Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1150](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1150) → JIX — Calibrator, Multi-Analyte Mixture # JIX · Calibrator, Multi-Analyte Mixture _Clinical Chemistry · 21 CFR 862.1150 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX ## Overview - **Product Code:** JIX - **Device Name:** Calibrator, Multi-Analyte Mixture - **Regulation:** [21 CFR 862.1150](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1150) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.) ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Recent Cleared Devices (20 of 302) Showing 20 most recent of 302 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K161140](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K161140.md) | VITROS Chemistry Products Calibrator Kit 3 | Ortho-Clinical Diagnostics, Inc. | May 20, 2016 | SESE | | [K153365](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K153365.md) | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | Siemens Healthcare Diagnostics, Inc. | Dec 18, 2015 | SESE | | [K151552](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K151552.md) | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | Elitechgroup | Jul 8, 2015 | SESE | | [K140790](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K140790.md) | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) | Siemens Healthcare Diagnostics | Jun 15, 2015 | SESE | | [K141388](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K141388.md) | SYSTEM CALIBRATER | Beckman Coulter Ireland, Inc. | Jul 11, 2014 | SESE | | [K133330](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K133330.md) | C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN | Roche Diagnostics | Nov 26, 2013 | SESE | | [K130765](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K130765.md) | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II | Elitechgroup | Apr 4, 2013 | SESE | | [K123321](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K123321.md) | DIMENSION CHEMISTRY III CALIBRATORY | Siemens Healthcare Diagnostics | Feb 15, 2013 | SESE | | [K123372](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K123372.md) | ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR | Abbott Laboratories | Jan 14, 2013 | SESE | | [K122398](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K122398.md) | RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | Oct 12, 2012 | SESE | | [K112834](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K112834.md) | MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES | Verichem Laboratories, Inc. | Mar 28, 2012 | SESE | | [K112029](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K112029.md) | ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 | Elitechgroup | Aug 30, 2011 | SESE | | [K110394](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K110394.md) | ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) | Vital Diagnostics (Manufacturing) Ptyltd | Jun 9, 2011 | SESE | | [K110251](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K110251.md) | SYNCHRON MULTI CALIBRATOR | Beckman Coulter, Inc. | May 25, 2011 | SESE | | [K103701](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K103701.md) | ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | Feb 18, 2011 | SESE | | [K103171](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K103171.md) | ELECSYS ANTI-TPO CALSET | Roche Diagnostics | Feb 11, 2011 | SESE | | [K103403](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K103403.md) | MULTICONSTITUENT CALIBRATOR | Abbott Laboratories | Feb 4, 2011 | SESE | | [K103612](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K103612.md) | DIMENSION VISA ENZ 2 CAL | Siemens Healthcare Diagnostics, Inc. | Jan 25, 2011 | SESE | | [K101456](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K101456.md) | ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM | Roche Diagnostics | Sep 8, 2010 | SESE | | [K101460](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K101460.md) | LOCI 8 CALIBRATOR, MODEL KC 646 | Siemens Healthcare Diagnostics | Jul 9, 2010 | SESE | ## Top Applicants - Alko Diagnostic Corp. — 21 clearances - Dade Behring, Inc. — 18 clearances - Bhp Diagnostix, Inc. — 11 clearances - Roche Diagnostics Corp. — 10 clearances - Roche Diagnostic Systems, Inc. — 9 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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