Cleared Traditional

K823292 - IMMOPHASE TM HPL RADIOIMMUNOASSAY

K823292 is the FDA 510(k) clearance for IMMOPHASE TM HPL RADIOIMMUNOASSAY by Corning Medical & Scientific. It is a Class 2 Chemistry device (product code JMF) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K823292 · Corning Medical & Scientific · Chemistry device

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Dec 1982

Decision

53d

Days

Class 2

Risk

K823292 is an FDA 510(k) clearance for the IMMOPHASE TM HPL RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Human Placental Lactogen (product code JMF), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1585 - 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	K823292 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 05, 1982
Decision Date	December 28, 1982
Days to Decision	53 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

35d faster than avg

Panel avg: 88d · This submission: 53d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	JMF Radioimmunoassay, Human Placental Lactogen
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1585

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 - JMF Radioimmunoassay, Human Placental Lactogen

All 7

Devices cleared under the same product code (JMF) and FDA review panel - the closest regulatory comparables to K823292.

IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)

K944933 · Diagnostic Products Corp. · Mar 1995

AMERLEX HUMAN PLACENTAL LACTOGEN

K840588 · Amersham Corp. · Apr 1984

HUMAN PLACENTAL LACTOGEN KIT

K823201 · Diagnostic Products Corp. · Nov 1982

NATAL-TEC HPL

K811370 · Armkel, LLC · May 1981

CENTRIA HPL RIA

K791854 · Union Carbide Corp. · Oct 1979

PROLACTIN RIA DIAG. KIT

K771656 · Abbott Laboratories · Sep 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K823292

Corning Medical & Scientific

Mchenry, IL · US

Regulatory profile

111 submissions 111 cleared

100% clearance rate · Active in Chemistry

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Sourced from FDA 510(k) public files . Updated monthly.

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