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 862.1225](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1225) → NDY — Test, Cystatin C # NDY · Test, Cystatin C _Clinical Chemistry · 21 CFR 862.1225 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY ## Overview - **Product Code:** NDY - **Device Name:** Test, Cystatin C - **Regulation:** [21 CFR 862.1225](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1225) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **3rd-party reviewable:** yes ## Identification A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 22) Showing 20 most recent of 22 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242585](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K242585.md) | Cystatin C | SENTINEL CH. SpA | May 16, 2025 | SESE | | [K181082](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K181082.md) | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics, Inc. | May 25, 2018 | SESE | | [K171072](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K171072.md) | N Latex Cystatin C; N Protein Standard UY | Siemens Healthcare Diagnostics Products GmbH | May 12, 2017 | SESE | | [K161817](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K161817.md) | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | Jul 27, 2016 | SESE | | [K141143](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K141143.md) | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET | Roche Diagnostics | Jul 17, 2014 | SESE | | [K111664](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K111664.md) | DIAZYME CYSTATIN C POC TEST KIT | Diazyme Laboratories | Mar 30, 2012 | SESE | | [K093137](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K093137.md) | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | Kamiya Biomedical Co. | Sep 28, 2010 | SESE | | [K093960](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K093960.md) | ST AIA-PACK CYSTATIN C, MODEL 025217 | Tosoh Bioscience, Inc. | Sep 14, 2010 | SESE | | [K093680](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K093680.md) | DIAZYME CYSTATIN C ASSAY | Diazyme Laboratories | Apr 8, 2010 | SESE | | [K083906](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K083906.md) | ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 | Siemens Healthcare Diagnostics | Mar 11, 2009 | SESE | | [K081875](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K081875.md) | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | Aug 20, 2008 | SESE | | [K080811](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K080811.md) | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET | Roche Diagnostics Corp. | Jun 20, 2008 | SESE | | [K080384](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K080384.md) | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | The Binding Site, Ltd. | Jun 6, 2008 | SESE | | [K080662](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K080662.md) | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | Genzyme Corporation | May 15, 2008 | SESE | | [K072270](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K072270.md) | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) | Diazyme Laboratories | Feb 1, 2008 | SESE | | [K072166](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K072166.md) | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER | The Binding Site | Jan 24, 2008 | SESE | | [K071388](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K071388.md) | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | Nov 6, 2007 | SESE | | [K063647](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K063647.md) | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH | Thermo Electron OY | Mar 12, 2007 | SESE | | [K063351](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K063351.md) | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH | Dade Behring, Inc. | Jan 22, 2007 | SESE | | [K041627](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY/K041627.md) | CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR | Dako A/S | Sep 3, 2004 | SESE | ## Top Applicants - Dade Behring, Inc. — 3 clearances - Diazyme Laboratories — 3 clearances - Gentian AS — 2 clearances - Dako A/S — 1 clearance - Genzyme Corporation — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NDY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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