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) → JIT — Calibrator, Secondary # JIT · Calibrator, Secondary _Clinical Chemistry · 21 CFR 862.1150 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT ## Overview - **Product Code:** JIT - **Device Name:** Calibrator, Secondary - **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 245) Showing 20 most recent of 245 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K171168](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K171168.md) | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | May 16, 2017 | SESE | | [K170938](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K170938.md) | CalSet IGF-1 | Roche Diagnostics | Apr 26, 2017 | SESE | | [K170160](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K170160.md) | Abbott ARCHITECT Free T3 | Abbott Laboratories | Feb 15, 2017 | SESE | | [K163546](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K163546.md) | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | Jan 13, 2017 | SESE | | [K163534](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K163534.md) | Lumipulse G FSH-N Calibrators | Fujirebio Diagnostics,Inc. | Jan 13, 2017 | SESE | | [K163544](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K163544.md) | Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. | Jan 12, 2017 | SESE | | [K163521](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K163521.md) | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | Jan 12, 2017 | SESE | | [K163078](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K163078.md) | DC-UIBC-CAL | Sekisui Diagnostics P.E.I., Inc. | Dec 8, 2016 | SESE | | [K163053](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K163053.md) | Lumipulse G E2-III Calibrators | Fujirebio Diagnostics,Inc. | Dec 1, 2016 | SESE | | [K162538](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K162538.md) | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | Siemens Healthcare Diagnostics | Nov 17, 2016 | SESE | | [K160113](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K160113.md) | ST AIA-PACK hsE2 Calibrator Set | Tosoh Bioscience, Inc. | Feb 17, 2016 | SESE | | [K153417](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K153417.md) | ST AIA-PACK PROG III Calibrator Set | Tosoh Bioscience, Inc. | Dec 18, 2015 | SESE | | [K152526](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K152526.md) | Elecsys Progesterone III CalSet | Roche Diagnostics | Oct 2, 2015 | SESE | | [K151566](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K151566.md) | Abbott ARCHITECT Total T4 Calibrators | Abbott Laboratories | Jul 10, 2015 | SESE | | [K142985](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K142985.md) | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator | Beckman Coulter, Inc. | Feb 26, 2015 | SESE | | [K143342](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K143342.md) | Elecsys T-Uptake Calset | Roche Diagnostics | Dec 19, 2014 | SESE | | [K143144](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K143144.md) | ST AIA-PACK PROG II Calibrator Set | Tosoh Bioscience, Inc. | Dec 3, 2014 | SESE | | [K142181](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K142181.md) | RANDOX ALDOLASE CALIBRATION SERUM | Randox Laboratories Limited | Sep 18, 2014 | SESE | | [K142021](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K142021.md) | Elecsys Estradiol III CalSet | Roche Diagnostics | Aug 12, 2014 | SESE | | [K133751](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K133751.md) | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS | Diamond Diagnostics, Inc. | Aug 8, 2014 | SESE | ## Top Applicants - Dade Behring, Inc. — 29 clearances - Wako Chemicals USA, Inc. — 15 clearances - E.I. Dupont DE Nemours & Co., Inc. — 10 clearances - Roche Diagnostics Corp. — 10 clearances - Diamond Diagnostics, Inc. — 9 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com