Cleared Traditional

K800642 - RAPI/TEX ASO STANDARD SERUM

K800642 is an FDA 510(k) clearance for RAPI/TEX ASO STANDARD SERUM, manufactured by Calbiochem-Behring Corp.. The device is a Class 1 Microbiology device with product code GTQ cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K800642 · Calbiochem-Behring Corp. · Microbiology device
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Apr 1980
Decision
31d
Days
Class 1
Risk

K800642 is an FDA 510(k) clearance for the RAPI/TEX ASO STANDARD SERUM. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 31 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 Calbiochem-Behring Corp. devices

FDA 510(k) Submission Details - K800642

510(k) Number K800642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1980
Decision Date April 24, 1980
Days to Decision 31 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
71d faster than avg
Panel avg: 102d · This submission: 31d
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 23
Devices cleared under the same product code (GTQ) and FDA review panel - the closest regulatory comparables to K800642.
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
ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST
K790831 · Icl Scientific · Jun 1979
REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O
K760096 · Gamma Biologicals, Inc. · Aug 1976