Cleared Traditional

K003794 - ELISA TEST, SEROLOGY

K003794 is an FDA 510(k) clearance for ELISA TEST, manufactured by Micro Detect, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K003794 · Micro Detect, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
112d
Days
Class 1
Risk

K003794 is an FDA 510(k) clearance for the ELISA TEST, SEROLOGY. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Micro Detect, Inc. (Tustin, US). The FDA issued a Cleared decision on March 30, 2001 after a review of 112 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 Micro Detect, Inc. devices

FDA 510(k) Submission Details - K003794

510(k) Number K003794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2000
Decision Date March 30, 2001
Days to Decision 112 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
10d slower than avg
Panel avg: 102d · This submission: 112d
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 63
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K003794.
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