Cleared Traditional

K842256 - AS LATEX PLUS

K842256 is the FDA 510(k) clearance for AS LATEX PLUS by Biokit USA, Inc.. It is a Class 1 Microbiology device (product code GTQ) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K842256 · Biokit USA, Inc. · Microbiology device
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Jun 1984
Decision
12d
Days
Class 1
Risk

K842256 is an FDA 510(k) clearance for the AS LATEX PLUS. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Biokit USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984 after a review of 12 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 Biokit USA, Inc. devices

Submission Details

510(k) Number K842256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1984
Decision Date June 19, 1984
Days to Decision 12 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 102d · This submission: 12d
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.

Regulatory Peers - GTQ Antistreptolysin - Titer/streptolysin O Reagent

All 19
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K842256.
LASER ASO KIT
K854039 · Behring Diagnostics, 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