017-02-09 | 30 |
| K142262 | Quantimetrix Corp. | AUTION CHECK PLUS | 2015-04-10 | 239 |
| K131444 | Streck | UA-CELLULAR COMPLETE | 2014-01-29 | 254 |
| K110846 | Randox Laboratories Limited | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 | 2011-09-30 | 186 |
| K103387 | ACON Laboratories, Inc. | MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL | 2011-02-02 | 76 |
Recalls for JJW devices
22 product recalls in 16 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-11-22.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 2 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JJW?
JJW is the FDA product code for urinalysis controls (assayed and unassayed). It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel.
What device class is JJW?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJW?
Across 61 cleared submissions the average was 61 days from receipt to decision (median 46).
Which companies have the most JJW clearances?
Medical Analysis Systems, Inc. (6); Bio-Rad (5); Icl Scientific (3); Helena Laboratories (3); Miles Laboratories, Inc. (3).
Have JJW devices been recalled?
Yes: 22 product recalls across 16 recall events; the most recent began 2025-11-22.
Next steps
- Run an FDA pathway report with predicate devices for product code JJW
- Run a recall and safety report across every JJW manufacturer
- Watch product code JJW 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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