Cleared Traditional

K810835 - RUBAZYME - M

K810835 is an FDA 510(k) clearance for RUBAZYME - M, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code GOK cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K810835 · Abbott Laboratories · Immunology device
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May 1981
Decision
41d
Days
Class 2
Risk

K810835 is an FDA 510(k) clearance for the RUBAZYME - M. Classified as Antisera, Hai (including Hai Control), Rubella (product code GOK), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 5, 1981 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3510 - the FDA immunology 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K810835

510(k) Number K810835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1981
Decision Date May 05, 1981
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 104d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GOK Device Classification - Class 2, Special Controls

Product Code GOK Antisera, Hai (including Hai 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 Immunology devices follow this clearance model.

Regulatory Peers - GOK Antisera, Hai (including Hai Control), Rubella

All 7
Devices cleared under the same product code (GOK) and FDA review panel - the closest regulatory comparables to K810835.
RUBASCAN LATEX CARD TEST
K832228 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
ANTIBODY TO RUBELLA VIRUS
K792635 · Electro-Nucleonics Laboratories, Inc. · Mar 1980
RUBANON
K790122 · Organon, Inc. · Feb 1979
RUBINDEX*DIRECT SYSTEM
K781638 · Ortho Diagnostics, Inc. · Dec 1978
RUBENOSTICON
K780063 · Organon, Inc. · Jan 1978
HUMAN O BUFFER
K771956 · Flow Laboratories, Inc. · Oct 1977