Cleared Traditional

K911047 - OBA(TM) SERUM HCG ASSAY

K911047 is an FDA 510(k) clearance for OBA(TM) SERUM HCG ASSAY, manufactured by Adeza Biomedical. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K911047 · Adeza Biomedical · Chemistry device
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Jun 1991
Decision
108d
Days
Class 2
Risk

K911047 is an FDA 510(k) clearance for the OBA(TM) SERUM HCG ASSAY. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Adeza Biomedical (Sunnyvale, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 108 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 Adeza Biomedical devices

FDA 510(k) Submission Details - K911047

510(k) Number K911047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1991
Decision Date June 24, 1991
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

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 294
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K911047.
IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
K911826 · Disease Detection International, Inc. · Jul 1991
IMX HCG
K912534 · Abbott Laboratories · Jul 1991
IMX TOTAL B-HCG
K912535 · Abbott Laboratories · Jul 1991
CLEARVIEW HCG SERUM/URINE
K905741 · Unipath , Ltd. · May 1991
TARGET(TM) HOG ONE STEP
K903937 · V-Tech, Inc. · Oct 1990
CIBA CORNING ACS HCG IMMUNOASSAY
K904123 · Ciba Corning Diagnostics Corp. · Oct 1990