Cleared Traditional

HCG MAB SOLID PHASE COMPONENT SYSTEM (K871700) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K871700 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Jul 1987
Decision
75d
Days
Class 2
Risk

K871700 is an FDA 510(k) clearance for the HCG MAB 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 July 15, 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 K871700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1987
Decision Date July 15, 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 59
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K871700.
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X
K874033 · Diagnostic Products Corp. · Jan 1988
AFFINITY HCG IMMUNIT (POLYCLONAL)
K873524 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1987
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES
K872130 · Syva Co. · Jul 1987
AFFINITY (TM) HCG IMMUNIT (TM)
K870627 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
ABBOTT TESTPACK HCG COMBO
K870739 · Abbott Laboratories · May 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD
K870672 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1987