FDA product code JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)
JJX is the FDA product code for single (specified) analyte 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 493 510(k) submissions under JJX, from 145 different applicants. The average 510(k) review took 62 days (median 43). FDA has posted 42 recalls for JJX devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Single (Specified) Analyte 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 JJX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 96 |
Compare with all 510(k) review times · Search every JJX clearance
Top JJX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics | 35 | 2017-04-04 |
| Siemens Healthcare Diagnostics, Inc. | 27 | 2015-07-17 |
| Boehringer Mannheim Corp. | 24 | 1998-08-06 |
| Bionostics, Inc. | 22 | 2013-05-31 |
| Roche Diagnostics Corp. | 22 | 2010-10-05 |
140 more applicants have JJX clearances. See the full list in Caduvo.
Most recent JJX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170678 | Roche Diagnostics | Beta-CrossLaps CalCheck 5 | 2017-04-04 | 29 |
| K162173 | Roche Diagnostics | Elecsys CYFRA 21-1 CalCheck 5 | 2017-01-12 | 162 |
| K162514 | Technopath Manufacturing | Multichem A1c | 2016-10-26 | 48 |
| K161874 | Aalto Scientific, Ltd. | Audit MicroControls Linearity DROP LQ Blood Glucose | 2016-08-10 | 33 |
| K161522 | DiaSorin, Inc. | LIAISON EBV IgM Serum Control Set | 2016-06-30 | 28 |
Recalls for JJX devices
42 product recalls in 33 recall events; 9 initiated in the last five years and 11 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 3 |
| 2023 | 4 |
| 2024 | 2 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code JJX?
JJX is the FDA product code for single (specified) analyte 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 JJX?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJX?
Across 493 cleared submissions the average was 62 days from receipt to decision (median 43).
Which companies have the most JJX clearances?
Roche Diagnostics (35); Siemens Healthcare Diagnostics, Inc. (27); Boehringer Mannheim Corp. (24); Bionostics, Inc. (22); Roche Diagnostics Corp. (22).
Have JJX devices been recalled?
Yes: 42 product recalls across 33 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code JJX
- Run a recall and safety report across every JJX manufacturer
- Watch product code JJX 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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