Cleared Traditional

AFFINITY HCG TEST SYSTEM (K902720) - FDA 510(k) Clearance

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

K902720 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Aug 1990
Decision
50d
Days
Class 2
Risk

K902720 is an FDA 510(k) clearance for the AFFINITY HCG TEST 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 August 9, 1990 after a review of 50 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 K902720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1990
Decision Date August 09, 1990
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 K902720.
IMX HCG
K912534 · Abbott Laboratories · Jul 1991
IMX TOTAL B-HCG
K912535 · Abbott Laboratories · Jul 1991
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219 · Abbott Laboratories · Sep 1990
KODAK SURECELL(TM) HCG-URINE TEST KIT
K902136 · Eastman Kodak Company · Jun 1990
IMX HCG (LIST #03A63)
K900327 · Abbott Laboratories · Apr 1990
HCG SOLID PHASE COMPONENT SYSTEM
K901045 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990