Cleared Traditional

K001177 - PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI

K001177 is an FDA 510(k) clearance for PP-CAP EIA FOR THE DETECTION OF IGA ANT..., manufactured by Enteric Products, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K001177 · Enteric Products, Inc. · Microbiology device
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Nov 2000
Decision
216d
Days
Class 1
Risk

K001177 is an FDA 510(k) clearance for the PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Enteric Products, Inc. (Stony Brook, US). The FDA issued a Cleared decision on November 13, 2000 after a review of 216 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.

FDA 510(k) Submission Details - K001177

510(k) Number K001177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2000
Decision Date November 13, 2000
Days to Decision 216 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 102d · This submission: 216d
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 90
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K001177.
OXOID PYLORI TEST KIT, MODEL DR0130M
K012588 · Oxoid , Ltd. · Dec 2001
HP-ONE
K012411 · Gi Supply · Sep 2001
ELISA TEST, SEROLOGY
K003794 · Micro Detect, Inc. · Mar 2001
MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
K002023 · Medmira Laboratories, Inc. · Nov 2000
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460 · bioMerieux, Inc. · Oct 2000
MODIFICATION TO: PRONTO DRY
K002451 · Medical Instruments Corporation, AG · Sep 2000
K001177 · PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
Download PDF Enteric Products, Inc.