Cleared Traditional

K802102 - RUBELLA ELISA REAGENTS RUBELLA IGG ANTI

K802102 is an FDA 510(k) clearance for RUBELLA ELISA REAGENTS RUBELLA IGG ANTI, manufactured by Calbiochem-Behring Corp.. The device is a Class 2 Immunology device with product code GOL cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K802102 · Calbiochem-Behring Corp. · Immunology device
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Dec 1980
Decision
106d
Days
Class 2
Risk

K802102 is an FDA 510(k) clearance for the RUBELLA ELISA REAGENTS RUBELLA IGG ANTI. Classified as Antigen, Ha (including Ha Control), Rubella (product code GOL), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980 after a review of 106 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 Calbiochem-Behring Corp. devices

FDA 510(k) Submission Details - K802102

510(k) Number K802102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1980
Decision Date December 18, 1980
Days to Decision 106 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
1d slower than avg
Panel avg: 105d · This submission: 106d
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 Immunology 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 K802102.
RUBELLA ANTIBODY FLUOROIMMUNOASSAY
K841174 · Intl. Diagnostic Technology · Jun 1984
RUBAQUICK DIAGNOSTIC KIT
K834032 · Abbott Laboratories · Apr 1984
RUBELLA ANTIBODIES TEST REAGENTS
K810309 · Calbiochem-Behring Corp. · Mar 1981
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