Cleared Traditional

K810309 - RUBELLA ANTIBODIES TEST REAGENTS

K810309 is an FDA 510(k) clearance for RUBELLA ANTIBODIES TEST REAGENTS, 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 34-day FDA review.

K810309 · Calbiochem-Behring Corp. · Immunology device
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Mar 1981
Decision
34d
Days
Class 2
Risk

K810309 is an FDA 510(k) clearance for the RUBELLA ANTIBODIES TEST REAGENTS. Classified as Antigen, Ha (including Ha Control), Rubella (product code GOL), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Walker, US). The FDA issued a Cleared decision on March 11, 1981 after a review of 34 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 Calbiochem-Behring Corp. devices

FDA 510(k) Submission Details - K810309

510(k) Number K810309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1981
Decision Date March 11, 1981
Days to Decision 34 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
71d faster than avg
Panel avg: 105d · This submission: 34d
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 K810309.
RUBELLA ANTIBODY FLUOROIMMUNOASSAY
K841174 · Intl. Diagnostic Technology · Jun 1984
RUBAQUICK DIAGNOSTIC KIT
K834032 · Abbott Laboratories · Apr 1984
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