Cleared Traditional

K153712 - VK-3 Verification Kit

K153712 is an FDA 510(k) clearance for VK-3 Verification Kit, manufactured by Radiometer America, Inc.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K153712 · Radiometer America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
35d
Days
Class 1
Risk

K153712 is an FDA 510(k) clearance for the VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 V.... Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Radiometer America, Inc. (Brea, US). The FDA issued a Cleared decision on January 28, 2016 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Radiometer America, Inc. devices

FDA 510(k) Submission Details - K153712

510(k) Number K153712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2015
Decision Date January 28, 2016
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Radiometer Medical Aps
Karen Bang Jakobsen

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.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

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