Cleared Traditional

K820228 - MIN-MOLECULE PTH BY RADIOIMMUNOASSAY

K820228 is an FDA 510(k) clearance for MIN-MOLECULE PTH BY RADIOIMMUNOASSAY, manufactured by Immuno Nuclear Corp.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K820228 · Immuno Nuclear Corp. · Chemistry device
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Mar 1982
Decision
43d
Days
Class 2
Risk

K820228 is an FDA 510(k) clearance for the MIN-MOLECULE PTH BY RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Immuno Nuclear Corp. (Walker, US). The FDA issued a Cleared decision on March 11, 1982 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1545 - 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 Immuno Nuclear Corp. devices

FDA 510(k) Submission Details - K820228

510(k) Number K820228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1982
Decision Date March 11, 1982
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEW Device Classification - Class 2, Special Controls

Product Code CEW Radioimmunoassay, Parathyroid Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1545
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 - CEW Radioimmunoassay, Parathyroid Hormone

All 75
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K820228.
DAC-CEL PTH KIT RD51
K831069 · Wellcome Diagnostics · Jun 1983
HUMAN INTRACT PARATHYROID HORMONE BY
K830664 · Immuno Nuclear Corp. · May 1983
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
K822944 · Travenol Laboratories, S.A. · Dec 1982
C-TERMINAL PTH RIA TEST KIT, DSL-1000
K813203 · Diagnostic Systems Laboratories, Inc. · Dec 1981
C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT
K811566 · Immuno Nuclear Corp. · Jun 1981
N-TERMINAL HPTH BY RIA
K811418 · Immuno Nuclear Corp. · Jun 1981