Cleared Traditional

TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (K922723) - FDA 510(k) Clearance

Class I Microbiology device.

K922723 · Simplicity Diagnostics, Inc. · Microbiology device
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Sep 1992
Decision
105d
Days
Class 1
Risk

K922723 is an FDA 510(k) clearance for the TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Simplicity Diagnostics, Inc. (Hatboro, US). The FDA issued a Cleared decision on September 18, 1992 after a review of 105 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 Simplicity Diagnostics, Inc. devices

Submission Details

510(k) Number K922723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1992
Decision Date September 18, 1992
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 102d · This submission: 105d
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.