Cleared Traditional

PYLORITEK VP TEST KIT 5140VP (K014038) - FDA 510(k) Clearance

Class I Microbiology device.

K014038 · Serim Research Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
63d
Days
Class 1
Risk

K014038 is an FDA 510(k) clearance for the PYLORITEK VP TEST KIT 5140VP. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on February 8, 2002 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology device 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 Serim Research Corp. devices

Submission Details

510(k) Number K014038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2001
Decision Date February 08, 2002
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYR Helicobacter Pylori
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
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.

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