Cleared Traditional

K832801 - OREIA II B-HCG

K832801 is the FDA 510(k) clearance for OREIA II B-HCG by Organon, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K832801 · Organon, Inc. · Chemistry device
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Dec 1983
Decision
112d
Days
Class 2
Risk

K832801 is an FDA 510(k) clearance for the OREIA II B-HCG, ENZYME INNUNOASSAY. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Organon, Inc. (Walker, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Organon, Inc. devices

Submission Details

510(k) Number K832801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date December 08, 1983
Days to Decision 112 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
24d slower than avg
Panel avg: 88d · This submission: 112d
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 182
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K832801.
COATED TUBE HCG IMMUNOASSAY HCG
K841023 · Ventrex Laboratories, Inc. · May 1984
TANDEM VISUAL HCG IMMUNOENZYMETRIC
K834000 · Hybritech, Inc. · Feb 1984
TANDEM R-TOTAL B-GCG KIT
K833194 · Hybritech, Inc. · Jan 1984
BHCG RIA KIT
K831264 · Micromedic Systems · Jun 1983
ARIA II I-HCG
K830997 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1983
DUOCLON SLIDE TEST
K831109 · Organon, Inc. · Jun 1983