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 862.1120](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1120) → CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph # CHL · Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph _Clinical Chemistry · 21 CFR 862.1120 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL ## Overview - **Product Code:** CHL - **Device Name:** Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - **Regulation:** [21 CFR 862.1120](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1120) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **3rd-party reviewable:** yes ## Identification A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 188) Showing 20 most recent of 188 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252207](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K252207.md) | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | Apr 10, 2026 | SESE | | [K244014](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K244014.md) | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | May 2, 2025 | SESE | | [K240998](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K240998.md) | ABL90 FLEX PLUS System | Radiometer Medicals Aps | Dec 13, 2024 | SESE | | [K230285](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K230285.md) | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Oct 27, 2023 | SESE | | [K221900](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K221900.md) | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Sep 29, 2023 | SESE | | [K223857](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K223857.md) | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Sep 15, 2023 | SESE | | [K223608](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K223608.md) | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | Aug 10, 2023 | SESE | | [K211559](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K211559.md) | EasyStat 300 | Medica Corporation | Jan 27, 2023 | SESE | | [K203790](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K203790.md) | GEM Premier 5000 | Instrumentation Laboratory CO | Aug 20, 2021 | SESE | | [K200986](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K200986.md) | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | Aug 2, 2021 | SESE | | [K200107](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K200107.md) | epoc Blood Analysis System | Epocal, Inc. | Jun 5, 2020 | SESE | | [K200492](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K200492.md) | i-STAT CG4+ Cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Apr 9, 2020 | SESE | | [K192240](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K192240.md) | RAPIDPoint 500e Blood Gas System | Siemens Healthcare Diagnostics, Inc. | Mar 27, 2020 | SESE | | [K193246](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K193246.md) | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Jan 24, 2020 | SESE | | [K173797](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K173797.md) | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Jul 17, 2018 | SESE | | [K173403](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K173403.md) | GEM Premier 5000 | Instrumentation Laboratory CO | Dec 29, 2017 | SESE | | [K160412](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K160412.md) | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | Instrumentation Laboratory CO | Dec 14, 2016 | SESE | | [K160153](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K160153.md) | ABL90 FLEX PLUS | Radiometer Medical Aps | Nov 4, 2016 | SESE | | [K151978](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K151978.md) | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control | Edan Instruments, Inc. | Jul 15, 2016 | SESE | | [K151982](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K151982.md) | Stat Profile Prime ABG Analyzer System | Nova Biomedical Corporation | Sep 10, 2015 | SESE | ## Top Applicants - Nova Biomedical Corp. — 20 clearances - Fisher Scientific Co., LLC — 15 clearances - Instrumentation Laboratory CO — 15 clearances - Radiometer America, Inc. — 15 clearances - Radiometer Medical Aps — 13 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL) **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