Cleared Traditional

K801098 - ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)

K801098 is an FDA 510(k) clearance for ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES), manufactured by Flow Laboratories, Inc.. The device is a Class 2 Microbiology device with product code GOL cleared through the Traditional 510(k) pathway after a 130-day FDA review.

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

FDA 510(k) Submission Details - K801098

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
Combination Product No
PCCP Authorized No
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.

GOL Device Classification - Class 2, Special Controls

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 16
Devices cleared under the same product code (GOL) and FDA review panel - the closest regulatory comparables to K801098.
RUBELLA ELISA REAGENTS RUBELLA IGG ANTI
K802102 · Calbiochem-Behring Corp. · Dec 1980
EIA RUBELLA-G
K802339 · Beckman Instruments, Inc. · Dec 1980
GAMMA COAT(125 I) RUBELLA ANTIBODY
K801667 · Clinical Assays, Inc. · Oct 1980
ANTIGEN CONTROL CELLS
K801507 · Ortho Diagnostics, Inc. · Aug 1980
MACRO-VUE RUBELLA CARD TEST
K800797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980
FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD
K792249 · Intl. Diagnostic Technology · Jan 1980