Cleared Traditional

K964748 - ELECSYS PROLACTIN ASSAY

K964748 is an FDA 510(k) clearance for ELECSYS PROLACTIN ASSAY, 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 56-day FDA review.

K964748 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
56d
Days
Class 1
Risk

K964748 is an FDA 510(k) clearance for the ELECSYS PROLACTIN ASSAY. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on January 21, 1997 after a review of 56 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 - K964748

510(k) Number K964748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1996
Decision Date January 21, 1997
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
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 K964748.
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
K970281 · Johnson & Johnson Clinical Diagnostics, Inc. · Feb 1997
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
K960561 · Diagnostic Systems Laboratories, Inc. · Apr 1996
DSL ACTIVE PROLACTIN IRMA
K960060 · Diagnostic Systems Laboratories, Inc. · Feb 1996
ACCESS PROLACTIN ASSAY (MODIFICATION)
K954680 · Bio-Rad Laboratories, Inc. · Oct 1995
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
K944698 · Organon Teknika Corp. · Mar 1995
ENZYME-LINKED FLUORESCENT IMMUNOASSAY
K943811 · Biomerieux Vitek, Inc. · Nov 1994