Cleared Traditional

K241037 - ABL90 FLEX PLUS System (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence.

K241037 · Radiometer Medicals Aps · Chemistry device
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Jan 2025
Decision
273d
Days
Class 2
Risk

K241037 is an FDA 510(k) clearance for the ABL90 FLEX PLUS System. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Radiometer Medicals Aps (Brønshøj, DK). The FDA issued a Cleared decision on January 14, 2025 after a review of 273 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 Radiometer Medicals Aps devices

Submission Details

510(k) Number K241037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2024
Decision Date January 14, 2025
Days to Decision 273 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
185d slower than avg
Panel avg: 88d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05804487 Completed Observational Industry-sponsored

ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood

100
Patients (actual)
1
Site
Condition studied Diagnostic Test
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Tejs Jansen
Sponsor Radiometer Medical ApS (industry)
Started 2023-03-14 → Primary completion 2023-08-31
Primary outcome
Repeatability (SD) in whole blood for each parameter, measuring mode and parameter level, pooled across sites.
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov