Cleared Traditional

K002023 - MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714

K002023 is an FDA 510(k) clearance for MEDMIRA RAPID H. PYLORI ANTIBODY TEST, manufactured by Medmira Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K002023 · Medmira Laboratories, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Nov 2000
Decision
133d
Days
Class 1
Risk

K002023 is an FDA 510(k) clearance for the MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Medmira Laboratories, Inc. (Halifax, N.S., CA). The FDA issued a Cleared decision on November 13, 2000 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medmira Laboratories, Inc. devices

FDA 510(k) Submission Details - K002023

510(k) Number K002023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2000
Decision Date November 13, 2000
Days to Decision 133 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
31d slower than avg
Panel avg: 102d · This submission: 133d
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 K002023.
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
K022356 · Nichols Institute Diagnostics · Oct 2002
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