Cleared Traditional

K822288 - LH (125I) RADIOIMMUNOASSAY

K822288 is an FDA 510(k) clearance for LH (125I) RADIOIMMUNOASSAY, manufactured by Corning Medical & Scientific. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K822288 · Corning Medical & Scientific · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1982
Decision
45d
Days
Class 1
Risk

K822288 is an FDA 510(k) clearance for the LH (125I) RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on September 13, 1982 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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

FDA 510(k) Submission Details - K822288

510(k) Number K822288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1982
Decision Date September 13, 1982
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

CEP Device Classification - Class 1, General Controls

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEP Radioimmunoassay, Luteinizing Hormone

All 101
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K822288.
LH RIA
K833854 · Syncor Intl. Corp. · Jan 1984
RIANEN LUTEINIZING HORMONE RIA KIT
K833376 · New England Nuclear · Dec 1983
GAMMADAB LH RADIO-KIT #CA-1508
K823476 · Clinical Assays, Inc. · Dec 1982
QUANTIMUNE HLH RIA
K821346 · Bio-Rad · May 1982
LH RADIOIMMUNOASSAY TEST SYSTEM
K820760 · Monobind · Apr 1982
AMERLEX LH RIA KIT (CODE IM2081)
K820753 · Amersham Corp. · Apr 1982