Cleared Traditional

K002451 - MODIFICATION TO: PRONTO DRY

K002451 is an FDA 510(k) clearance for MODIFICATION TO: PRONTO DRY, manufactured by Medical Instruments Corporation, AG. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K002451 · Medical Instruments Corporation, AG · Microbiology device
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Sep 2000
Decision
51d
Days
Class 1
Risk

K002451 is an FDA 510(k) clearance for the MODIFICATION TO: PRONTO DRY. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Medical Instruments Corporation, AG (Solothurn, CH). The FDA issued a Cleared decision on September 29, 2000 after a review of 51 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 Medical Instruments Corporation, AG devices

FDA 510(k) Submission Details - K002451

510(k) Number K002451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2000
Decision Date September 29, 2000
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 102d · This submission: 51d
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 73
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K002451.
PYLORITEK VP TEST KIT 5140VP
K014038 · Serim Research Corp. · Feb 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
UNI-GOLD H. PYLORI
K991697 · Trinity Biotech, Plc · Dec 1999
IS H. PYLORI IGG ELISA TEST SYSTEM
K990462 · Columbia Bioscience, Inc. · Sep 1999