Cleared Traditional

K924247 - ACCUTEX ASO LATEX TEST

K924247 is an FDA 510(k) clearance for ACCUTEX ASO LATEX TEST, manufactured by J.S. Medical Assoc.. 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.

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

FDA 510(k) Submission Details - K924247

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
Combination Product No
PCCP Authorized No
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 23
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