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) → CGX — Alkaline Picrate, Colorimetry, Creatinine # CGX · Alkaline Picrate, Colorimetry, Creatinine _Clinical Chemistry · 21 CFR 862.1225 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX ## Overview - **Product Code:** CGX - **Device Name:** Alkaline Picrate, Colorimetry, Creatinine - **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 159) Showing 20 most recent of 159 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252206](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K252206.md) | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Jan 9, 2026 | SESE | | [K251058](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K251058.md) | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | Nov 26, 2025 | SESE | | [K242685](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K242685.md) | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | Dec 4, 2024 | SESE | | [K221813](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K221813.md) | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Nov 19, 2024 | SESE | | [K210452](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K210452.md) | Creatinine2 | Abbott Ireland Diagnostics Division | Mar 22, 2022 | SESE | | [K161494](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K161494.md) | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | Siemens Healthcare Diagnostics, Inc. | Nov 15, 2016 | SESE | | [K132638](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K132638.md) | DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics, Inc. | Jan 27, 2014 | SESE | | [K133728](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K133728.md) | DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics, Inc. | Jan 24, 2014 | SESE | | [K123586](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K123586.md) | EASYRA CREATININE REAGENT | Medica Corporation | May 15, 2013 | SESE | | [K110530](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K110530.md) | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL | HORIBA ABX SAS | Apr 30, 2012 | SESE | | [K083809](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K083809.md) | CREATININE | Abbott Laboratories | Apr 7, 2009 | SESE | | [K072115](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K072115.md) | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H | Horiba Abx | Nov 30, 2007 | SESE | | [K071283](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K071283.md) | SYNCHRON SYSTEMS CREATININE REAGENT | Beckman Coulter, Inc. | Jun 1, 2007 | SESE | | [K071280](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K071280.md) | SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | Beckman Coulter, Inc. | Jun 1, 2007 | SESE | | [K071277](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K071277.md) | SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | Beckman Coulter, Inc. | Jun 1, 2007 | SESE | | [K061193](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K061193.md) | CREATININE | Abbott Laboratories, Inc. | Jun 23, 2006 | SESE | | [K060935](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K060935.md) | SYNCHRON SYSTEMS CREATININE (CREA) REAGENT | Beckman Coulter, Inc. | Apr 28, 2006 | SESE | | [K050652](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K050652.md) | SPOTCHEM II CREATININE, AMYLASE & ALP TESTS | Arkray, Inc. | Apr 6, 2005 | SESE | | [K040976](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K040976.md) | GENCHEM CREATININE REAGENT | Genchem, Inc. | Dec 27, 2004 | SESE | | [K033058](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K033058.md) | CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS | Diamond Diagnostics, Inc. | Jan 30, 2004 | SESE | ## Top Applicants - Em Diagnostic Systems, Inc. — 10 clearances - Harleco — 8 clearances - Abbott Laboratories — 7 clearances - Olympus Corp. — 6 clearances - Beckman Coulter, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX) **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