Cleared Traditional

K901371 - ASO-CUBE(TM)

K901371 is an FDA 510(k) clearance for ASO-CUBE(TM), manufactured by Difco Laboratories, Inc.. The device is a Class 1 Microbiology device with product code GTQ cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K901371 · Difco Laboratories, Inc. · Microbiology device
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May 1990
Decision
53d
Days
Class 1
Risk

K901371 is an FDA 510(k) clearance for the ASO-CUBE(TM). Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 53 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K901371

510(k) Number K901371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1990
Decision Date May 15, 1990
Days to Decision 53 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
49d faster than avg
Panel avg: 102d · This submission: 53d
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 36
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K901371.
TARGET ASO TEST
K910073 · Texas Immunology, Inc. · May 1991
RAPITEX(R) ASL NEW
K903854 · Behring Diagnostics, Inc. · Jan 1991
RHEUMAGEN ASO T-CONTROL
K904311 · Biokit USA, Inc. · Jan 1991
QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)
K894486 · Biokit USA, Inc. · Oct 1989
IMMUNO/ASO
K894780 · Immunostics Co., Inc. · Oct 1989
QUIK-DOT ANTISTREPTOLYSIN-O
K890025 · Ampcor, Inc. · Jan 1989
K901371 · ASO-CUBE(TM)
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