Cleared Traditional

K830997 - ARIA II I-HCG

K830997 is the FDA 510(k) clearance for ARIA II I-HCG by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Immunology device (product code JHI) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K830997 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
65d
Days
Class 2
Risk

K830997 is an FDA 510(k) clearance for the ARIA II I-HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1155 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K830997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1983
Decision Date June 02, 1983
Days to Decision 65 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
39d faster than avg
Panel avg: 104d · This submission: 65d
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 Immunology 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 K830997.
OREIA II B-HCG, ENZYME INNUNOASSAY
K832801 · Organon, Inc. · Dec 1983
BHCG RIA KIT
K831264 · Micromedic Systems · Jun 1983
PBI BHCG RIA KIT
K831302 · Pacific Biotech, Inc. · Jun 1983
DUOCLON SLIDE TEST
K831109 · Organon, Inc. · Jun 1983
BETA-QUIK-15 RIA KIT
K831223 · Pacific Biotech, Inc. · Jun 1983
B-GCG SYSTEM BY RIA
K830526 · Pcl-Ria, Inc. · Apr 1983