Cleared Traditional

K864591 - HCG SOLID PHASE COMPONENT SYSTEM

K864591 is the FDA 510(k) clearance for HCG SOLID PHASE COMPONENT SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K864591 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 1987
Decision
75d
Days
Class 2
Risk

K864591 is an FDA 510(k) clearance for the HCG SOLID PHASE COMPONENT SYSTEM. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K864591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1986
Decision Date February 04, 1987
Days to Decision 75 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 88d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 206
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K864591.
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
K870106 · Diagnostic Products Corp. · Mar 1987
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
K865057 · Hybritech, Inc. · Mar 1987
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
K870259 · Leeco Diagnostics, Inc. · Mar 1987
VIS-CUBE HCG (EIA)
K863933 · Leeco Diagnostics, Inc. · Dec 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
K863861 · Hybritech, Inc. · Nov 1986
ABBOTT TESTPACK (TM) HCG SERUM
K863032 · Abbott Laboratories · Sep 1986