Cleared Traditional

STAR HCG MONOCLONAL ANTIBODY IMMUNORAD (K832796) - FDA 510(k) Clearance

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

K832796 · Syncor Intl. Corp. · Chemistry device
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Jan 1984
Decision
159d
Days
Class 2
Risk

K832796 is an FDA 510(k) clearance for the STAR HCG MONOCLONAL ANTIBODY IMMUNORAD. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Syncor Intl. Corp. (Mchenry, US). The FDA issued a Cleared decision on January 24, 1984 after a review of 159 days - an extended review 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: 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 Syncor Intl. Corp. devices

Submission Details

510(k) Number K832796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date January 24, 1984
Days to Decision 159 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 88d · This submission: 159d
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 60
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K832796.
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K850570 · American Dade · Apr 1985
EPSILON HCG TEST KIT MONOCLONAL
K842654 · Beckman Instruments, Inc. · Oct 1984
CA-1511, IN VITRO RADIOIMMUNOASSAY
K841821 · Travenol Laboratories, S.A. · Jun 1984
ARIA II I-HCG
K830997 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1983
BETA-COTE B-HCG PREGNANCY SCREENING SYS
K830695 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1983
B-HCG
K822343 · Diagnostic Products Corp. · Sep 1982