Cleared Traditional

K964675 - H.PYLORI CONTROLS

K964675 is an FDA 510(k) clearance for H.PYLORI CONTROLS, manufactured by Pyramid Biological Corp.. The device is a Class 1 Microbiology device with product code LYR cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K964675 · Pyramid Biological Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
67d
Days
Class 1
Risk

K964675 is an FDA 510(k) clearance for the H.PYLORI CONTROLS. Classified as Helicobacter Pylori (product code LYR), Class I - General Controls.

Submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on January 27, 1997 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pyramid Biological Corp. devices

FDA 510(k) Submission Details - K964675

510(k) Number K964675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1996
Decision Date January 27, 1997
Days to Decision 67 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
35d faster than avg
Panel avg: 102d · This submission: 67d
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 62
Devices cleared under the same product code (LYR) and FDA review panel - the closest regulatory comparables to K964675.
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
K972146 · Consolidated Technologies, Inc. · Jul 1997
PYLORISET EIA-G (68926)
K971537 · Orion Diagnostica, Div. Orion Corp. · Jun 1997
ACCUMETER H. PYLORI TEST
K965099 · Chemtrak, Inc. · Feb 1997
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