Cleared Traditional

K960561 - DSL ACTIVE PROLACTIN ELISA MODEL 10-4500

K960561 is the FDA 510(k) clearance for DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 by Diagnostic Systems Laboratories, Inc.. It is a Class 1 Chemistry device (product code CFT) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K960561 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Apr 1996
Decision
77d
Days
Class 1
Risk

K960561 is an FDA 510(k) clearance for the DSL ACTIVE PROLACTIN ELISA MODEL 10-4500. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on April 26, 1996 after a review of 77 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 Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K960561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1996
Decision Date April 26, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
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 48
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K960561.
ELECSYS PROLACTIN ASSAY
K964748 · Boehringer Mannheim Corp. · Jan 1997
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
AXSYM PROLACTIN
K935675 · Abbott Laboratories · Jun 1994