Cleared Traditional

K904311 - RHEUMAGEN ASO T-CONTROL

K904311 is the FDA 510(k) clearance for RHEUMAGEN ASO T-CONTROL by Biokit USA, Inc.. It is a Class 1 Microbiology device (product code GTQ) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K904311 · Biokit USA, Inc. · Microbiology device
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Jan 1991
Decision
128d
Days
Class 1
Risk

K904311 is an FDA 510(k) clearance for the RHEUMAGEN ASO T-CONTROL. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on January 25, 1991 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3720 - 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 Biokit USA, Inc. devices

Submission Details

510(k) Number K904311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1990
Decision Date January 25, 1991
Days to Decision 128 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 102d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTQ Antistreptolysin - Titer/streptolysin O Reagent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3720
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.

Regulatory Peers - GTQ Antistreptolysin - Titer/streptolysin O Reagent

All 19
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K904311.
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
K910886 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1991
QM300 CONTROL G PACK
K910887 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1991
RAPITEX(R) ASL NEW
K903854 · Behring Diagnostics, Inc. · Jan 1991
ASO-CUBE(TM)
K901371 · Difco Laboratories, Inc. · May 1990
LASER ASO KIT
K854039 · Behring Diagnostics, Inc. · Oct 1985
ASO SLIDE EIKEN
K853276 · Syn-Kit, Inc. · Aug 1985