Cleared Traditional

K885113 - IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL

K885113 is an FDA 510(k) clearance for IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL, manufactured by Investigacion Farmaceutica S.A. DE C.V.. The device is a Class 2 Microbiology device with product code GSN cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K885113 · Investigacion Farmaceutica S.A. DE C.V. · Microbiology device
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Aug 1989
Decision
246d
Days
Class 2
Risk

K885113 is an FDA 510(k) clearance for the IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL. Classified as Antiserum, Positive And Negative Febrile Antigen Control Serum (product code GSN), Class II - Special 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 866.3085 - 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 - K885113

510(k) Number K885113 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. No clinical trials required.

GSN Device Classification - Class 2, Special Controls

Product Code GSN Antiserum, Positive And Negative Febrile Antigen Control Serum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3085
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.