FDA product code JJY: Multi-Analyte Controls, All Kinds (Assayed)
JJY is the FDA product code for multi-analyte controls, all kinds (assayed). It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel. FDA has cleared 673 510(k) submissions under JJY, from 167 different applicants. The average 510(k) review took 64 days (median 45). FDA has posted 91 recalls for JJY devices, 21 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Multi-Analyte Controls, All Kinds (Assayed) |
| 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 JJY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 118 |
Compare with all 510(k) review times · Search every JJY clearance
Top JJY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 61 | 2005-04-27 |
| Medical Analysis Systems, Inc. | 31 | 2004-04-28 |
| Cliniqa Corporation | 22 | 2009-04-21 |
| Aalto Scientific, Ltd. | 19 | 2017-03-10 |
| Bio-Rad Laboratories | 18 | 2017-01-10 |
162 more applicants have JJY clearances. See the full list in Caduvo.
Most recent JJY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162530 | Techno-Path Manufacturing | Multichem IA Plus | 2017-03-31 | 203 |
| K163629 | Aalto Scientific, Ltd. | Audit MicroControls Linearity FD Tumor Markers II | 2017-03-10 | 78 |
| K163015 | Bio-Rad Laboratories | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | 2017-01-10 | 74 |
| K153712 | Radiometer America, Inc. | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit | 2016-01-28 | 35 |
| K150300 | Bio-Rad Laboratories | Liquichek Cardiac Markers Plus Control LT | 2015-12-11 | 308 |
Recalls for JJY devices
91 product recalls in 59 recall events; 21 initiated in the last five years and 21 still open. Most recent: 2025-10-06.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2018 | 8 |
| 2019 | 14 |
| 2020 | 9 |
| 2022 | 5 |
| 2023 | 7 |
| 2024 | 4 |
| 2025 | 5 |
Frequently asked questions
What is FDA product code JJY?
JJY is the FDA product code for multi-analyte controls, all kinds (assayed). It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel.
What device class is JJY?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJY?
Across 673 cleared submissions the average was 64 days from receipt to decision (median 45).
Which companies have the most JJY clearances?
Bio-Rad (61); Medical Analysis Systems, Inc. (31); Cliniqa Corporation (22); Aalto Scientific, Ltd. (19); Bio-Rad Laboratories (18).
Have JJY devices been recalled?
Yes: 91 product recalls across 59 recall events; the most recent began 2025-10-06.
Next steps
- Run an FDA pathway report with predicate devices for product code JJY
- Run a recall and safety report across every JJY manufacturer
- Watch product code JJY 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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