Cleared Traditional

IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) (K901975) - FDA 510(k) Clearance

Class I Microbiology device.

K901975 · Savyon Diagnostics , Ltd. · Microbiology device
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Mar 1991
Decision
311d
Days
Class 1
Risk

K901975 is an FDA 510(k) clearance for the IPAZYME(TM) CHLAMYDIA TRUE IGM(TM). 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 8, 1991 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Savyon Diagnostics , Ltd. devices

Submission Details

510(k) Number K901975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date March 08, 1991
Days to Decision 311 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 102d · This submission: 311d
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.