Cleared Traditional

IPAZYME (TM) CHLAMYDIA IGG-IGA (K910644) - FDA 510(k) Clearance

Class I Microbiology device.

K910644 · Savyon Diagnostics , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
33d
Days
Class 1
Risk

K910644 is an FDA 510(k) clearance for the IPAZYME (TM) CHLAMYDIA IGG-IGA. Classified as Antisera, Immunoperoxidase, Chlamydia Spp. (product code LKH), Class I - General Controls.

Submitted by Savyon Diagnostics , Ltd. (Ashdod, IL). The FDA issued a Cleared decision on March 19, 1991 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - 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 Savyon Diagnostics , Ltd. devices

Submission Details

510(k) Number K910644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1991
Decision Date March 19, 1991
Days to Decision 33 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 102d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKH Antisera, Immunoperoxidase, Chlamydia Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
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.