Cleared Traditional

K900695 - ENZYMUN TEST PROLACTIN

K900695 is an FDA 510(k) clearance for ENZYMUN TEST PROLACTIN, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K900695 · Boehringer Mannheim Corp. · Chemistry device
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Mar 1990
Decision
45d
Days
Class 1
Risk

K900695 is an FDA 510(k) clearance for the ENZYMUN TEST(R) PROLACTIN. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 30, 1990 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K900695

510(k) Number K900695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1990
Decision Date March 30, 1990
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.

CFT Device Classification - Class 1, General Controls

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 52
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K900695.
AFFINITY PROLACTIN TEST SYSTEM
K902698 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
PROLACTIN (LACTOGEN) TEST SYSTEM
K901673 · Baxter Healthcare Corp · Jun 1990
COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2
K901578 · Diagnostic Products Corp. · Apr 1990
ABBOTT IMX PROLACTIN
K896162 · Abbott Laboratories · Jan 1990
MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT
K896641 · Medix Biotech, Inc. · Dec 1989
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY
K894988 · Ciba Corning Diagnostics Corp. · Oct 1989