Cleared Traditional

K980798 - BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-...

K980798 is an FDA 510(k) clearance for BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-..., manufactured by Princeton BioMeditech Corp.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K980798 · Princeton BioMeditech Corp. · Microbiology device
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Sep 1998
Decision
204d
Days
Class 1
Risk

K980798 is an FDA 510(k) clearance for the BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 204 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 Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K980798

510(k) Number K980798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1998
Decision Date September 22, 1998
Days to Decision 204 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
102d slower than avg
Panel avg: 102d · This submission: 204d
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 50
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K980798.
MODIFICATION TO: PREMIER PLATINUM HPSA
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PREMIER PLATINUM HPSA
K980076 · Meridian Diagnostics, Inc. · May 1998
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K972981 · Shield Diagnostics, Ltd. · Mar 1998