FDA product code · Clinical Chemistry
JJYMulti-Analyte Controls, All Kinds (Assayed)
Product code JJY covers Multi-Analyte Controls, All Kinds (Assayed), a Class I device regulated under 21 CFR 862.1660. FDA has cleared 673 devices in this code. Median review time across the 673 most recent decisions is 45 days. openFDA lists 91 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 862.1660
- Review panel
- Clinical Chemistry
- Clearances
- 673
What is happening in JJY right now?
JJY (Multi-Analyte Controls, All Kinds (Assayed)) has one finding. 2 recalls opened in the last 12 months and not yet terminated (Class II, Class III) (Z-0538-2026, Z-0415-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0538-2026, Z-0415-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in JJY?
FDA has cleared 673 devices under product code JJY since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162530 | Multichem IA Plus | Techno-Path Manufacturing | |
| K163629 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | Bio-Rad Laboratories | |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit | Radiometer America, Inc. | |
| K150300 | Liquichek Cardiac Markers Plus Control LT | Bio-Rad Laboratories | |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | |
| K143379 | Liquichek Maternal Serum II Control | Bio-Rad Laboratories | |
| K143573 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | |
| K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. | Randox Laboratories Limited | |
| K142978 | Audit MicroControls Linearity LQ Special Diabetes | Aalto Scientific, Ltd. |
How long does FDA review take for JJY?
The median FDA review time for JJY is 45 days, measured across the 673 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in JJY?
openFDA lists 91 recall records against product code JJY. A recall record covers one firm's corrective action and may span many device lots.
Z-0538-2026Open, ClassifiedPOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.
Z-0415-2026Open, ClassifiedMicrogenics Corporation
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.
Z-1824-2025Open, ClassifiedMckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1838-2025Open, ClassifiedMckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1839-2025Open, ClassifiedMckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Showing the 5 most recently initiated of 91. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for JJY?
MAUDE holds 17 adverse-event reports naming product code JJY, 3 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in JJY unusual?
JJY does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history |
6 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
What are the predicate devices in JJY?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in JJY?
Across the 673 most recent decisions, these applicants filed most often in JJY.
| Applicant | Recent clearances |
|---|---|
| Bio-Rad | 61 |
| Medical Analysis Systems, Inc. | 31 |
| Cliniqa Corporation | 22 |
| Aalto Scientific, Ltd. | 19 |
| Bio-Rad Laboratories | 18 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in JJY file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Bio-Rad Laboratories, Inc. | 26 | 2 |
| Roche Diagnostics Corporation | 22 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch JJY
Get an email the morning anything changes in JJY — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.