Cleared Traditional

K854991 - REUMAGEN ASL

K854991 is an FDA 510(k) clearance for REUMAGEN ASL, manufactured by Biokit USA, Inc.. The device is a Class 1 Microbiology device with product code GTQ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K854991 · Biokit USA, Inc. · Microbiology device
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Apr 1986
Decision
127d
Days
Class 1
Risk

K854991 is an FDA 510(k) clearance for the REUMAGEN ASL. 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 April 18, 1986 after a review of 127 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

FDA 510(k) Submission Details - K854991

510(k) Number K854991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1985
Decision Date April 18, 1986
Days to Decision 127 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 102d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

GTQ Device Classification - Class 1, General Controls

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 24
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K854991.
TARGET ASO TEST
K910073 · Texas Immunology, Inc. · May 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
V-TREND ASO PLUS LATEX TEST
K853857 · Texas Immunology, Inc. · Oct 1985
ASO SLIDE EIKEN
K853276 · Syn-Kit, Inc. · Aug 1985