Cleared Traditional

K820321 - IMMOPHASE B HCG RADIOIMMUNOASSAY

K820321 is the FDA 510(k) clearance for IMMOPHASE B HCG RADIOIMMUNOASSAY by Corning Medical & Scientific. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K820321 · Corning Medical & Scientific · Chemistry device
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Mar 1982
Decision
34d
Days
Class 2
Risk

K820321 is an FDA 510(k) clearance for the IMMOPHASE B HCG RADIOIMMUNOASSAY. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on March 11, 1982 after a review of 34 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 Corning Medical & Scientific devices

Submission Details

510(k) Number K820321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1982
Decision Date March 11, 1982
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K820321.
ROCHE B-HCG RIA
K820613 · Hoffmann-La Roche, Inc. · Apr 1982
ROCHE B-HCG STANDARDS
K820614 · Hoffmann-La Roche, Inc. · Apr 1982
ABBOTT LABORATORIES B-HCG EIA
K820271 · Abbott Laboratories · Mar 1982
TANDEM QUALITATIVE HCG KIT
K812461 · Hybritech, Inc. · Oct 1981
CONCEP-7-BHCG
K812156 · Leeco Diagnostics, Inc. · Aug 1981
HCG RADIOIMMUNOASSAY KIT (125I)
K811421 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1981