Cleared Traditional

K894780 - IMMUNO/ASO

K894780 is an FDA 510(k) clearance for IMMUNO/ASO, manufactured by Immunostics Co., Inc.. The device is a Class 1 Microbiology device with product code GTQ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K894780 · Immunostics Co., Inc. · Microbiology device
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Oct 1989
Decision
81d
Days
Class 1
Risk

K894780 is an FDA 510(k) clearance for the IMMUNO/ASO. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Immunostics Co., Inc. (Ocean, US). The FDA issued a Cleared decision on October 16, 1989 after a review of 81 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K894780

510(k) Number K894780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1989
Decision Date October 16, 1989
Days to Decision 81 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 102d · This submission: 81d
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 36
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K894780.
RHEUMAGEN ASO T-CONTROL
K904311 · Biokit USA, Inc. · Jan 1991
ASO-CUBE(TM)
K901371 · Difco Laboratories, Inc. · May 1990
QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)
K894486 · Biokit USA, Inc. · Oct 1989
QUIK-DOT ANTISTREPTOLYSIN-O
K890025 · Ampcor, Inc. · Jan 1989
ASO SLIDE TEST
K881209 · Ncs Diagnostics, Inc. · Apr 1988
RAPID AS LATEX
K862530 · Dilab, Inc. · Apr 1987
K894780 · IMMUNO/ASO
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