Cleared Traditional

K960478 - ACCUMETER H. PYLORI TEST

K960478 is an FDA 510(k) clearance for ACCUMETER H. PYLORI TEST, manufactured by Chemtrak, Inc.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K960478 · Chemtrak, Inc. · Microbiology device
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Jun 1996
Decision
146d
Days
Class 1
Risk

K960478 is an FDA 510(k) clearance for the ACCUMETER H. PYLORI TEST. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Chemtrak, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 27, 1996 after a review of 146 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 Chemtrak, Inc. devices

FDA 510(k) Submission Details - K960478

510(k) Number K960478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1996
Decision Date June 27, 1996
Days to Decision 146 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
44d slower than avg
Panel avg: 102d · This submission: 146d
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 74
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K960478.
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
K952220 · Meretek Diagnostics, Inc. · Sep 1996
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873 · Elias U.S.A., Inc. · Aug 1996
PYLORI IGG ELISA TEST SYSTEM
K961221 · Armkel, LLC · Jul 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
K960183 · Smithkline Diagnostics, Inc. · Jun 1996
HELISAL RAPID BLOOD TEST
K953686 · Cortecs, Ltd. · May 1996
HM-CAP EIA TEST (MODIFICATION)
K955085 · Schiff & Co. · Feb 1996