Cleared Traditional

K781638 - RUBINDEX*DIRECT SYSTEM

K781638 is an FDA 510(k) clearance for RUBINDEX*DIRECT SYSTEM, manufactured by Ortho Diagnostics, Inc.. The device is a Class 2 Immunology device with product code GOK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K781638 · Ortho Diagnostics, Inc. · Immunology device
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Dec 1978
Decision
90d
Days
Class 2
Risk

K781638 is an FDA 510(k) clearance for the RUBINDEX*DIRECT SYSTEM. Classified as Antisera, Hai (including Hai Control), Rubella (product code GOK), Class II - Special Controls.

Submitted by Ortho Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Diagnostics, Inc. devices

FDA 510(k) Submission Details - K781638

510(k) Number K781638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1978
Decision Date December 20, 1978
Days to Decision 90 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
15d faster than avg
Panel avg: 105d · This submission: 90d
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 K781638.
RUBAZYME - M
K810835 · Abbott Laboratories · May 1981
ANTIBODY TO RUBELLA VIRUS
K792635 · Electro-Nucleonics Laboratories, Inc. · Mar 1980
RUBANON
K790122 · Organon, Inc. · Feb 1979
RUBENOSTICON
K780063 · Organon, Inc. · Jan 1978
HUMAN O BUFFER
K771956 · Flow Laboratories, Inc. · Oct 1977
RUBELLA HEMAGGLUTINATION REAGENT KIT
K771957 · Flow Laboratories, Inc. · Oct 1977