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) → JIW — Calibrator, Surrogate # JIW · Calibrator, Surrogate _Clinical Chemistry · 21 CFR 862.1150 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW ## Overview - **Product Code:** JIW - **Device Name:** Calibrator, Surrogate - **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 (17 of 17) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K973055](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K973055.md) | WAKO CH50 LINEARITY SET | Wako Chemicals USA, Inc. | Sep 25, 1997 | SESE | | [K970396](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K970396.md) | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR | Dade Chemistry Systems, Inc. | Feb 20, 1997 | SESE | | [K910255](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K910255.md) | FLOW CYTOMETRY FITC/PE COMPENSATION KIT | Sigma Diagnostics, Inc. | Apr 3, 1991 | SESE | | [K902575](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K902575.md) | SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) | Diagnostic Products Corp. | Oct 4, 1990 | SESE | | [K902294](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K902294.md) | ACCUSCAN MICROBEAD STANDARDS | Sigma Chemical Co. | Jul 3, 1990 | SESE | | [K892213](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K892213.md) | ACS COLLOID OSMOTIC PRESSURE CALIBRATOR | Analytical Control Systems, Inc. | Jun 21, 1989 | SESE | | [K883389](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K883389.md) | RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD | Reagents Applications, Inc. | Dec 14, 1988 | SESE | | [K882220](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K882220.md) | CALIBRATION KIT | King Diagnostics, Inc. | Aug 2, 1988 | SESE | | [K880654](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K880654.md) | AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 | American Research Products Co. | Jun 7, 1988 | SESE | | [K880610](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K880610.md) | UNIMETER CALIBRATION KIT | Boehringer Mannheim Corp. | Mar 24, 1988 | SESE | | [K854028](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K854028.md) | AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER | Verified Medical Research, Inc. | Dec 2, 1985 | SESE | | [K851450](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K851450.md) | FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM | Flow Cytometry Standards Corp. | Sep 16, 1985 | SESE | | [K852260](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K852260.md) | QUICK-CHEM CALIBRATION SET | Seragen Diagnostics, Inc. | Jul 22, 1985 | SESE | | [K812220](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K812220.md) | NEPHELOMETRIC SOLID TURBIDITY STANDARD | Hyland Therapeutic Div., Travenol Laboratories | Aug 18, 1981 | SESE | | [K801300](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K801300.md) | DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) | E.I. Dupont DE Nemours & Co., Inc. | Jul 8, 1980 | SESE | | [K800304](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K800304.md) | CENTRIFICHEM FILTER CALIBRATION SET | Union Carbide Corp. | Mar 12, 1980 | SESE | | [K790643](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW/K790643.md) | CENTRIFICHEM FILTER CALIBRATION SET | Union Carbide Corp. | May 23, 1979 | SESE | ## Top Applicants - Union Carbide Corp. — 2 clearances - American Research Products Co. — 1 clearance - Analytical Control Systems, Inc. — 1 clearance - Boehringer Mannheim Corp. — 1 clearance - Dade Chemistry Systems, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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