Cleared Traditional

K973523 - ACCUSTAT H. PYLORI ONE STEP TEST

K973523 is an FDA 510(k) clearance for ACCUSTAT H. PYLORI ONE STEP TEST, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K973523 · Boehringer Mannheim Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
167d
Days
Class 1
Risk

K973523 is an FDA 510(k) clearance for the ACCUSTAT H. PYLORI ONE STEP TEST. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 3, 1998 after a review of 167 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K973523

510(k) Number K973523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1997
Decision Date March 03, 1998
Days to Decision 167 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
65d slower than avg
Panel avg: 102d · This submission: 167d
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 K973523.
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821 · Zeus Scientific, Inc. · Jul 1998
PREMIER PLATINUM HPSA
K980076 · Meridian Diagnostics, Inc. · May 1998
SHIELD HELICO-G2 ELISA KIT
K972981 · Shield Diagnostics, Ltd. · Mar 1998
IMMUNOCARD H. PYLORI
K961508 · Meridian Diagnostics, Inc. · Jan 1997
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873 · Elias U.S.A., Inc. · Aug 1996
PYLORI IGG ELISA TEST SYSTEM
K961221 · Armkel, LLC · Jul 1996