FDA product code · Clinical Chemistry
JIXCalibrator, Multi-Analyte Mixture
Product code JIX covers Calibrator, Multi-Analyte Mixture, a Class II device regulated under 21 CFR 862.1150. FDA has cleared 302 devices in this code. Median review time across the 302 most recent decisions is 48 days. openFDA lists 73 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 862.1150
- Review panel
- Clinical Chemistry
- Clearances
- 302
What is happening in JIX right now?
JIX (Calibrator, Multi-Analyte Mixture) has one finding. 1 recall opened in the last 12 months and not yet terminated (Z-2895-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Serious | Z-2895-2026 |
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 JIX?
FDA has cleared 302 devices under product code JIX since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161140 | VITROS Chemistry Products Calibrator Kit 3 | Ortho-Clinical Diagnostics, Inc. | |
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | Siemens Healthcare Diagnostics, Inc. | |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | Elitechgroup | |
| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) | Siemens Healthcare Diagnostics | |
| K141388 | SYSTEM CALIBRATER | Beckman Coulter Ireland, Inc. | |
| K133330 | C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN | Roche Diagnostics | |
| K130765 | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II | Elitechgroup | |
| K123321 | DIMENSION CHEMISTRY III CALIBRATORY | Siemens Healthcare Diagnostics | |
| K123372 | ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR | Abbott Laboratories | |
| K122398 | RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS | Siemens Healthcare Diagnostics, Inc. |
How long does FDA review take for JIX?
The median FDA review time for JIX is 48 days, measured across the 302 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 JIX?
openFDA lists 73 recall records against product code JIX. A recall record covers one firm's corrective action and may span many device lots.
Z-2895-2026Open, ClassifiedAniara Diagnostica LLC
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
Z-1840-2025Open, 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-1759-2024Open, ClassifiedRandox Laboratories, Limited
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
Z-1328-2024Open, ClassifiedRandox Laboratories, Limited
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Z-0752-2024Open, ClassifiedRandox Laboratories, Limited
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Showing the 5 most recently initiated of 73. 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 JIX?
MAUDE holds 47 adverse-event reports naming product code JIX, 8 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 JIX unusual?
JIX 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 | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | 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 | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 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 | |
| 4 | Insufficient history | No expected range — too little history |
25 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 JIX?
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 JIX?
Across the 302 most recent decisions, these applicants filed most often in JIX.
| Applicant | Recent clearances |
|---|---|
| Alko Diagnostic Corp. | 21 |
| Dade Behring, Inc. | 18 |
| Bhp Diagnostix, Inc. | 11 |
| Roche Diagnostics Corp. | 10 |
| Roche Diagnostic Systems, Inc. | 9 |
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 JIX 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 |
|---|---|---|
| Roche Diagnostics Corporation | 14 | 2 |
| Siemens Healthcare Diagnostics, Inc. | 12 | 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 JIX
Get an email the morning anything changes in JIX — 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.