Cleared Traditional

K802508 - RUBELISA IGM TEST KIT

K802508 is an FDA 510(k) clearance for RUBELISA IGM TEST KIT, manufactured by M.A. Bioproducts. The device is a Class 2 Microbiology device with product code GOL cleared through the Traditional 510(k) pathway after a 64-day FDA review.

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

FDA 510(k) Submission Details - K802508

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.

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 17
Devices cleared under the same product code (GOL) and FDA review panel - the closest regulatory comparables to K802508.
RUBELLA ANTIBODIES TEST REAGENTS
K810309 · Calbiochem-Behring Corp. · Mar 1981
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
ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)
K801098 · Flow Laboratories, Inc. · Sep 1980
ANTIGEN CONTROL CELLS
K801507 · Ortho Diagnostics, Inc. · Aug 1980