Cleared Traditional

K980076 - PREMIER PLATINUM HPSA

K980076 is an FDA 510(k) clearance for PREMIER PLATINUM HPSA, manufactured by Meridian Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K980076 · Meridian Diagnostics, Inc. · Microbiology device
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May 1998
Decision
124d
Days
Class 1
Risk

K980076 is an FDA 510(k) clearance for the PREMIER PLATINUM HPSA. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 12, 1998 after a review of 124 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 Meridian Diagnostics, Inc. devices

FDA 510(k) Submission Details - K980076

510(k) Number K980076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1998
Decision Date May 12, 1998
Days to Decision 124 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
22d slower than avg
Panel avg: 102d · This submission: 124d
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 72
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K980076.
STAT-SIMPLE PYLORI
K980782 · Saliva Diagnostic Systems, Inc. · Aug 1998
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821 · Zeus Scientific, Inc. · Jul 1998
PYLORIPROBE
K981396 · Amdl, Inc. · Jul 1998
SHIELD HELICO-G2 ELISA KIT
K972981 · Shield Diagnostics, Ltd. · Mar 1998
PYLORI DETECT IGG
K973508 · Micro Detect, Inc. · Mar 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523 · Boehringer Mannheim Corp. · Mar 1998