Cleared Traditional

ABL8X7 FLEX (K051968) - FDA 510(k) Clearance

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

K051968 · Radiometer Medical Aps · Chemistry device
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Oct 2006
Decision
453d
Days
Class 2
Risk

K051968 is an FDA 510(k) clearance for the ABL8X7 FLEX. Classified as Electrode, Ion Based, Enzymatic, Creatinine (product code CGL), Class II - Special Controls.

Submitted by Radiometer Medical Aps (Bronshoj, DK). The FDA issued a Cleared decision on October 16, 2006 after a review of 453 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Radiometer Medical Aps devices

Submission Details

510(k) Number K051968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2005
Decision Date October 16, 2006
Days to Decision 453 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
365d slower than avg
Panel avg: 88d · This submission: 453d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGL Electrode, Ion Based, Enzymatic, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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.