Cleared Traditional

K014038 - PYLORITEK VP TEST KIT 5140VP

K014038 is an FDA 510(k) clearance for PYLORITEK VP TEST KIT 5140VP, manufactured by Serim Research Corp.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 63-day FDA review.

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

FDA 510(k) Submission Details - K014038

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

LYR Device Classification - Class 1, General Controls

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.

Regulatory Peers - LYR Helicobacter Pylori

All 69
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K014038.
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
K024350 · ACON Laboratories, Inc. · Apr 2003
QUANTA LITE H.PYLORI IGA ELISA
K024334 · Inova Diagnostics, Inc. · Mar 2003
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
K022356 · Nichols Institute Diagnostics · Oct 2002
OXOID PYLORI TEST KIT, MODEL DR0130M
K012588 · Oxoid , Ltd. · Dec 2001
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460 · bioMerieux, Inc. · Oct 2000
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
K000463 · Diagnostic Products Corp. · Jun 2000