Cleared Traditional

K885110 - PROTEUS OX-19 IFA*

K885110 is an FDA 510(k) clearance for PROTEUS OX-19 IFA*, manufactured by Investigacion Farmaceutica S.A. DE C.V.. The device is a Class 1 Microbiology device with product code GSZ cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K885110 · Investigacion Farmaceutica S.A. DE C.V. · Microbiology device
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Aug 1989
Decision
246d
Days
Class 1
Risk

K885110 is an FDA 510(k) clearance for the PROTEUS OX-19 IFA*. Classified as Antigens, Febrile (weil-felix), All Groups (product code GSZ), Class I - General Controls.

Submitted by Investigacion Farmaceutica S.A. DE C.V. (Mexico, MX). The FDA issued a Cleared decision on August 15, 1989 after a review of 246 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3410 - 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 Investigacion Farmaceutica S.A. DE C.V. devices

FDA 510(k) Submission Details - K885110

510(k) Number K885110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1988
Decision Date August 15, 1989
Days to Decision 246 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 102d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

GSZ Device Classification - Class 1, General Controls

Product Code GSZ Antigens, Febrile (weil-felix), All Groups
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3410
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.