Cleared Traditional

K890025 - QUIK-DOT ANTISTREPTOLYSIN-O

K890025 is an FDA 510(k) clearance for QUIK-DOT ANTISTREPTOLYSIN-O, manufactured by Ampcor, Inc.. The device is a Class 1 Microbiology device with product code GTQ cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K890025 · Ampcor, Inc. · Microbiology device
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Jan 1989
Decision
27d
Days
Class 1
Risk

K890025 is an FDA 510(k) clearance for the QUIK-DOT ANTISTREPTOLYSIN-O. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Ampcor, Inc. (Bridgeport, US). The FDA issued a Cleared decision on January 31, 1989 after a review of 27 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.

View all Ampcor, Inc. devices

FDA 510(k) Submission Details - K890025

510(k) Number K890025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1989
Decision Date January 31, 1989
Days to Decision 27 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
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 K890025.
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LASER ASO KIT
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K853857 · Texas Immunology, Inc. · Oct 1985
ASO SLIDE EIKEN
K853276 · Syn-Kit, Inc. · Aug 1985