Cleared Traditional

K924247 - ACCUTEX ASO LATEX TEST

K924247 is the FDA 510(k) clearance for ACCUTEX ASO LATEX TEST by J.S. Medical Assoc.. It is a Class 1 Microbiology device (product code GTQ) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K924247 · J.S. Medical Assoc. · Microbiology device
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Dec 1992
Decision
105d
Days
Class 1
Risk

K924247 is an FDA 510(k) clearance for the ACCUTEX ASO LATEX TEST. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on December 7, 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 J.S. Medical Assoc. devices

Submission Details

510(k) Number K924247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1992
Decision Date December 07, 1992
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
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.

Regulatory Peers - GTQ Antistreptolysin - Titer/streptolysin O Reagent

All 19
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K924247.
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
K953437 · Olympus America, Inc. · Oct 1995
TURBIQUANT ASL
K915742 · Behring Diagnostics, Inc. · Jun 1993
BECKMAN ANTI-STREPTOLYSIN O KIT
K926236 · Beckman Instruments, Inc. · Jun 1993
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