Cleared Traditional

K812060 - BI-ASO SLIDE TEST

K812060 is an FDA 510(k) clearance for BI-ASO SLIDE TEST, manufactured by Biologics Intl., Inc.. The device is a Class 1 Microbiology device with product code GTQ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K812060 · Biologics Intl., Inc. · Microbiology device
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Aug 1981
Decision
23d
Days
Class 1
Risk

K812060 is an FDA 510(k) clearance for the BI-ASO SLIDE TEST. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Biologics Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 23 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.

View all Biologics Intl., Inc. devices

FDA 510(k) Submission Details - K812060

510(k) Number K812060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1981
Decision Date August 13, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 102d · This submission: 23d
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 K812060.
ASO-CHECK
K831464 · Diagnostic Technology, Inc. · Jun 1983
ASO SURE
K820785 · Analytical Products, Inc. · Apr 1982
ASO SURE PLUS
K820786 · Analytical Products, Inc. · Apr 1982
ASO QUANTUM, ANTISTREPTOLYSIN O TEST
K801177 · Sclavo, Inc. · Jul 1980
RAPI/TEX ASO STANDARD SERUM
K800642 · Calbiochem-Behring Corp. · Apr 1980
ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST
K790831 · Icl Scientific · Jun 1979