Cleared Traditional

K151639 - ABL80 FLEX and ABL80 FLEX CO-OX

K151639 is an FDA 510(k) clearance for ABL80 FLEX and ABL80 FLEX CO-OX, manufactured by Sendx Medical, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K151639 · Sendx Medical, Inc. · Chemistry device
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Dec 2015
Decision
172d
Days
Class 2
Risk

K151639 is an FDA 510(k) clearance for the ABL80 FLEX and ABL80 FLEX CO-OX. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Sendx Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 7, 2015 after a review of 172 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Sendx Medical, Inc. devices

FDA 510(k) Submission Details - K151639

510(k) Number K151639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2015
Decision Date December 07, 2015
Days to Decision 172 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
84d slower than avg
Panel avg: 88d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 Consultant

Radiometer Medical Aps
SOREN BOGESTRAND

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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