Cleared Traditional

ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) (K801098) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801098 · Flow Laboratories, Inc. · Microbiology device
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Sep 1980
Decision
130d
Days
Class 2
Risk

K801098 is an FDA 510(k) clearance for the ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES). Classified as Antigen, Ha (including Ha Control), Rubella (product code GOL), Class II - Special Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Flow Laboratories, Inc. devices

Submission Details

510(k) Number K801098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1980
Decision Date September 16, 1980
Days to Decision 130 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 102d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GOL Antigen, Ha (including Ha Control), Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GOL Antigen, Ha (including Ha Control), Rubella

All 20
Devices cleared under the same product code (GOL) and FDA review panel - the closest regulatory comparables to K801098.
RUBAQUICK DIAGNOSTIC KIT
K834032 · Abbott Laboratories · Apr 1984
EIA RUBELLA-G
K802339 · Beckman Instruments, Inc. · Dec 1980
MACRO-VUE RUBELLA CARD TEST
K800797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980
RUBAZYME
K790976 · Abbott Laboratories · Aug 1979
CORDIA T
K790212 · Cordis Corp. · Apr 1979
CORDIA R
K780885 · Cordis Corp. · Jan 1979