Cleared Traditional

K791854 - CENTRIA HPL RIA

K791854 is an FDA 510(k) clearance for CENTRIA HPL RIA, manufactured by Union Carbide Corp.. The device is a Class 2 Chemistry device with product code JMF cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K791854 · Union Carbide Corp. · Chemistry device
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Oct 1979
Decision
12d
Days
Class 2
Risk

K791854 is an FDA 510(k) clearance for the CENTRIA HPL RIA. Classified as Radioimmunoassay, Human Placental Lactogen (product code JMF), Class II - Special Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1979 after a review of 12 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K791854

510(k) Number K791854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1979
Decision Date October 01, 1979
Days to Decision 12 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
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JMF Device Classification - Class 2, Special Controls

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 8
Devices cleared under the same product code (JMF) and FDA review panel - the closest regulatory comparables to K791854.
HUMAN PLACENTAL LACTOGEN KIT
K823201 · Diagnostic Products Corp. · Nov 1982
NATAL-TEC HPL
K811370 · Armkel, LLC · May 1981
GESTE FOLLOW KIT DETERM. OF HPL
K802454 · Syn-Kit, Inc. · Nov 1980
PROLACTIN RIA DIAG. KIT
K771656 · Abbott Laboratories · Sep 1977
RIALYZE HPL (RIA)
K770659 · Miles Laboratories, Inc. · May 1977