Cleared Traditional

K831464 - ASO-CHECK

K831464 is an FDA 510(k) clearance for ASO-CHECK, manufactured by Diagnostic Technology, Inc.. The device is a Class 1 Immunology device with product code GTQ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K831464 · Diagnostic Technology, Inc. · Immunology device
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Jun 1983
Decision
41d
Days
Class 1
Risk

K831464 is an FDA 510(k) clearance for the ASO-CHECK. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Diagnostic Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3720 - the FDA immunology 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 Diagnostic Technology, Inc. devices

FDA 510(k) Submission Details - K831464

510(k) Number K831464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1983
Decision Date June 16, 1983
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 104d · This submission: 41d
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 21
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K831464.
V-TREND ASO PLUS LATEX TEST
K853857 · Texas Immunology, Inc. · Oct 1985
ASO SLIDE EIKEN
K853276 · Syn-Kit, Inc. · Aug 1985
SERIMM SURE ASO-CHEK CONTROL SERUM
K842839 · Analytical Products, Inc. · Aug 1984
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