Cleared Traditional

K834032 - RUBAQUICK DIAGNOSTIC KIT

K834032 is an FDA 510(k) clearance for RUBAQUICK DIAGNOSTIC KIT, manufactured by Abbott Laboratories. The device is a Class 2 Hematology device with product code GOL cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K834032 · Abbott Laboratories · Hematology device
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Apr 1984
Decision
147d
Days
Class 2
Risk

K834032 is an FDA 510(k) clearance for the RUBAQUICK DIAGNOSTIC KIT. Classified as Antigen, Ha (including Ha Control), Rubella (product code GOL), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.3510 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K834032

510(k) Number K834032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1983
Decision Date April 17, 1984
Days to Decision 147 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 113d · This submission: 147d
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 Hematology 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 K834032.
RUBELLA ANTIBODY FLUOROIMMUNOASSAY
K841174 · Intl. Diagnostic Technology · Jun 1984
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