Cleared Traditional

K991697 - UNI-GOLD H. PYLORI

K991697 is an FDA 510(k) clearance for UNI-GOLD H. PYLORI, manufactured by Trinity Biotech, Plc. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K991697 · Trinity Biotech, Plc · Microbiology device
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Dec 1999
Decision
217d
Days
Class 1
Risk

K991697 is an FDA 510(k) clearance for the UNI-GOLD H. PYLORI. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Trinity Biotech, Plc (Los Angeles, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 217 days - an extended review 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: 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 Trinity Biotech, Plc devices

FDA 510(k) Submission Details - K991697

510(k) Number K991697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1999
Decision Date December 21, 1999
Days to Decision 217 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
115d slower than avg
Panel avg: 102d · This submission: 217d
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 62
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K991697.
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
IS H. PYLORI IGG ELISA TEST SYSTEM
K990462 · Columbia Bioscience, Inc. · Sep 1999
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
K991820 · Zeus Scientific, Inc. · Aug 1999
QUICKVUE ONE-STEP H. PYLORI II TEST
K991747 · Quidel Corp. · Aug 1999