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) → JIS — Calibrator, Primary # JIS · Calibrator, Primary _Clinical Chemistry · 21 CFR 862.1150 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS ## Overview - **Product Code:** JIS - **Device Name:** Calibrator, Primary - **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 130) Showing 20 most recent of 130 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K122126](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K122126.md) | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR | Randox Laboratories Limited | Aug 14, 2012 | SESE | | [K061251](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K061251.md) | DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR | Dade Behring, Inc. | May 31, 2006 | SESE | | [K060266](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K060266.md) | DIMENSION IRON CALIBRATOR | Dade Behring, Inc. | Mar 9, 2006 | SESE | | [K053104](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K053104.md) | DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR | Dade Behring, Inc. | Dec 23, 2005 | SESE | | [K032697](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K032697.md) | DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) | Dade Behring, Inc. | Nov 7, 2003 | SESE | | [K032608](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K032608.md) | GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | Oct 21, 2003 | SESE | | [K032296](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K032296.md) | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | Aug 13, 2003 | SESE | | [K030964](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K030964.md) | CALIBRATION PLASMA LMW HEPARIN | Instrumentation Laboratory CO | Jun 6, 2003 | SESE | | [K030546](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K030546.md) | CRP (II) CALIBRATORS | Denka Seiken Co., Ltd. | Jun 2, 2003 | SESE | | [K030320](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K030320.md) | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET | Wako Chemicals USA, Inc. | Apr 11, 2003 | SESE | | [K022682](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K022682.md) | RANDOX C-REACTIVE PROTEIN CALIBRATOR | Randox Laboratories, Ltd. | Nov 5, 2002 | SESE | | [K022901](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K022901.md) | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics | Sep 27, 2002 | SESE | | [K013126](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K013126.md) | N LP(A) STANDARD SY | Dade Behring, Inc. | Nov 9, 2001 | SESE | | [K012878](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K012878.md) | THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 | Thermo Dma, Inc. | Oct 16, 2001 | SESE | | [K011568](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K011568.md) | RANDOX LIPOPROTEIN | Randox Laboratories, Ltd. | Sep 28, 2001 | SESE | | [K010696](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K010696.md) | BECKMAN COULTER DNASE B CALIBRATOR | Beckman Coulter, Inc. | May 10, 2001 | SESE | | [K003941](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K003941.md) | ELECSYS HCG STAT CLASET II | Roche Diagnostics Corp. | Jan 25, 2001 | SESE | | [K003969](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K003969.md) | ELECSYS CA 125 II CALSET | Roche Diagnostics Corp. | Jan 12, 2001 | SESE | | [K002760](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K002760.md) | ELECSYS DHEA-S CALSET | Roche Diagnostics Corp. | Oct 5, 2000 | SESE | | [K002353](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K002353.md) | ELECSYS CA 15-3 CALCHECK | Roche Diagnostics Corp. | Aug 10, 2000 | SESE | ## Top Applicants - E.I. Dupont DE Nemours & Co., Inc. — 8 clearances - Wako Chemicals USA, Inc. — 7 clearances - Beckman Coulter, Inc. — 6 clearances - Dade Behring, Inc. — 6 clearances - Syva Co. — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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