Cleared Traditional

K244014 - i-STAT CG4+ cartridge with the i-STAT 1 System (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K244014 · Abbott Point of Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
127d
Days
Class 2
Risk

K244014 is an FDA 510(k) clearance for the i-STAT CG4+ cartridge with the i-STAT 1 System. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on May 2, 2025 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Point of Care, Inc. devices

Submission Details

510(k) Number K244014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2024
Decision Date May 02, 2025
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 187
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K244014.
ABL90 FLEX PLUS System, safeCLINITUBES
K252207 · Radiometer Medicals Aps · Apr 2026
ABL90 FLEX PLUS System
K240998 · Radiometer Medicals Aps · Dec 2024
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · Abbott Point of Care, Inc. · Oct 2023
Stat Profile Prime Plus Analyzer System
K221900 · Nova Biomedical Corporation · Sep 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · Abbott Point of Care, Inc. · Sep 2023
GEM Premier 7000 with IQM3
K223608 · Instrumentation Laboratory Company · Aug 2023