Cleared Traditional

RUBELISA IGM TEST KIT (K802508) - FDA 510(k) Clearance

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

K802508 · M.A. Bioproducts · Microbiology device
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Dec 1980
Decision
64d
Days
Class 2
Risk

K802508 is an FDA 510(k) clearance for the RUBELISA IGM TEST KIT. Classified as Antigen, Ha (including Ha Control), Rubella (product code GOL), Class II - Special Controls.

Submitted by M.A. Bioproducts (Walker, US). The FDA issued a Cleared decision on December 18, 1980 after a review of 64 days - a notably fast clearance cycle.

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: 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 M.A. Bioproducts devices

Submission Details

510(k) Number K802508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1980
Decision Date December 18, 1980
Days to Decision 64 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 102d · This submission: 64d
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 K802508.
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