Cleared Traditional

K885107 - THROMBOSTIN IFA*

K885107 is an FDA 510(k) clearance for THROMBOSTIN IFA*, manufactured by Investigacion Farmaceutica S.A. DE C.V.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K885107 · Investigacion Farmaceutica S.A. DE C.V. · Hematology device
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Jun 1989
Decision
193d
Days
Class 2
Risk

K885107 is an FDA 510(k) clearance for the THROMBOSTIN IFA*. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Investigacion Farmaceutica S.A. DE C.V. (Mexico, MX). The FDA issued a Cleared decision on June 23, 1989 after a review of 193 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology 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 Hematology 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 - K885107

510(k) Number K885107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1988
Decision Date June 23, 1989
Days to Decision 193 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 113d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJS Device Classification - Class 2, Special Controls

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 Hematology devices follow this clearance model.

Regulatory Peers - GJS Test, Time, Prothrombin

All 102
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K885107.
THROMBOPLASTIN WITH CALCIUM
K902096 · Sigma Chemical Co. · Jul 1990
THROMBOPLASTIN.C PLUS
K901325 · Baxter Healthcare Corp · May 1990
THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.
K896625 · Medical Diagnostic Technologies, Inc. · Dec 1989
PROTHROMBIN TIME (PT) BY HEMOCHRON
K893378 · International Technidyne Corp. · Jun 1989
HELENA THROMBOPLASTIN REAGENT
K892050 · Helena Laboratories · Jun 1989
DADE THROMBOPLASTIN IS
K891169 · Baxter Healthcare Corp · Apr 1989