Cleared Traditional

K802454 - GESTE FOLLOW KIT DETERM. OF HPL

K802454 is the FDA 510(k) clearance for GESTE FOLLOW KIT DETERM. OF HPL by Syn-Kit, Inc.. It is a Class 2 Immunology device (product code JMF) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K802454 · Syn-Kit, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1980
Decision
35d
Days
Class 2
Risk

K802454 is an FDA 510(k) clearance for the GESTE FOLLOW KIT DETERM. OF HPL. Classified as Radioimmunoassay, Human Placental Lactogen (product code JMF), Class II - Special Controls.

Submitted by Syn-Kit, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1585 - the FDA immunology device 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 Syn-Kit, Inc. devices

Submission Details

510(k) Number K802454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1980
Decision Date November 12, 1980
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 104d · This submission: 35d
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 Immunology 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 K802454.
IMMOPHASE TM HPL RADIOIMMUNOASSAY
K823292 · Corning Medical & Scientific · Dec 1982
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
RIALYZE HPL (RIA)
K770659 · Miles Laboratories, Inc. · May 1977