Cleared Traditional

K896641 - MODIFIED PROLACTIN ENZYME IMMUNOASSAY T...

K896641 is the FDA 510(k) clearance for MODIFIED PROLACTIN ENZYME IMMUNOASSAY T... by Medix Biotech, Inc.. It is a Class 1 Chemistry device (product code CFT) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K896641 · Medix Biotech, Inc. · Chemistry device
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Dec 1989
Decision
33d
Days
Class 1
Risk

K896641 is an FDA 510(k) clearance for the MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on December 27, 1989 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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 Medix Biotech, Inc. devices

Submission Details

510(k) Number K896641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1989
Decision Date December 27, 1989
Days to Decision 33 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
55d faster than avg
Panel avg: 88d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFT Radioimmunoassay, Prolactin (lactogen)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1625
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 - CFT Radioimmunoassay, Prolactin (lactogen)

All 49
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K896641.
COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2
K901578 · Diagnostic Products Corp. · Apr 1990
ENZYMUN TEST(R) PROLACTIN
K900695 · Boehringer Mannheim Corp. · Mar 1990
ABBOTT IMX PROLACTIN
K896162 · Abbott Laboratories · Jan 1990
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY
K894988 · Ciba Corning Diagnostics Corp. · Oct 1989
MILENIA(TM) PROLACTIN (MKPR1,5)
K895003 · Diagnostic Products Corp. · Sep 1989
IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES
K883747 · Diagnostic Products Corp. · Nov 1988