Cleared Traditional

K912215 - PYLORITRAK

K912215 is an FDA 510(k) clearance for PYLORITRAK, manufactured by Bainbridge Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K912215 · Bainbridge Laboratories, Inc. · Microbiology device
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Oct 1991
Decision
137d
Days
Class 1
Risk

K912215 is an FDA 510(k) clearance for the PYLORITRAK. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Bainbridge Laboratories, Inc. (Bainbridge Island, US). The FDA issued a Cleared decision on October 4, 1991 after a review of 137 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 Bainbridge Laboratories, Inc. devices

FDA 510(k) Submission Details - K912215

510(k) Number K912215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1991
Decision Date October 04, 1991
Days to Decision 137 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
35d slower than avg
Panel avg: 102d · This submission: 137d
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 75
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K912215.
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
K915851 · Quidel Corp. · Feb 1992
PYLORISET
K904655 · Orion Diagnostica, Inc. · Oct 1991
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
K912255 · Hycor Biomedical, Inc. · Oct 1991
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
K912442 · Quidel Corp. · Sep 1991
EIA FOR DETECTION OF ANTIBODIES H. PYLORI
K905409 · E-Z-Em, Inc. · Jun 1991
PYLORI STAT TEST KIT
K904738 · Whittaker Bioproducts, Inc. · May 1991