Cleared Traditional

K922723 - TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL

K922723 is an FDA 510(k) clearance for TECH SIMPLE ANTISTREPTOLYSIN O ASO SERU..., manufactured by Simplicity Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code GTQ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

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

FDA 510(k) Submission Details - K922723

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.

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 K922723.
TURBIQUANT ASL
K915742 · Behring Diagnostics, Inc. · Jun 1993
BECKMAN ANTI-STREPTOLYSIN O KIT
K926236 · Beckman Instruments, Inc. · Jun 1993
ACCUTEX ASO LATEX TEST
K924247 · J.S. Medical Assoc. · Dec 1992
BECKMAN ANTISTREPTOLYSIN O, MODIFICATION
K915053 · Beckman Instruments, Inc. · Mar 1992
BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT
K912150 · Beckman Instruments, Inc. · Jul 1991
QM300 CALIBRATOR G PACK
K910885 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1991