Cleared Traditional

LASER ASO KIT (K854039) - FDA 510(k) Clearance

Class I Microbiology device.

K854039 · Behring Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
26d
Days
Class 1
Risk

K854039 is an FDA 510(k) clearance for the LASER ASO KIT. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on October 28, 1985 after a review of 26 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K854039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1985
Decision Date October 28, 1985
Days to Decision 26 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 102d · This submission: 26d
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.